"I have been speaking to Coca-Cola about using REAL Cane Sugar in Coke in the United States, and they have agreed to do so...This will be a very good move by them — You'll see. It's just better!"

That was President Donald Trump, in a recent post on his social media platform, touting that Coca-Cola would reportedly introduce an American-made version of its iconic soda sweetened with cane sugar instead of high-fructose corn syrup.

Some versions of Coke already use cane sugar, including Coca-Cola sold in Mexico.

Coca-Cola has since revealed that it will launch an offering made with U.S. cane sugar as part of its product line.

“This addition is designed to complement the company’s strong core portfolio and offer more choices across occasions and preferences,” Coca-Cola reported in its Q2 2025 earnings release.

Still, the announcement has reignited debates about U.S. sugar policy and, in some cases, soda taxes.

Will consumers bear the costs of Trump’s push for cane sugar Coke? Here’s more of what you need to know.

Cane sugar vs corn syrup: Which is healthier?

The cane sugar Coke debate raises a key question: Why do many U.S. sodas use high-fructose corn syrup (HFCS) instead of cane sugar? Well, it primarily comes down to cost and policy.

• Since the 1980s, U.S. rules, tariffs, and quotas have led to cane sugar being more expensive.
• Corn is subsidized by the federal government, which helps make HFCS cheaper for soda companies.

Taste-wise, some people say sodas with cane sugar, like “Mexican Coke,” taste cleaner or more natural. Others feel that HFCS-sweetened sodas are slightly sweeter.

But from a health effects perspective, both sweeteners are similar, according to the U.S. Food and Drug Administration (FDA).

Specifically, the food agency reports that cane sugar (sucrose) and HFCS both contain about equal parts glucose and fructose, just arranged differently. On its website, the FDA states:

“We are not aware of any evidence... that there is a difference in safety between foods containing HFCS and those containing similar amounts of other nutritive sweeteners like sucrose.”

Meanwhile, Robert F. Kennedy Jr., Trump's Secretary of the U.S. Department of Health and Human Services, has said that “sugar is poison” when referencing health risks supposedly posed by high-fructose corn syrup.

Kennedy also applauded news that fast-food chain Steak ’n Shake would begin offering Coca-Cola sweetened with real cane sugar instead of corn syrup, tweeting “MAHA is winning” to endorse his so-called “Make America Healthy Again” campaign.

However, the main advice from many nutrition industry experts is to limit added sugars in your diet, regardless of the type.

Will cane sugar Coca-Cola cost more?

Cane sugar generally costs 20% to 40% more than HFCS, according to U.S. Department of Agriculture (USDA) data.

As mentioned, the price difference largely stems from import restrictions, tariffs, and higher production costs for cane sugar compared to subsidized domestic corn used to make HFCS.

Recent data show refined cane sugar priced at over 50 cents per pound. That’s roughly 12% higher than high fructose corn syrup.

Some industry groups explain that cane sugar also requires more processing than HFCS.

For example, the Sugar Association reports that the crystallization and refining process from fibrous cane stalks is energy-demanding, while HFCS production, although complex, is less energy-intensive.

If Coca-Cola were to swap out HFCS for cane sugar even partially, that ingredient cost increase alone could potentially push soda prices up by around 10%. Additional expenses could come from production changes and supply chain adjustments.

Corn Refiners Association President and CEO John Bode said the following in a statement on the organization's website regarding potential product reformulations:

“Replacing high fructose corn syrup with cane sugar doesn’t make sense….[It] would cost thousands of American food manufacturing jobs, depress farm income, and boost imports of foreign sugar, all with no nutritional benefit.”

Note: Coca-Cola has not released specifics regarding the price of any potential cane sugar version of its popular soda in the U.S.

Soda tax adds another layer in some cities

Beyond ingredients, local soda taxes (also known as sweetened beverage taxes) in several U.S. cities, like Philadelphia, Seattle, and Chicago (Cook County), can also impact the total price you pay at the register.

These taxes typically add 1 to 2 cents per ounce or levy extra sales taxes on sugary beverages, regardless of whether sweetened with cane sugar or HFCS. And soda/sweetened beverage taxes don’t change based on which sweetener is listed on the label.

Supporters say city-level soda taxes help curb excessive sugar consumption due to health concerns, like obesity and diabetes.

• Data show that purchases of sugary beverages declined, on average 27% due to the levies.
• Additionally, some areas reported public health improvements, including weight loss, lower rates of tooth decay and improved pregnancy outcomes.

However, critics argue that soda taxes disproportionately impact working families.

Also, some studies suggest that soda taxes alone may not lead to substantial changes in body mass index (BMI) or obesity prevalence due to factors like consumer substitution to other unhealthy foods and broader lifestyle issues.

Notably, as of 2025, at least three states — Arizona, Michigan, and Washington — have passed laws that specifically ban local governments from imposing new soda taxes.

What all this means for soda lovers

President Trump’s call for cane sugar Coke has sparked some debate about U.S. soda preferences. While the sugar switch resonates with some, the real impact may be felt more in consumers’ wallets than on their taste buds.

Cane sugar tends to be more expensive and could lead to potentially higher costs for consumers. If your goal is health-conscious consumption, many experts say the key is to moderate overall sugar intake, regardless of the sweetener used.

Ultimately, knowing the different factors at play can help empower you to make informed decisions about the sweetened beverages you buy.

Regarding a new Coke product line, the company has suggested that it may be introduced this fall. Stay tuned.

Read More

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To help you understand what the U.S. is doing to address problems and challenges in the healthcare sector, our highly experienced Kiplinger Letter team will keep you abreast of the latest developments and forecasts (Get a free issue of The Kiplinger Letter or subscribe). You'll get all the latest news first by subscribing, but we will publish many (but not all) of the forecasts a few days afterward online. Here’s the latest…

Uncle Sam has made some progress in reducing cancer drug shortages by working with manufacturers to restart U.S. production facilities that were previously shut down, as well as securing vital overseas supplies.

One drug, cisplatin, often used to treat ovarian, bladder and testicular cancer has already returned to near 100% pre-shortage levels of supply. However, The U.S. still has an overall shortage of 15 cancer drugs, per the Food and Drug Administration (FDA), because of manufacturing and supply chain problems. 

In 2022, manufacturing site closures reduced the U.S. supply of cisplatin, (used to treat bladder cancer, testicular cancer, or ovarian cancer), carboplatin (used for ovarian cancer) and methotrexate (used for leukemia, breast and lung cancer, and more) by nearly half, leading to treatment delays for cancer patients. 

One survey by the National Comprehensive Cancer Network in June found that 70% of its members were experiencing a cisplatin shortage, while virtually all their members found carboplatin difficult to come by. Around 20% of cancer patients rely on platinum-based chemotherapy drugs, such as cisplatin and carboplatin, for treatment, according to federal health statistics.

Several U.S. manufacturers have exited this market in recent years, increasing American reliance on foreign imports from China and India, in particular. It remains unclear how Uncle Sam will address this long-term problem, which may ultimately require using government demand to bolster manufacturing.

One bill now under consideration by Congress, the Drug Shortage Prevention Act, would require manufacturers to report anticipated shortages ahead of time.

This forecast first appeared in The Kiplinger Letter, which has been running since 1923 and is a collection of concise weekly forecasts on business and economic trends, as well as what to expect from Washington, to help you understand what’s coming up to make the most of your investments and your money. Subscribe to The Kiplinger Letter.

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More than 600 million people worldwide suffer from osteoarthritis (OA), a debilitating joint disease that destroys mobility and quality of life. And for a long time, painkillers and corticosteroids were among the only “treatments” available for this joint-degrading disease.

Then Cytonics came along and developed a way to target the disease at the molecular level. 

Their flagship treatment, based on a naturally-occurring blood protein called Alpha-2-Macroglobulin, has treated over 8,000 people so far. Now, they are developing an even more potent and accessible version of it through FDA trials – opening their company to investors meanwhile (you can learn about Cytonics’ investment opportunity here).

Pharma has been desperately trying to develop a drug for osteoarthritis for the last 30 years, and has been unable to do so due to their poor understanding of the molecular underpinnings of the disease. Cytonics has solved this problem, which could mean a huge opportunity for investors. 

Cytonics Has Treated 8,000 Patients And Counting

This company has already built a strong track record thus far, starting with their FDA-approved Autologous Protease Inhibitor Concentrate (APIC) therapy. APIC is a device that purifies A2M from a patient’s blood, which can then be injected into the ailing joint. 

This was a breakthrough that proved the therapeutic power of A2M in treating cartilage damage in arthritic joints, and while they treated thousands with the APIC therapy, there were some kinks to iron out. APIC injections weren’t cost-effective enough to meet demand from millions struggling with the disease. Due to the fact that the A2M must be purified out of the patient’s blood, the procedure was also a long, tedious process for both doctors and patients. Also, there is patient-to-patient variability in the amount of A2M found in each individual’s bloodstream, meaning that the treatment could be more effective for some people than others. A simpler, more effective treatment that could be produced on an industrial scale and distributed globally was needed.

Cytonics rose to this challenge with the development of “CYT-108”, their genetically-modified, synthetic variant of A2M that is 4x more potent than the natural A2M found in blood. If approved by the FDA, CYT-108 will be capable of production on an industrial scale and global distribution as an “off-the-shelf” pharmaceutical that only requires a single injection and no blood preparation. 

Not only that, but CYT-108 has the potential to be the first and only “true” therapy for osteoarthritis that addresses the root cause of the disease instead of merely masking the symptoms. This will disrupt an enormous market that is growing as the global population rapidly ages and demands a higher quality of life. 

Cytonics’ $240B Market

As one of the largest generations enters retirement, 25% of adults in the U.S. are projected to suffer from osteoarthritis by 2030. 

But, believe it or not, this disease can affect just about anyone – old, young, active or not. Before Cytonics, these patients were spending $240B annually on painkillers and corticosteroids to treat the symptoms of their osteoarthritis. 

All of that money has the potential to move towards a real treatment for the disease that is affordable, accessible, and can actually stop the destruction of cartilage and promote regeneration. Cytonics achieving FDA approval for CYT-108 would be a big step in that direction.

Cytonics Is Getting Ready To Scale

The clinical and commercial success of Cytonics’ APIC therapy is a testament to the therapeutic power of A2M as a treatment for osteoarthritis. But the limitations of the APIC therapy necessitate a superior technology that overcomes the tedious nature of harvesting A2M from patients’ blood and provides patients with an off-the-shelf pharmaceutical that is highly potent and easily accessible. CYT-108 has the potential to do both. 

Instead of long appointments in doctors’ offices, patients could access an even more potent treatment directly from the pharmacy. Also, medical insurance payers will certainly take note of a therapy that reduces the need for total joint replacement, which will rapidly scale CYT-108 into the Medicare marketplace. 

With CYT-108 rapidly approaching the Phase 1 human study of the FDA-approval process, there is no better time to invest in Cytonics before they hit this next major milestone. 

Learn more about becoming a Cytonics shareholder here. 

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2024 will be here before we know it, and another big election cycle is on the horizon. Primary election years are usually strong for state-level cannabis legalization initiatives, given the higher voter turnout. We are closely watching a few key states, with potential weed legalization in Florida being of particular note. 

Late last week, we learned a key hurdle for recreational cannabis legalization in the state was cleared when Smart & Safe Florida gathered over 294,037 valid signatures for its petition. The committee is seeking weed legalization in Florida, and acquired the number of signatures needed for the Florida Supreme Court to review the proposal and confirm its validity. 

From there, the initiative will get the green light to continue gaining more signatures. It will require at least 891,589 for recreational cannabis use to make the ballot next year. Momentum is building, with key stakeholders like Trulieve (TCNNF) providing further funding, and Smart & Safe Florida is already around 33% of the way to gathering enough valid signatures to take recreational weed legalization efforts in Florida to the next step.

New York's recreational cannabis market flooded with counterfeit products 

The litany of issues regarding New York's emerging recreational cannabis market is well documented. Most recently, a report in Bloomberg detailed rampant illicit importing of cannabis from California and the nonchalant counterfeiting of these brands. This isn't new news per se, as NYC has had a regular flow of this type of activity for years. But it seems to be getting more attention as the state struggles to get legal recreational cannabis doors open. 

The market is facing a significant imbalance which is leading to consumer confusion and could introduce additional risks. 

"Consumer perception and industry standards don't always meld," said Maddie Scanlon of cannabis industry data firm Brightfield Group. "And you're like, 'Oh my god, they all are thinking they're shopping recreationally?' They just don't know." 

It's also fairly clear where the ball has been dropped. 

If state regulators cannot see the damage of bad governance and taxation, we expect the industry to step up to force a proper course correction. Each passing week of ongoing issues with escalating magnitude is harmful for the legal industry. We want to see the legal cannabis industry thrive, and we need the states like New York to recognize when they have done wrong and make fast, necessary changes. 

FDA delays decision on CBD regulations 

It's no surprise that the U.S. Food and Drug Administration (FDA) punted on cannabidiol (CBD), delaying its decision-making until forced by Congress. The FDA doesn't shoot from the hip regarding consumer safety. With the administration setting its own bar on science, it doesn't matter much what evidence outside researchers or the general public find compelling. 

Despite anecdotal and observational evidence, there is a need for more safety and efficacy data for the FDA to move forward on CBD. As a primary concern, the FDA has cited a lack of data on CBD's impacts on fertility, but one has to wonder if there was a problem would they not have acted already?  

Advocates and some industry insiders believe the next Farm Bill could be an upcoming moment for CBD. Unfortunately, considering the recent history of inclusion in must-pass legislation coming up short (SAFE Banking Act, anyone?), the cannabis and hemp/CBD industry must wonder if any material deviation from language already in the 2018 Farm Bill will make the cut. 

"The lack of traction that's gone over in the intervening years since the first farm bill, it's led us all to conclude that [CBD] isn't something [the FDA are] trying to work towards finding a pathway to regulate," said Michelle Bodian, partner at the cannabis-focused law firm Vicente Sederberg.

There is a large dietary supplement industry that wants CBD to be regulated as part of 1994's Dietary Supplement Health and Education Act, but GW Pharma's approved CBD drug complicates this. In addition, the FDA may be wise in avoiding a debate about the intoxicating derivatives of CBD rising in popularity.  

With the legislative and executive branches of the federal government letting the industry down, it may be time to pursue legal challenges en route to the Supreme Court. The upshot is that higher priorities may act to maintain the status quo for CBD on the federal level. This opens up an opportunity for states to work together and harmonize regulations that create a quasi-national legalization framework.  

One thing about cannabis and hemp is that every day the federal government fails to regulate these categories, the states deepen their ties to the industry and further shape the future for these products and consumers.

Little to no hangover effects from cannabis 

Wouldn't it be nice if you could come home after a day of work, relax with a legal wellness-like product, get a good night's sleep, and go to work the next day without a nagging hangover? Most cannabis users are very familiar with this dynamic. It's nothing new to us. We have experienced the ability to have a work-life balance without the hangover, but have been told that our experiences are just anecdotal. 

Thankfully, research continues to grow for the legal recreational cannabis industry, and a new study from the University of Sydney has emerged regarding marijuana and its "next-day" effects. The data shows little support for next-day effects and limited evidence of impairment the next day. 

The industry badly needs testing that can determine active versus inactive THC without the need to draw blood. For example, a saliva-based test would be far less intrusive and costly. We would like to see if a solution is underway, as that could boost continued legalization progress, especially among more conservative groups.

Starting Oct. 17, millions of Americans with mild or moderate hearing loss could save thousands of dollars because they no longer will be required to go through a medical professional to purchase a hearing aid. 

This means people may get their hearing aids in stores or online without first getting an exam from a doctor or an audiologist. Over-the-counter hearing aids will not be available for children or for adults with more serious hearing loss.

The Food and Drug Administration says close to 30 million adults could benefit from hearing aids, which the White House estimates cost an average of more than $5,000 a pair, and are often not covered by health insurance. Original Medicare, for example, does not cover hearing aids or the exams for fitting them. Officials say over-the-counter hearing aids should save consumers nearly $3,000 a pair.

A new FDA rule permits the sale of the over-the-counter aids that have previously received FDA clearance and are already being marketed by prescription. Any devices that have not previously been offered for sale must comply with new requirements issued by the FDA and must receive clearance before they can be brought to market.

Hearing Loss Advocates Welcome Change

Barbara Kelley, executive director of the Hearing Loss Association of America said the change is likely to make a difference for people with hearing issues. “We are hopeful that over-the-counter options will inspire some to take a first step to treat their hearing loss sooner,” Kelley said. “Ultimately this can mean a better quality of life, and avoiding the increased risk of dementia, falls and isolation associated with untreated hearing loss.”

According to the White House, only about 14% of the estimated 48 million Americans with hearing loss use hearing aids. At the same time, per Centers for Disease Control and Prevention, nearly half of Americans 60 and older suffer from hearing loss. Researchers at the World Health Organization say that age-related hearing loss is the “single greatest modifiable risk factor for dementia.”

Kelley noted that many consumers will still need treatment and advice from hearing-care professionals. “But opening more options is a big step in the right direction for a growing problem that affects one in seven Americans.” The association has a tip sheet giving detailed guidance, including questions to ask about over-the-counter hearing aids.

Congress Approved OTC Hearing Aids Five Years ago:

Over-the-counter hearing aids are the result of a law passed by Congress in 2017 and signed by then-President Trump. In July 2021, President Biden signed an executive order urging the FDA to enact the legislation. Today’s announcement is a final rulemaking that stems from these prior actions.

According to the FDA, the new rule allows over-the-counter sale of air-conduction hearing aids for people 18 and older with mild to moderate hearing loss. “A person with mild hearing loss may have difficulty hearing some speech sounds but not others,” the FDA says. “A person with moderate hearing loss may have increased difficulty hearing some speech sounds, even in a quiet room with someone talking at a normal level.”

Most hearing aids are considered air conduction, bringing amplified sound into the ear canal. Bone-conduction hearing aids, which will not be sold over the counter, are for people with problems with their outer or middle ear. These aids send sound through the skull to the inner ear.

Under the rule, over-the-counter hearing aids must allow users to adjust the volume. The rule also gives specifications for other performance and design requirements.

How to Know if Over-the-Counter May be Right for You

The National Institute on Deafness and Other Communication Disorders provides examples of issues experienced by people with mild to moderate hearing loss who may benefit from over-the-counter hearing aids:

• Speech or other sounds seem muffled.
• You have trouble hearing when you’re in a group, in a noisy area, on the phone, or when you can’t see who is talking.
• You have to ask others to speak more slowly or clearly, to talk louder, or to repeat what they said.
• You turn up the volume higher than what other people prefer when watching TV or listening to the radio or music.

When to See a Doctor for Hearing Issues

The Institute recommends seeing a physician if you have trouble hearing conversations in quiet settings or hearing loud sounds or if you experience any of the following issues:

• Pain or discomfort in your ear.
• A history of excessive ear wax or the sensation that something is in your ear canal.
• Episodes of vertigo (severe dizziness) with hearing loss.
• Sudden hearing loss or quickly worsening hearing loss.
• Hearing loss that has gotten more and then less severe within the last six months.
• Hearing loss or tinnitus (ringing) in only one ear, or a noticeable difference in how well you can hear in each ear.
• Fluid, pus, or blood coming out of your ear within the previous six months.

Seniors could see a cut in their monthly Medicare Part B premiums for 2022 after a controversial new drug’s price was slashed.

In November, Medicare set the monthly Part B premium at $170.10 for this year, a more than 14% increase from 2021. The agency said the increase was due in part to Medicare beneficiaries potentially being prescribed Aduhelm, an Alzheimer’s treatment manufactured by Biogen that was approved by the Food and Drug Administration last year. Since the drug must be administered by a physician, it is covered under Part B. Initially, the drug would cost $56,000 each year per patient, though Biogen later announced the price would be reduced to $28,200.

Health & Human Services Secretary Xavier Becerra said on Monday in a press release that he had asked Medicare to “reassess the recommendation for the 2022 Medicare Part B premium, given the dramatic price change of the Alzheimer’s Drug, Aduhelm.”

“With the 50% price drop of Aduhelm on January 1, there is a compelling basis for CMS to reexamine the previous recommendation,” he added.

The Kaiser Family Foundation estimated in June – before the drug’s price was cut – that if just a quarter of the 2 million Medicare beneficiaries who were prescribed an Alzheimer’s treatment under Part D in 2017 took Aduhelm, it would cost Medicare $29 billion in one year. Overall, Medicare spent $37 billion on all Part B drugs in 2019, according to KFF.

Besides the hefty price tag, experts have also raised concerns about the effectiveness and potential side effects of Aduhelm, leading Medicare to complete a national coverage determination to decide whether to pay for the treatment. On Tuesday, the agency issued a proposal that it would only cover the treatment for certain patients in clinical trials. Additionally, Medicare would limit coverage to patients who have the protein in their brain that Aduhelm is designed to target and have mild cognitive impairment or mild dementia.

The restrictions outlined in the proposal would likely limit the number of Medicare beneficiaries who can access the drug. The proposal, which can still be changed, is expected to be finalized later this year.

Medicare beneficiaries will pay more – a lot more – for Part B in 2022.

The Centers for Medicare & Medicaid Services said on Friday that the standard monthly Part B premium for next year will be $170.10. That’s an increase of 14.5%, or $21.60, from 2021. The annual Part B deductible will be $233, an increase of $30 from 2021.

The increases were due to rising health care costs and higher utilization of health care services, Medicare said. Congress also limited the Part B premium increase in 2021 -- premiums only rose $3 a month this year -- but Medicare now has to pay that back, starting in 2022.

Medicare beneficiaries potentially being prescribed the Alzheimer’s drug, Aduhelm, which was approved by the Food and Drug Administration earlier this year, was also to blame, Medicare said. Aduhelm’s price tag – $56,000 per person each year – has been criticized and has raised questions about the strain it would put on Medicare’s finances.

The Kaiser Family Foundation estimated in June that if just a quarter of the 2 million beneficiaries who were prescribed an Alzheimer’s treatment under Part D in 2017 took Aduhelm, it would cost Medicare $29 billion in one year. To put that into perspective, Medicare spent $37 billion on all Part B drugs in 2019, KFF said.

Since Aduhelm must be administered by a doctor, it is covered under Part B and not under a prescription drug plan. Medicare started a National Coverage Determination in July to determine whether and how the agency would cover the treatment and other similar Alzheimer’s drugs.

“While the outcome of the coverage determination is unknown, our projection in no way implies what the coverage determination will be, however, we must plan for the possibility of coverage for this high cost Alzheimer’s drug which could, if covered, result in significantly higher expenditures for the Medicare program,” Medicare said in a press release.

Single filers who make less than $91,000 in modified adjusted gross income (less than $182,000 for joint filers) will pay the standard Part B premium in 2022. They will also pay the standard premium for their Part D prescription drug coverage plan.

Beneficiaries who make more than those thresholds will pay a surcharge, called an income-related monthly adjustment amount, for Parts B and D. This applies to about 7% of enrollees for Part B and about 8% for Part D, Medicare said. Monthly Part B premiums for those hit with an IRMAA will range from $238.10 to $578.30, depending on the beneficiaries’ income.

As for Part D IRMAAs, beneficiaries will pay $12.40 to $77.90 per month in addition to their plan’s premium, depending on their income. In September, Medicare said the average premium for Part D for 2022 would be $33, up from $31.47 this year.

The Medicare Part A deductible for 2022 will be $1,556. That’s $72 higher than 2021. This covers the first 60 days of inpatient care at a hospital during a benefit period. After that, enrollees will pay $389 each day for days 61 to 90 during a hospital stay. That’s up from $371 in 2021. Beneficiaries will then pay $778 (up from $742 in 2021) per day for lifetime reserve days.

Enrollees will pay $194.50 per day in coinsurance for days 21 through 100 during a stay at a skilled nursing facility in 2022. That’s $9 more than what beneficiaries paid in 2021.

We all know that investing in biotech stocks isn't for the faint of heart.

They tend to be pretty volatile, experiencing massive price surges and slumps. The reason for all these swings is simple – biotech stocks trade on catalysts.

Unlike, say, a steady consumer products firm, biotech stocks march to the drum of regulatory approval, the outcomes of trial data and major conference presentations. Often, stocks in the sector will zoom higher or sink lower on these pieces of information.

Then it becomes a waiting game until the next major catalyst.

For investors looking to play in biotech stocks, knowing these important dates is vital for success. The worst thing to do is get caught off-guard and not have an exit strategy if things suddenly get ugly for your investment.

While the start of the calendar year is often prime time for U.S. Food and Drug Administration (FDA) events and trial data to be released, the summer also heats up for drugmakers and biotech stocks. The next few months feature several major events for a number of biotechnology firms and their shareholders.

The key is knowing which events to watch.

Finding Prescription Drug User Fee Act (PDUFA) dates – which are deadlines for the U.S. FDA to review a company's drugs – and other info for these biotech catalysts can be a daunting task. Here, we'll point out several of these dates for investors to mark on their calendars.

Here are eight biotech stocks with major catalysts on the calendar in the next few months.

Data is as of May 18. Note: Any dates listed here are tentative and subject to change.

• Market value: $146.5 billion
• Timeline to watch: September 2021

With its purchase of Celgene in late 2019, Bristol Myers Squibb (BMY, $65.60) became a biotech and cancer-fighting machine. BMY has top cancer drugs like Opdivo, Revlimid, Yervoy and Pomalyst under its umbrella, and its oncology drugs now account for roughly 66% of its total revenues – or more than $27 billion last year. Any catalysts that deal with BMY's cancer portfolio are paramount to its bottom line.

Many recent events for BMY have focused on its blockbuster drug Opdivo. The treatment has been a mixed bag lately, with overall sales falling 3% year-over-year to $1.7 billion in the first quarter of 2021. This follows a similar decline in fiscal 2020. Merck's (MRK) own wonder cancer drug Keytruda has taken much of Opdivo's thunder and has seen sales explode, jumping 19% year-over-year in the first quarter of 2021.

Drugmakers can often pick up incremental sales, push patent expiration and breathe new life into older drugs with expanded label coverage. With Opdivo sales falling as Keytruda gains more market share, pivoting the drug into other cancer-fighting uses is critical to BMY getting more sales into its coffers.

And with Keytruda sales rising fast, the biotech stock needs some major wins to keep the drug a powerhouse. It could get those this summer, with the FDA expected to issue a decision on using Opdivo as an adjuvant therapy in patients with muscle-invasive urothelial carcinoma by Sept. 3, 2021.

Guggenheim analyst Seamus Fernandez, who maintains a Buy rating on BMY, is upbeat about Opdivo sales. Physician checks that showed "solid early uptake" for the drug and the "combined use of Opdivo plus Yervoy and Opdivo plus Cabometyx will expand Opdivo sales significantly," he says. Because of this, Guggenheim estimates an additional $3.5 billion in Opdivo sales between 2025 and 2028, with revenue peaking at around $11 billion by the time the drug's patent expires in 2028.

• Market value: $132.6 billion
• Timeline to watch: August 2021

French drug giant Sanofi (SNY, $53.47) has been in the news lately for its COVID-19 efforts, reporting positive Phase 2 clinical trial data alongside GlaxoSmithKline (GSK). SNY is late to the vaccine party, though, and isn't projecting regulatory approval until at least the fourth quarter of 2021. However, there are other drug events on the calendar this summer that could serve as a catalyst for the biotech stock.

Chief of which is the FDA's Aug. 18 review date for Sanofi's avalglucosidase alfa, its enzyme replacement therapy (ERT) for Pompe disease. The review was initially scheduled for May 18, but was extended by three months.

Pompe disease is a rare genetic disorder that is caused when your body is unable to develop a protein that breaks down complex sugars called glycogen for energy. These sugars will then build up and eventually damage various organs and muscles. Typically, the disease affects children, but adults can get it as well.

Currently, there is no cure for Pompe disease, but there are treatments. Enzyme replacement therapy (ERT) is allowing doctors to basically inject the missing protein into a patient's body to break down the excess sugar. Sanofi owns the only ERT drug on the market, with FDA-approved Lumizym costing nearly $300,000 per year. (Lumizym is marketed as Myozyme in Europe.)

The second treatment set for review later this summer would be the new standard of care for Pompe disease and feature an advanced mechanism of action for getting the protein into muscles. The FDA already gave breakthrough therapy and fast-track designations to the drug last fall based on its trial data and need, which allows the company to hold patents for longer and move more quickly through the approval process.

While Sanofi has been hush on pricing for the new drug if approved, the firm pulled in $1.1 billion in sales from its ERT medications in 2020. Given that it's the world leader, another high-cost drug in its arsenal will boost those sales further.

• Market value: $3.5 billion
• Timeline to watch: June 2021

While its name might not sound familiar, Alkermes (ALKS, $21.88) is no slouch in the biotech world. The firm already markets two drugs in the U.S. – Aristada for schizophrenia and Vivitrol for alcohol and opioid addiction. Those drugs continue to work well for the firm. Revenues for the two drugs accounted for more than half of the $251 million in sales ALKS brought in during the first quarter.

On June 1, Alkermes could add another neurological drug to its umbrella.

After accepting Alkermes' resubmission of the New Drug Application for ALKS 3831 earlier this year – required due to the FDA's request last November that conditions at one of the company's facilities be resolved – the regulatory agency is expected to issue its decision on the treatment.

The drug is designed to treat adults that have been diagnosed with schizophrenia and bipolar I disorder. Featuring a new novel compound, ALKS could have another hit on its hand.

Analysts at research firm Prophecy Market Insights peg the global schizophrenia drug market to be worth around $9.8 billion in 2030 – up from $7.5 billion in 2020 – and ALKS could be positioned to take a piece of the pie. Given that the FDA committee addressed the safety and weight gain concerns in the resubmission, approval for ALKS 3831 seems imminent.

And while the approval would generate sales, the real win is the momentum it could provide ALKS throughout the year. The firm recently partnered with Merck for a combo-therapy using Keytruda to treat ovarian cancer and recent activist activity from Sarissa Capital Management helped drive the biotech stock up 18% last month.

Another FDA approval could help the biotech stock break out and reward shareholders.

• Market value: $467.1 million
• Timeline to watch: May 2021

One man's trash is another man's treasure. In the biotech world, that happens when one firm can't make a therapy work. Sometimes, they'll sell all the research and intellectual property (IP) rights for the drug on the cheap to another developer willing to pick up the pieces.

Which brings us to Provention Bio (PRVB, $7.37).

Back in 2010, Eli Lilly (LLY) – one of the largest global producers of insulin – and MacroGenics (MGNX) looked to team up to produce a type 1 diabetes medicine, Teplizumab. However, after Phase 3 trial data failed to meet the goals of the study, LLY shelved the project.

But in 2018, Provention picked up the drug on the cheap from MGNX and has been working to overcome some of the issues that it previously faced. That hasn't always gone to plan, however.

Earlier this year, an FDA committee meeting showed the regulatory agency found significant "deficiencies" between the pharmacokinetic and pharmacodynamic profiles generated by Eli Lilly and those manufactured by Provention Bio, and requested additional data.

Provention said this was due to the differences in contract manufacturers for the drug, but agreed to work closely with the FDA to "address its additional data requirement." On May 27, PRVB is expected to find out if an FDA advisory committee will recommend the approval of Teplizumab for the treatment of type 1 diabetes.

That could be a game changer.

For starters, the drug is designed to delay or prevent type 1 diabetes symptoms in certain at-risk individuals. That's huge and could upend the way we treat diabetes. It could also send billions into the young biotech's coffers.

Secondly, it's a make-or-break moment for Provention Bio itself. The firm had about $207 million in cash on its balance sheet at the end of the first quarter. If the FDA advisory committee recommends denying the application for Teplizumab, it will likely mean another round of costly trials for PRVB. The question is whether or not it has the cash to keep that going considering its other drugs in development stages.

While the biotech stock isn't an outright gamble, it is a risky one, given that the May PDUFA date is critical for Provention Bio's future.

• Market value: $2.1 billion
• Timeline to watch: June 2021

Women's health is one of the fastest growing market segments for drugmakers. For far too long, many women-specific health needs have gone unmet from drug manufacturers. That's been changing in recent years, with a variety of drugs being launched to cover these concerns. U.K. biotech stock Myovant Sciences (MYOV, $22.60) is one such firm.

The key to that focus is MYOV compound Relugolix. The drug has already been approved for treating certain prostate cancers. But the firm has been able to pivot the drug in certain combination therapies for other health needs. In this case, uterine fibroids.

It's estimated that more than 171 million women across the globe suffer from the non-cancerous tumors. And they're a big problem with heavy and prolonged menstrual bleeding, anemia and pelvic pain.

Right now, the treatment options are fairly limited, and include hysterectomies and progestin-releasing intrauterine devices (IUD). Myovant's treatment, on the other hand, is a non-invasive pill designed to shrink the fibroids. It faces some competition from a new drug from AbbVie (ABBV), but Myovant's entry could have a long runway for future growth and sales considering the market for treating uterine fibroids is still young.

Better still is that Relugolix has even more potential to shrink tumors. Myovant recently partnered with Pfizer (PFE) to run trials testing a combination of the drug for its contraceptive efficacy. Moreover, the compound is also seen as a treatment for endometriosis.

All of this kicks off for Myovant on June 1, when the FDA is expected to hand down its decision on using Relugolix to treat uterine fibroids – a ruling that could have an impact on the biotech stock.

• Market value: $42.3 billion
• Timeline to watch: June 2021

Truth be told, monster biotech Biogen (BIIB, $281.01) has had a long fight with Alzheimer's medications. The affliction is incredibly hard to fight and there currently are not any medications designed to really treat it.

BIIB hopes to change that, but the road has been bumpy.

Biogen originally stopped trials on aducanumab back in 2019 after early data suggested the drug would not "meet the primary endpoints." BIIB did a U-turn on the treatment later that year, saying it would submit it to the FDA after more trials. The bumps have continued to this day.

In November, an FDA advisory panel voted that they couldn't judge effectiveness of aducanumab based on the one trial submitted. Worse still was that several doctors in the FDA panel have expressed concerns about approving the potential Alzheimer's treatment through a Journal of the American Medical Association (JAMA) article.

The problem for Biogen is that it needs aducanumab approval to find growth over the long term.

Biogen does mint cash through its blockbuster multiple sclerosis (MS) drug, Tecfidera. Sales here clocked in at more than $2.6 billion last year. The issue is that new generic drugs are starting to eat away at Tecfidera revenues in a big way. Meanwhile, new MS treatments under Biogen's own umbrella, like Vumerity, have failed to live up to expectations. All in all, total revenues for BIIB slipped about 6% in 2020 versus 2019's numbers. BIIB already guided to lower revenues this year, as well.

Now, Biogen isn't in danger of going out of business. But without approval for the Alzheimer's drug, growth prospects could be limited for the near future. That's why the green light is so critical for the biotech stock on June 7, when the FDA decision on aducanumab is due.

• Market value: $55.6 billion
• Timeline to watch: June 2021

When it comes to cystic fibrosis (CF) treatments, Vertex Pharmaceuticals (VRTX, $214.65) is the leader hands down. Three of its FDA-approved drugs – Kalydeco, Orkambi, and Symdeko – are some of the top treatments for the disease. As such, they're cash cows and drive VRTX's hefty revenues. Last quarter alone, the drugmaker managed to record revenues of over $1.72 billion. That was a 14% increase versus the first quarter of 2020.

Now, Vertex has several other non-cystic fibrosis medications in the works. But CF treatments will drive the show until about 2030 when patents start to expire. VRTX has been successful in pivoting those medicines into new combo therapies and indications. Trikafta, for example, brought in more than $3.9 billion in first-year sales in 2020.

More sales could be on the horizon. On June 8, the FDA will rule on allowing Vertex to use Trikafta in children with cystic fibrosis ages 6 through 11 with certain mutations. Again, this is an untapped market that will allow VRTX to maintain its dominance in cystic fibrosis treatments. Better still, these are the sort of incremental sales that have contributed to VRTX's long-term earnings growth.

More importantly, the approval will provide Vertex with even more cash to fund its non-CF operations and development. And dare I say it, possibly pay a dividend, too. Last quarter, it ended with $6.9 billion in cash on its balance sheet.

In the end, adding another notch on its belt will allow Vertex to generate even more cash for shareholders – and potentially provide a boost for the biotech stock.

• Market value: $5.5 billion
• Timeline to watch: June 2021

Thinking "small" has allowed Blueprint Medicines (BPMC, $93.54) to win over the last year or so.

BPMC has focused its research on so-called small-molecule drugs. Unlike regular biologic therapies, small-molecule drugs are more stable. This allows them to be taken as pills rather than through injections. Most biologic drugs come in injectable forms and must be administered by a doctor, nurse or other medical professional. For those drugs that require ongoing and repeat doses, this can be a hassle for many patients.

Given this, small-molecule drugs offer better accessibility and ongoing treatments.

Blueprint Medicines has already scored two approvals – Gavreto and Ayvakit – for certain types of lung and stomach cancers. With the rarity of those cancers, price tags for the medicines are sky high.

Total revenues for BPMC's first quarter of 2021 came in at $21.6 million. While that may seem small, this is a huge 250% gain in sales versus the first quarter of 2020. Ayvakit drove the show, bringing in $7.1 million in net product revenue over the three-month period.

Which is why the additional approval of Ayvakit on June 16 could be a major winner for BPMC.

Blueprint Medicines is looking to use Ayvakit to treat advanced systemic mastocytosis (SM), which is a rare condition caused by the accumulation of mast cells in the body's organs. This leads to potentially debilitating and life-threatening symptoms.

Already, BPMC's treatment has received breakthrough designation status from the FDA. This would allow the company to hold patents for longer and move more quickly through the approval process.

It also could mean plenty of surging revenue. With Ayvakit already causing a major boost to Blueprint Medicines's sales in a short amount of time, any additional wins for the drug should be a windfall – and a positive catalyst for the biotech stock.

Aaron Levitt was long BMY as of this writing.

This is the time of year when stocks are sleepy at best, and at worst, prone to pullbacks.

That’s not necessarily true of all equities, however. Some groups are very active and perform quite well in the summer months. Pharmaceutical stocks – and especially biotech stocks – fare pretty well this time of year.

Part of that cyclical strength stems from how the Food and Drug Administration schedules key decision-making dates for new drugs. Another part of it may be the result of recurring industry conferences, where many drug-development updates are unveiled.

Here are 11 biotech stocks and pharmaceutical companies to watch over the next few months. Because biotechnology companies’ shares tend to hinge heavily on product updates, this seasonal tide of news could move their respective stocks well before (and even long after) the day the news is posted. Just be cautious; smaller biotechnology stocks with one or just a couple of trial products can move drastically on new data – for better or for worse.

Data is as of May 29.

• Market value: $27.2 billion

Neuromyelitis optica spectrum disorder (NMOSD) typically isn’t discussed outside of the circles of people directly impacted by it. Indeed, most people struggle to retain and even say its full name.

But that relative obscurity is also the root of its opportunity.

• Alexion Pharmaceuticals (ALXN, $121.30) is a specialty pharmaceuticals firm that is really coming into its own. Analysts expect sales growth of 15% this year, which should drive a 19% jump in profits to $9.46 per share. (2020 profits are forecast to hit $10.73.) ALXN even trades for a more-than-reasonable forward-looking price-to-earnings ratio of less than 12.

Alexion’s eculizumab – which is marketed as Soliris and already approved as a treatment for handful of mostly under-addressed ailments – has been and should continue to be a key part of that growth.

Sales of Soliris grew 20% year-over-year to $962 million in its most recent quarter. If it gets the green light as a means of treating NMOSD – the FDA has set an “action date” of June 28 – Leerink Partners analyst Geoffrey Porges believes that could add $500 million to $700 million in sales every year. For a company whose 2018 revenues totaled $4.1 billion, that’s a big number.

Neuromyelitis optica spectrum disorder, by the way, is an inflammatory disorder that can destroy the protection lining of optic nerves and the spinal cord. There’s no approved therapy for the condition, leaving the market entirely to Alexion if the FDA gives it the nod.

• Market value: $315.0 million (AMAG)/$280.2 million (Palatin)
• AMAG Pharmaceuticals (AMAG, $9.33) and Palatin Technologies (PTN, $1.38) have already been put off by the FDA once. However, assuming it doesn’t happen again, the companies will finally hear the agency’s final ruling on female sexual dysfunction treatment bremelanotide (marketed as Vyleesi) on June 23.

This has been a tricky one.

Sprout Pharmaceuticals brought Addyi – often called the “female Viagra” – to the market in 2015, and expectations were high. Sales of the drug never quite lived up to the hype, however. Options such as estrogen have been more utilized since then, but an actual “cure” remains elusive. Even abating the underlying symptoms has proven difficult.

Vyleesi could prove to be a success as a treatment for hypoactive sexual desire disorder (HSDD) where other options have fallen flat. Although the subcutaneous injection format still causes concern about its marketability, more than 90% of the women in the Phase 3 trial acknowledged the self-injection pen was acceptable to use. Better yet, the injection isn’t needed daily; it only needs to be administered before intercourse.

Peak annual sales estimates for Vyleesi currently vary from $800 million to $1 billion. That wouldn’t be noticeable at a Big Pharma firm, but even splitting that revenue equitably between AMAG and Palatin would offer a noticeable boost for both small-cap biotech stocks.

• Market value: $6.7 billion

Keep your eyes and ears open on June 14 for a Phase 3 trial update on Zynteglo (formerly LentiGlobin) as a treatment for transfusion-dependent β-thalassemia, a blood disorder. That’s when Bluebird Bio (BLUE, $122.25) will be presenting its most recent data on the drug at this year’s European Hematology Association Congress.

Thalassemia is a genetic disease that prevents the flow of oxygen in a human body by suppressing the functionality of hemoglobin. Its chief symptom is chronic anemia, though the condition can cause myriad other problems too. Transfusion-dependent β-thalassemia, or TDT, is a more severe form of the disease, also characterized by anemia, but also requiring constant blood transfusions. Even then, these patients can suffer from too much iron in the blood, and ultimately face shorter lifespans.

Zynteglo looks promising so far. In Phase 1/2 testing, the gene therapy was able to cut the sickling of red blood cells between 30% and 60%, which the company believes is statistically significant enough to suit regulators.

β-thalassemia isn’t a terribly common ailment, affecting only about one in every 100,000 people. It’s even rarer in the United States; it’s more commonly found in Asia and the Middle East. But it’s an underserved market, which typically translates into a sizable opportunity. Jefferies estimates that sales of Zynteglo as a thalassemia therapy could approach $700 million by 2026. If it’s also approved as a treatment for sickle cell disease, that peak revenue figure could exceed $1 billion.

For a biopharma company that doesn’t yet have a single product on the market, the EHA presentation could easily push its shares higher – or lower, depending on the outcome.

• Market value: $709.6 billion
• Intra-Cellular Therapies (ITCI, $12.87) isn’t a household name. With a market cap just above $700 million and no revenues to speak of, it’s unlikely many investors have heard of it. But a few have – and that number may start growing by the end of June.

ITCI has several trials underway, all of which are being updated on a pretty regular basis. Case in point: In late May, at this year’s American Psychiatric Association (APA) meeting, Intra-Cellular Therapies presented its most recent data from its trial of ITI-007, also called lumateperone, as a treatment for schizophrenia. The company still is working with a PDUFA date – a deadline under the Prescription Drug User Fee Act for the FDA to review a drug – of Sept. 27 for that particular trial’s indication.

But investors should get important news before that. Intra-Cellular Therapies confirmed in its first quarter report that it would offer an update of Studies 401 and 404 – both of which are tests of lumateperone as a treatment for bipolar depression – before the end of the current quarter. If all goes as well as hoped in this third stage of drug testing, ITCI says it expects to file for FDA approval during the second half of 2019.

That may well happen around the same time the FDA makes the call on the same drug as a treatment for schizophrenia.

• Market value: $204.3 billion
• Merck (MRK, $79.36) is a drug giant with a huge portfolio of marketable products, so one or even two more approved drugs likely would not make a meaningful impact on the stock’s price.

When the drug in question is Keytruda though, anything’s possible.

It’s been something of a wonder drug. Keytruda was first approved in September 2014 as a treatment for advanced melanoma in September. Since then, the anti-PD-1 antibody has been approved for 18 more indications. Although many of them are closely related conditions, the therapy has shown efficacy as a treatment of renal, gastric, cervical, and head and neck cancers, as well as a treatment of Hodgkin lymphoma and Merkel cell carcinoma. The PD-1 checkpoint pathway has proven a solid means of making sure cancerous cells are unable to “hide” from the body’s own immune system. As a result, Keytruda sales have exploded, hitting nearly $7.2 billion in 2018 alone.

Merck still is developing the drug, too. The FDA is mulling not one but two more drug approval requests for Keytruda. On June 10, the FDA will decide whether the drug is a fit first-line treatment for head and neck squamous cell carcinoma, and on June 17, the FDA will make its final call on Keytruda as a treatment of a different category of small cell lung cancer (SCLC) it’s not already approved for.

Neither is guaranteed approval. But the fact that the FDA has given both requests a priority review suggests the regulator isn’t thrilled with any existing treatment option for either indication.

• Market value: $196.9 billion

There’s no hard-and-fast date for Novartis AG (NVS, $85.81) to dish an update on its Phase 3 trial of secukinumab (better known as Cosentyx) as a treatment for psoriatic arthritis. In fact, technically speaking, the company didn’t even confirm it would announce the trial’s completion, or supply any color on its results if and when it did. Novartis only has said the trial would wrap up sometime during Q2 of this year.

It would be unusual if Novartis didn’t serve up some sort of press release on the matter, however, even if only to tell investors exactly when they may expect some more concrete information. And there’s only a month left in the organization’s touted timeframe.

Psoriatic arthritis is a relatively crowded arena. With roughly $12 billion worth of sales up for grabs treating a disease that is no longer all that tough to treat, most of the major names have put something on the table.

Cosentyx has a shot at becoming a standout in that crowded field.

Already approved as a treatment for plaque psoriasis and for psoriatic arthritis in patients that also suffer ankylosing spondylitis, the drug has proven itself safe. Now, Novartis thinks that the success of its first and only fully human inhibitor of the cytokine IL-17A (which can cause inflammation and bring on related diseases) for other indications can translate into a wider usage profile.

• Market value: $232.0 billion

So-called biologic drugs used to be less vulnerable to the loss of patent protection than more conventional, chemically formulated drugs. Even if a rival pharmaceutical company could replicate a production process using the living cells necessary to make more complex molecular structures, yielding a product comparable enough to the original to satisfy the FDA was historically a challenge.

Time, money and technological advances have changed that dynamic. Now, savvy biopharma outfits have become proficient at the science of making biologic drugs that are just as effective – even if not identical – to the original. Since the FDA approved the first one in 2015, a race of “biosimilars” has been underway.

• Pfizer (PFE, $41.72) is ready to write the next chapter of the biosimilar saga.

No firm date has been given for its biosimilar version of Genentech-made cancer treatment Avastin, but the FDA’s decision on bevacizumab’s safety and effectiveness (in other words, its similarity) is expected to come sometime during the second quarter. Pfizer has already planned to begin marketing the product as early as mid-July, presuming it will win the regulatory green light it needs.

Genentech has already filed a patent-violation lawsuit, of course. But such suits have mostly faltered thus far. They’re more often recognized by the courts as a means of disrupting potential competition rather than making a legitimate legal claim.

• Market value: $33.7 billion (Regeneron)/$101.9 billion (Sanofi)

Dupixent, also called dupilumab, has already been approved for multiple indications, including asthma and adolescent dermatitis. It’s best known as a therapy for eczema, though, which was its first and most important approved use.

Another big approval is on the table. Shareholders of co-developers Regeneron Pharmaceuticals (REGN, $307.78) and Sanofi (SNY, $40.82) may want to mark June 26 on their calendar, as that’s the day the FDA will make its final yea-or-nay decision on Dupixent as a treatment for nasal polyps.

It’s an admittedly obscure and non-life-threatening condition. Nasal polyps are, just as suggested, non-cancerous polyps that grow within the nasal cavity that can create a variety of nagging symptoms like postnasal drip, pain, uncomfortable pressure and even nosebleeds. Nasal polyps also are, unsurprisingly, often linked to asthma, immune disorders and allergies – other conditions that Dupixent has been approved to treat. If the symptoms and underlying causes go hand-in-hand, that bodes well for the drug’s chances in late June.

It’s not a big market; nasal polyps only affect about 10 million people in the U.S. But it’s an underserved market that Regeneron and Sanofi could readily control if they secure approval. And given that the drug as a nasal polyp treatment is under priority review, the FDA’s current bar is set relatively low.

The real upside is that nasal polyp patients could be introduced to a drug that also abates other conditions they may already suffer from, and vice versa.

• Market value: $310.9 million
• Xeris Pharmaceuticals (XERS, $11.54) isn’t exactly among the most well-known of biotech stocks, but June 10 could be a day that puts the small-cap company on more investors’ radars. That’s when the FDA is scheduled to make its final decision on the company’s glucagon rescue pen for sufferers of severe hypoglycemia in people with diabetes.

Hypoglycemia is, in simplest terms, low levels of blood sugar. While it’s not the only cause of the condition, treating diabetes – the inability to keep blood sugar in check – can sometimes cause hypoglycemia.

It’s not exactly a new idea. Novo Nordisk (NVO) and Eli Lilly (LLY) have had such pens on the market for several years. Xeris’ so-called G-Pen, however, has an advantage on other pens already available to individuals that may experience symptoms such as heart palpitations, anxiety and shakiness due to their hypoglycemic condition. The glucagon formulation being utilized by Xeris Pharmaceuticals is stable and usable as-is, so it doesn’t require the pre-use mixing that alternative pens do. It’s easier and faster for individuals to use when speed and simplicity matter the most.

Although the expected June 10 decision on the G-Pen is narrowly focused on a small subset of the hypoglycemia, the company isn’t limiting its options to just that piece of the market. A Phase 2 trial of the same treatment for exercise-induced hypoglycemia is already underway, potentially widening its approved uses.

Stephen Moore began to realize he had hearing problems more than a decade ago, when people seemed to mumble in conversations. He asked his wife to repeat lines at the movies. "It drove her crazy," he says. He turned the TV volume up so high that family members complained.

Finally, when he felt he was missing out on hearing important details during meetings at work, he got his hearing tested and was then fitted for hearing aids.

"Hearing loss is so gradual you don't really recognize it until your hearing is impaired, and it gets really bad," says Moore, 57, an economist for the Heritage Foundation, a conservative think tank, who also works as a TV analyst. "And there's still a little bit of a stigma about wearing hearing aids."

As people age, they often don't immediately recognize hearing decline or seek treatment for it, says Barbara Kelley, executive director of the Hearing Loss Association of America. It takes an average of seven to 10 years from the time someone recognizes he or she has a hearing loss until getting help for it, she says. And about 80% of adults who could benefit from a hearing aid don't get one, according to a report by the National Academies of Sciences, Engineering and Medicine.

Does Medicare Cover Hearing Aids?

Baby boomers are sometimes reluctant to take even the first step of getting a hearing test, seeing it as a sign of aging and fearing having to wear "that brown plastic thing behind your ear," Kelley says. Not to mention that hearing aids can be expensive, as much as $3,000 per ear, and aren't covered by Medicare and only sometimes by other insurance.

So it was good news for people with hearing loss when Congress last August authorized the Food and Drug Administration to create a new class of hearing devices, which will be available over the counter and expected to cost far less than what you pay for a device from the audiologist's office. The over-the-counter hearing aids are for adults with mild to moderate hearing loss and will be FDA-regulated. The only way now to purchase a hearing aid is through an audiologist or hearing instrument specialist. In the future, certain hearing aids and other hearing wearable devices will be available in pharmacies and electronics retailers.

What's often confusing, though, is that some over-the-counter alternatives, sometimes called personal sound amplification products, are available in stores now. Moore, for example, once grabbed a cheap pair when he lost his regular hearing aids on a trip. Quality and prices for the devices vary widely; some disposables sell for $20 to $30 per pair while high-tech sound amplifiers cost several hundred dollars.

But these devices aren't considered medical devices or regulated by the FDA, and they can't be marketed as hearing aids or as a product to improve hearing loss, even with the new law. The FDA has up to three years to write regulations and set safety and labeling standards for the authorized OTC devices. An FDA spokesperson said the agency won't speculate on a time frame for the process. Once regulations are in place, expect lower prices for FDA-approved aids and more choices.

Getting Your Hearing Tested

Don't wait to address your hearing health as the guidance is sorted out. Get tested by an audiologist, take an online screening test, or visit a hearing center that has licensed hearing health providers. Find a hearing aids guide at hearingloss.org.

Take advantage of hearing aid discounts. Costco offers its own brand of hearing aids and other hearing services. Drugstore chain CVS has opened 32 hearing centers in seven states, with plans to expand this year, a company spokesperson says. Single device costs range from about $400 to $2,500. Try a high-tech device that's not a hearing aid. Hearing technology company Nuheara sells wireless earbuds that work with a smartphone app for about $300 a pair. Wearers can tune out background noise at restaurants, offices or outside and "control how they hear the world around them,' says company co-founder David Cannington.

Do You Need a Hearing Aid?

The following are some signs of when to consider having your hearing tested, according to the Food & Drug Administration:

• You hear better out of one ear than the other.
• People say you are shouting when you talk.
• You often ask people to repeat themselves.
• You can’t hear a dripping faucet or high-pitched musical notes.

The pharmaceutical industry occasionally hits a home run by creating a drug that generates sales in excess of $1 billion per year – the watermark for what constitutes a so-called “blockbuster.” These heavy-hitters are a rarity relative to the number of drugs that begin development but never really go anywhere. But the proverbial whale hunt for blockbuster drugs continues because some of these therapies can end up being worth tens of billions of dollars during their useful, patent-protected lives.

No investor owns a crystal ball, of course. Ergo, no investor can truly predict how well a new drug may sell if it gains approval from the FDA or overseas regulatory bodies.

But because it takes years to develop a drug – and because most pharmaceuticals are largely variations of previously approved therapies – analysts and industry experts have the time and means to figure out what kind of potential revenue a new drug may drive.

Here’s a run-down of the pharmaceutical market’s top 10 prospects currently in late-stage testing. While their respective approvals aren’t guaranteed, the pros feel pretty good about their odds. (Good enough to start creating revenue outlooks, anyway.) All are projected to become so-called blockbuster drugs, driving more than $1 billion in annual revenue at their projected peak sales and potentially providing a boost to their creators’ stock prices.

Data is as of Nov. 29, 2017. Click on ticker-symbol links in each slide for current share prices and more.

• Company: Eli Lilly
• Treats: Breast cancer

Verzenio, a therapy from Eli Lilly (LLY, $84.96) that was developed under the name abemaciclib, was approved in October for certain types of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-negative) breast cancer.

It’s not done yet. While Verzenio recently failed a Phase 3 trial as a treatment for non-small lung cancer, Lilly announced in early November that the drug had been given a priority review status for other forms of metastatic breast cancer. Even more applications could be in the cards above and beyond the ones already on the table.

Bernstein analysts expect Verzenio to generate $1.3 billion in sales by 2021. While some competition already exists in the drug’s most plausible markets, Bernstein’s Tim Anderson wrote earlier this year that the drug can “produce more frequent and more durable tumor responses that translate to longer (progression-free survival).”

Now it’s just a question of how well Eli Lilly markets that differentiation.

• Company: Incyte
• Treats: Lung cancer

Epacadostat is a cancer drug currently being developed by Incyte (INCY, $95.96). In simplest terms, the treatment alters tumor cells in such a way that allows the body’s own immune system to do what it’s supposed to do, but can’t do in some cases.

It's not epacadostat by itself that's so promising, however. The oncology world – and investors – are buzzing about epacadostat when used in conjunction with cancer-fighting treatment Keytruda from Merck (MRK) as a treatment for lung cancer. When used at the same time, the two drugs double the response rate of Keytruda by itself. Perhaps best of all, the response was consistent regardless of PD-L1 levels – one of the oncology drug industry’s newest “hot buttons.”

The flexibility and success bode well for all eight trials evaluating the drug, but it is worth noting that all trials are early-stage efforts. Still, analysts collectively think epacadostat could drive revenues of up to $1.6 billion per year if its most plausible approvals pan out.

• Company: Novo Nordisk
• Treats: Diabetes

Semaglutide may be difficult to pronounce, but its potential is easy to understand. The once-per-week injection invented by Novo Nordisk (NVO, $51.32) lowers blood sugar levels by increasing a body’s production of insulin, which makes it a great prospect for the war against diabetes, and type 2 diabetes in particular. As Novo Nordisk’s Chief Medical Officer Todd Hobbs explained last month, “Semaglutide has the potential to impact the lives of people with type 2 diabetes by helping to meaningfully reduce A1c. This treatment option may also help people lose weight. We look forward to continuing to work with the FDA as they complete their review of semaglutide.”

The last leg of that review is underway. In October, an FDA advisory panel 16-0 (with one abstention) to recommend approval of the product, which would be marketed as Ozempic. The agency is scheduled to make its final decision on semaglutide on Dec. 5. (EDITOR'S NOTE: The FDA approved the treatment after this writing.)

The treatment’s estimated prospects vary widely, with the mean sitting just above $3 billion in annual sales. Alm Brand Bank analyst Michael Friis Jorgensen’s is more optimistic, with a peak-sales estimate of between $4.6 billion and $5.3 billion.

Semaglutide poses the biggest threat to Eli Lilly's Trulicity. Bernstein analyst Ronny Gal opined in August when the drug’s final trial results were first disclosed, “Novo will now be in a strong position when discussing semaglutide with payers, having demonstrated superiority vs. the competition and also the added CV (cardiovascular) benefit, which Lilly has yet to do.”

• Company: Gilead Sciences
• Treats: Non-Hodgkin lymphoma

When Gilead Sciences (GILD, $73.67) acquired Kite Pharma in October, it primarily was to get its hands on Kite’s CAR-T cell cancer therapy pipeline, most of which essentially reprograms a patient’s immune system to better fight cancer. Of particular interest was axicabtagene ciloleucel (axi-cel), which has shown incredibly efficacy as a therapy for aggressive B-cell non-Hodgkin lymphoma. On average, analysts believe the drug could drive $1.7 billion worth of annual business by 2022. RBC analyst Brian Abrahams thinks peak sales could be $2.7 billion.

Good news on that front. Axi-cel, which has since been renamed Yescarta, was approved by the FDA for that use on Oct. 18. It’s the first CAR-T cell therapy to earn the green light for that indication.

The drug’s potential for that form of cancer bodes well for Gilead, but the excitement doesn't end there. The same drug is in trials as a treatment for mediastinal B-cell lymphoma, follicular lymphoma and multiple myeloma. In the meantime, Kite has similar CAR-T drugs in the pipeline that are relatively close cousins to Yescarta.

• Company: Gilead Sciences
• Treats: HIV

As compelling as Kite’s Yescarta is, don’t overlook some of Gilead’s home-grown products. That includes Bictegravir – a treatment for HIV when it’s used in conjunction with existing HIV treatments emtricitabine and tenofovir alafenamide. The combo treatment's name has been shortened to BIC/FTC/TAF.

Bictegravir’s development journey hasn’t been an easy one. While hopes were high for the integrase inhibitor, in May the company released trial results suggesting it wasn’t quite the threat to GlaxoSmithKline's (GSK) Tivicay that it was alleged to be.

Still, the drug is showing respectable and even superior efficacy for some segments of HIV-infected patients when used as part of a combination therapy. The analyst community projects peak annual sales potential of $5 billion for the combo.

• Company: Celgene
• Treats: Multiple sclerosis

There’s no other way to put it: Analysts love the potential of Celgene’s (CELG, $103.12) multiple sclerosis drug ozanimod.

Leerink Geoffrey Porges opined following the recent release of Phase 3 trial results, “This product, along with luspatercept (an anemia treatment), has become the standard bearer for Celgene’s late stage pipeline, and in our view the data at the meeting justify some recovery in sentiment about the company’s portfolio and outlook.” Jefferies analyst Michael Yee deemed it a “best-in-class“ drug.

Ozanimod may be more than just an MS treatment. It’s also showing promise as a treatment for inflammatory bowel disease, and if approved for both indications, Porges thinks it could grow its annual revenue to as much as $2.9 billion by the year 2022.

Celgene is expected to officially file an FDA approval request for ozanimod before the end of this year.

• Company: AbbVie
• Treats: Endometrosis, uterine fibroids
• AbbVie’s (ABBV, $95.82) elagolix has not yet been approved as a treatment for endometriosis – a condition where the female uterus grows abnormally (and usually painfully). However, the FDA gave it a priority review timeline in October. That bodes well for AbbVie, as it indicates the regulator realizes there’s nothing on the market right now that meaningfully treats the condition.

Elagolix is not just a therapy for endometriosis, though. The drug also is in Phase 3 trials as a treatment for uterine fibroids, or noncancerous growths in and around the uterus.

The fibroids opportunity may be bigger than the endometriosis opportunity. Investment research outfit Zacks is pegging peak sales of Elagolix as a treatment for uterine fibroids at $2.6 billion, while saying its annual sales as a therapy for endometriosis could reach $1.5 billion.

• Company: AstraZeneca
• Treats: Lymphoma
• AstraZeneca (AZN, $33.32) is in desperate need of some growth, and lymphoma drug acalabrutinib may well provide some for the beleaguered company.

Acalabrutinib, which has since been given the trade name Calquence, won FDA approval late last month as a means of treating mantle cell lymphoma patients who were not responding well to first-line treatment options. The BTK inhibitor demonstrated a complete response rate of 40% in trials of qualified test patients, while another 40% saw a partial response to Calquence.

Calquence became part of the AstraZeneca family in 2015 when the company acquired a major stake in Acerta just to gain control of the drug. CEO Pascal Soriot believed then that the drug could generate as much as $5 billion in annual revenue, though after a few roadblocks, the market has since tempered its expectations.

However, some analysts still expect Calquence to generate $1 billion in annual sales, qualifying it as a blockbuster drug.

• Company: Johnson & Johnson
• Treats: Prostrate cancer
• Johnson & Johnson (JNJ, $139.81) subsidiary Janssen submitted its new drug application for prostate cancer drug apalutamide in late October, which tentatively means a decision should be made around the middle of 2018.

Prostate cancer treatments are a crowded $7.9 billion market, led by generic drugs like docetaxel, Jevtana from Sanofi-Aventis and Xtandi from Astellas, just to name a few. Apalutamide has something of an edge, however, when it comes to treating prostate cancer. The androgen receptor inhibitor is, as Janssen’s Peter Lebowitz described, “a new approach to treating men with prostate cancer earlier in the disease course.” He added, “We have demonstrated that treating patients before the disease has metastasized improves outcomes.”

Janssen has yet to share specific efficacy numbers of the latest stage of its testing, but that has not prevented EP Vantage analysts from predicting peak sales of $1.4 billion by 2022.

• Company: BioMarin Pharmaceutical
• Treats: Hemophilia

In 2016, when Evercore ISI clients were shown the results of trials of BioMarin Pharmaceutical (BMRN, $83.27) hemophilia drug valoctocogene roxaparvovec (formerly BMN 270), Evercore analyst John Scotti observed, “When they started presenting (the data), jaws just went to the floor. There was an audible gasp in the room.”

The description was a tad theatrical, to be sure, but the point stands: The treatment was the first successful gene therapy for the disease, and it worked very, very well. Indeed, there’s nothing out there quite like it. Leerink analyst Joseph Schwartz described it as a “one and done” treatment.

The total hemophilia market will be worth an estimated $25.1 billion by 2024, as the understanding of the disease increases and the diagnosis of it improves. The hemophilia A market, where valoctocogene roxaparvovec is aimed, is a $4 billion opportunity.

James Brumley held a long position in GILD as of this writing.

When a stock costs less than dinner at a fast-food joint, there’s almost always a reason. The company may be losing money, experimenting with unproven technology or have its future riding on the outcome of a hard-to-predict event. Or it may just be tiny. All that said, dabbling in stocks with single-digit prices can also be like putting a few bucks on red or black at a roulette wheel—you’ve got a roughly 50-50 chance that a small investment could deliver a big reward.

Share prices are as of November 17, 2014; revenues are for the last 12 months.

• Headquarters: TorontoShare price: $6.63Market capitalization: $78 millionAnnual revenues: $0
• Aptose Biosciences (APTO), which has yet to ring up a single sale, is one such company worth considering because it has a drug that appears to cause apoptosis—cell suicide. Unlike the result of necrosis—the killing of living cells—cell suicide causes no damage to surrounding cells and organs. The apoptosis process even causes the dying cell to send out signals for the body to clean up the resulting mess.

Development of innovative treatments has given life to dozens of little biotechnology companies that aim to attack various types of cancer. They do so by either stimulating patients’ immune systems; blocking the pathways that allow the disease to spread; or finding unique ways to tag cancer cells so treatments can zero in on the errant cells, without causing great damage to the rest of the body.

Aptose’s drug is still in the early stages of clinical testing, but Canaccord Genuity analyst John Newman thinks it has a good chance of being effective in treating acute myeloid leukemia. Positive results even in early-stage testing could propel the stock upward, he says. If approved, Aptose’s product could eventually generate annual sales of $300 million in the U.S., he adds. He thinks the stock will reach $13 within a year and could go far if the Food and Drug Administration approves Aptose’s drug.

• Headquarters: Victoria, British ColumbiaShare price: $3.50Market capitalization: $110 millionAnnual revenues: $920,000

The body’s immune system typically protects you from disease by finding, attacking and expelling foreign elements. But the process that works wonders for someone with the flu is a killer when you’ve received a kidney transplant or have an overactive immune system that keeps itself busy by attacking healthy tissue. A small biotech company called Aurinia Pharmaceuticals (AUPH) has developed an immune-system suppressant, called Voclosporin, that has been proven effective in keeping the immune system from rejecting a transplanted kidney, says John Newman, a biotechnology analyst at Canaccord. The company is now testing the drug for its ability to treat lupus nephritis, a disorder characterized by a hyperactive immune system that ultimately attacks the patient’s healthy kidneys.

The FDA has approved no new treatment for lupus nephritis in 50 years. But because Voclosporin has proved safe in treating other ailments, Newman is confident that the drug will sail through its next phase of testing and ultimately ring up $630 million in annual sales. Newman thinks the stock will start to move even before the drug gets final approval and that the share price could triple over the next few years.

• Headquarters: ChicagoShare price: $7.57Market capitalization: $5.0 billionAnnual revenues: $3.0 billion
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Owning shares of Groupon (GRPN) since the daily deal provider went public in November 2011 has been anything but a good deal. The stock has sunk 73% from the initial offering price. But Sterne Agee analyst Arvind Bhatia thinks that’s about to change as Groupon shifts from “push” to “pull” sales by training consumers to come to its Web site to look for deals. About 10% of Groupon’s sales come from consumers who have actively searched for deals and landed at the Web site. Those customers typically spend 50% more than those who were pulled in by an e-mail, Bhatia says.

Sure, Groupon has plenty of competition, with the likes of Amazon.com (AMZN), LivingSocial and others peddling discounted deals on a wide array of goods and services. But Bhatia thinks Groupon’s ability to pull 150 million unique visitors to its Web site each month differentiates the company from the pack and makes Groupon a compelling way for small businesses to market their wares. Though the company is still posting net losses, operating earnings turned positive in the second quarter of 2014, and Groupon is expected to report operating profits of five cents per share for the year. Operating earnings are expected to jump to 15 cents per share in 2015, an astounding 200% rise. But, that, of course is off a low base. Still, the company’s potential is great enough that Bhatia predicts that the stock will sell for $12 within a year.

• Headquarters: San DiegoShare price: $5.14Market capitalization: $297 millionAnnual revenues: $882 million

You may never have heard of Kratos Defense and Security Solutions (KTOS), a midsize defense contractor that makes electronic components used in drones, missiles, fighter jets and radar systems. What makes the business especially attractive is that Kratos works on “long-tail” jobs that can last decades, says Michael Crawford, an analyst with the Los Angeles investment banking firm of B. Riley & Co. As a result, even if future defense spending falls or grows at only a tepid pace, Kratos’s revenues are unlikely to drop precipitously. Another plus is that Kratos’s products are on the small and comparatively affordable side.

Kratos is in the process of refinancing and paying down the debt it took on when it bought three other defense contractors over the course of just a few years. Cleaning up the debt is likely to provide a big boost to earnings, which dropped sharply in 2014, and make Kratos an attractive acquisition target for bigger military contractors. But Crawford thinks the stock is a buy regardless of whether Kratos becomes a takeover target. He sees the shares reaching $9.50 within a year.

• Headquarters: Jacksonville, Fla.Share price: $1.11Market capitalization: $107 millionAnnual revenues: $0

In October 2013, a tiny semiconductor company called ParkerVision (PRKR) appeared to deliver a body blow to Qualcomm (QCOM), the giant chip maker whose technology is used in most of the world’s mobile phones. ParkerVision filed a lawsuit claiming that Qualcomm had stolen its patented technology for use in making the tiny chips that allow mobile phones to pull in data from nearby cell towers. A jury awarded ParkerVision, which doesn’t make anything but hopes to enforce its patents, a $173 million windfall. Several months later, a district court judge overturned the ruling, saying the jury didn’t have enough evidence to come to its conclusion. Now ParkerVision’s fate is riding on the appeal, as well as several other lawsuits against Samsung and other phone makers alleging similar infringements.

Getting those suits to pay off may sound like a long shot. But Ladenburg Thalmann analyst Jon Hickman believes that ParkerVision’s claim is strong and that the company should prevail on appeal. He thinks ParkerVision will also likely strike licensing deals with several other companies that have allegedly been using the company’s technology.

If he’s right, ParkerVision could leap from a company that generates no revenues to one that reports hundreds of millions in licensing fees annually. To be sure, basing an investment on the outcome of litigation is a gamble. But Hickman is confident enough in his analysis to place a one-year target price of $5 on ParkerVision’s stock, which would be a huge leap from its current value. However, if the lawsuits and licensing agreements don’t pan out, Hickman says, ParkerVision’s future could be in jeopardy.

• Headquarters: Camp Hill, Pa.Share price: $5.46Market capitalization: $5.3 billionAnnual revenues: $25.9 billion
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Launched as a mom-and-pop drugstore in the 1960s, Rite Aid (RAD) has grown into the nation’s third-largest pharmacy chain. But the company has been troubled since 2000, when an accounting scandal resulted in the imprisonment of several Rite Aid executives. New managers took over and expanded the company’s reach through a series of major acquisitions, but the buying spree left Rite Aid heavily in debt.

After flirting with extinction during the Great Recession, Rite Aid began to jettison poorly performing stores, remodel surviving locations and pay down debt. Analyst Ross Muken, of Evercore ISI, a New York City investment banking firm, says this restructuring is the basis of a comeback story that’s just getting started. Remodeled stores are attracting more customers. Also boosting results is an increased emphasis on wooing seniors with generic drugs and discount plans. Thanks to these developments, analysts expect Rite Aid’s earnings to soar 31%, to 38 cents per share, in the fiscal year that ends in February 2016. That’s on top of a 26% gain in the current year. Muken thinks the stock will be worth $6 within a year, but shareholders will benefit the most by taking a long-term approach to riding Rite Aid’s recovery.

• Headquarters: New York CityShare price: $3.52Market capitalization: $19.4 billionAnnual revenues: $4.1 billion

The only thing tiny about Sirius XM Holdings (SIRI), the satellite radio company, is its stock price. In early 2000, as the dot-com craze was about to end, Sirius shares soared to $61. But the stock has been trading in single-digit territory for the past dozen years.

Sirius’s revenues have grown at a blistering 51% annualized rate over the past 10 years. And the company, which has been around since 1990, finally turned profitable in 2010. The stock, though, has been meandering since Liberty Media, which owns 53% of Sirius, early this year scuttled its plan to buy the rest of the company’s outstanding shares.

The key to future growth is new-car sales, says analyst James Goss, of Barrington Research, a Chicago-based investment bank. Roughly 70% of the cars sold in the U.S. now have Sirius technology built in, and buyers of new vehicles get a free trial to sample Sirius’s commercial-free radio content. Four in 10 drivers agree to subscribe once the trial is over, Goss says. That gives the company a steady, annuity-like stream of income.

To be sure, the rapid revenue growth Sirius has enjoyed is unlikely to continue as the company gets bigger. But between share buybacks and continued subscriber growth, analysts expect the company’s earnings to jump 50% in 2015, to 12 cents per share. The Value Line Investment Survey says Sirius shares have “wide” capital appreciation potential over the next few years, making them appealing to “speculative investors.”