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July 15, 2026 07:00 ET  | Source: Axsome Therapeutics, Inc.

FDA sets PDUFA target action date of May 1, 2027

NEW YORK, July 15, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s New Drug Application (NDA) for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027. The FDA also indicated that it does not currently plan to hold an advisory committee meeting to discuss the application.

About Narcolepsy

Narcolepsy is a serious and debilitating orphan neurological condition that causes dysregulation of the sleep-wake cycle and is characterized clinically by excessive daytime sleepiness, cataplexy, hypnagogic hallucinations, sleep paralysis, and disrupted nocturnal sleep.1-3 Cataplexy is seen in an estimated 70% of narcolepsy patients and is a sudden reduction or loss of muscle tone while a patient is awake, typically triggered by strong emotions such as laughter, fear, anger, stress, or excitement.4-5 Narcolepsy is a life-long condition that interferes with cognitive, psychological, and social functioning, increases the risk of work- and driving-related accidents, and is associated with a 1.5-fold higher mortality rate.6-8

About AXS-12

AXS-12 (reboxetine) is a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator under development for the treatment of narcolepsy. AXS-12 is thought to modulate noradrenergic activity to maintain muscle tone during wakefulness, and noradrenergic and cortical dopaminergic signaling to promote wakefulness and cognition function. AXS-12 has been granted U.S. Food and Drug Administration (FDA) Orphan Drug Designation for the treatment of narcolepsy. AXS-12 is not approved by the FDA.

About Axsome Therapeutics

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.

Forward Looking Statements

Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company’s ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

Investors:

Ashley Dong
Senior Director, Investor Relations
(929) 687-1614
[email protected]

Media:
Darren Opland
Senior Director, Corporate Communications
(929) 837-1065
[email protected]

References

American Academy of Sleep Medicine. The International Classification of Sleep Disorders. Third Edition (ICSD-3). 2014.National Institute of Neurological Disorders and Stroke. Narcolepsy. https://www.ninds.nih.gov/health-information/disorders/narcolepsy. Accessed September 2024.España RA, Scammell TE. Sleep neurobiology from a clinical perspective. Sleep. 2011 Jul 1;34(7):845-58.Narcolepsy Network. About Narcolepsy. https://narcolepsynetwork.org/about-narcolepsy/. Accessed September 2024.Swick TJ. Treatment paradigms for cataplexy in narcolepsy: past, present, and future. Nat Sci Sleep. 2015 Dec 11;7:159-69.Tadrous R, O'Rourke D, Mockler D, Broderick J. Health-related quality of life in narcolepsy: A systematic review and meta-analysis. J Sleep Res. 2021 Dec;30(6):e13383.Patil SP, Ayappa IA, Caples SM, Kimoff RJ, Patel SR, Harrod CG. Treatment of Adult Obstructive Sleep Apnea With Positive Airway Pressure: An American Academy of Sleep Medicine Systematic Review, Meta-Analysis, and GRADE Assessment. J Clin Sleep Med. 2019 Feb 15;15(2):301-334.Ohayon MM, Black J, Lai C, Eller M, Guinta D, Bhattacharyya A. Increased mortality in narcolepsy. Sleep. 2014 Mar 1;37(3):439-44.

Axsome Therapeutics (AXSM 1.68%) and Revolution Medicines (RVMD 0.36%) have offered investors significant growth so far this year. The biotech companies saw their shares soar 34% and 135%, respectively, in the first half. This may have happened as investors, seeking growth beyond the popular theme of artificial intelligence (AI), looked to biotech innovators -- companies with newly launched products or exciting progress in clinical development.

Axsome and Revolution have been stocks to watch in these areas. Axsome has won approval for two products rather recently, and Revolution has announced fantastic phase 3 results for its lead oncology candidate -- one that could transform the treatment of certain cancers. These stocks both make solid buys for an investor looking for growth in the healthcare space. But if you could only buy one, which one should you choose? Let's find out.

Image source: Getty Images.

The case for Axsome Axsome is a specialist in central nervous system disorders, and the company already has three products on the market -- Auvelity for depression and Alzheimer's agitation, Sunosi for excessive daytime sleepiness associated with sleep apnea and narcolepsy, and Symbravo for migraine.

Regulators approved Symbravo early last year, and they gave the nod to Auvelity in the Alzheimer's indication a couple of months ago. So these represent two new growth drivers for the company.

Today's Change

(

-1.68

%) $

-4.19

Current Price

$

245.57

Meanwhile, the earlier approvals have helped the company generate double-digit revenue gains. In the recent quarter, Auvelity's sales advanced 59% to $153 million, while Sunosi sales climbed 34% to $33 million. Symbravo, as a newer product, doesn't have comparative year-earlier sales, but it generated more than $4 million in revenue, and prescription trends are strong.

I also like the fact that Axsome has a full late-stage pipeline, with five phase 3 programs underway -- and the company recently applied for regulatory review of AXS-12 for narcolepsy. All of this should fuel growth down the road.

The case for Revolution Revolution is earlier-stage than Axsome since the company doesn't yet have commercialized products. But Revolution has candidates in registrational trials -- those that support regulatory review -- for the treatment of pancreatic cancer and non-small cell lung cancer. So the company is approaching the finish line, which means revenue may not be too far off.

Importantly, Revolution's technology could be game-changing, and recent results in a phase 3 trial were very strong. Revolution's tri-complex inhibitor platform has turned formerly "undruggable" targets into "druggable" ones. This platform is able to act on RAS proteins, turning off signaling that promotes the growth of cancer cells.

Today's Change

(

-0.36

%) $

-0.69

Current Price

$

189.77

The company's lead candidate, daraxonrasib, delivered record survival benefit in a phase 3 trial in pancreatic cancer, with median overall survival of 13.2 months versus 6.7 months for patients on the standard treatment of chemotherapy.

Though Revolution isn't generating product revenue now, if its technique and candidates continue along the current path, the company could be a major oncology winner over time.

Axsome and Revolution stock prices each climbed in the first half of the year, and over the long term, I would expect them to gain further. Today, though, I don't think investors have to rush to get in on Revolution. The stock has advanced significantly, in the triple digits, in a period of just a few months -- and stocks generally don't advance in a straight line upward forever. So I expect that there will be opportunities to buy Revolution on the dip.

As for Axsome, the company's growth is likely to happen sooner, considering it already has products on the market, and they are generating double-digit revenue growth. I also like the fact that Axsome has two recent approvals, as they are likely to offer revenue a boost as the products' sales advance. On top of this, a potential approval of AXS-12 could offer yet another revenue driver in the not-too-distant future.

And though Axsome stock has gained this year, there is still room for the stock to run. All of this makes Axsome the better growth buy right now.

July 07, 2026 07:00 ET  | Source: Axsome Therapeutics, Inc.

The FOCUS-2 trial in children complements the recently announced FOCUS-3 trial in adolescents with ADHD

NEW YORK, July 07, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that the first patient has been dosed in the FOCUS-2 Phase 3 trial evaluating solriamfetol as a treatment for children with attention deficit hyperactivity disorder (ADHD).

FOCUS-2 (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol in children aged 6 to less than 12 years with ADHD. Approximately 468 patients will be randomized in a 1:1:1 ratio to receive one of two doses of solriamfetol or placebo for 6 weeks. The primary endpoint will be the change from baseline to week 6 in the ADHD Rating Scale (ADHD-RS-5) total score.

Previously, Axsome announced the initiation of the FOCUS-3 Phase 3 trial of solriamfetol in adolescents aged 12 to less than 18 years with ADHD.

About Attention Deficit Hyperactivity Disorder (ADHD)

Attention deficit hyperactivity disorder (ADHD) is a chronic neurobiological and developmental disorder characterized by a persistent pattern of inattention, hyperactivity, or impulsivity, that interferes with functioning or development.1 Impairments in cognition are apparent in attention, planning and problem solving, working memory, and behavioral inhibition.2,3 An estimated 15.5 million adults and 7 million children in the U.S. are affected by ADHD,4,5 with approximately two-thirds or more of children with ADHD continuing to experience symptoms into adulthood.6 The total annual societal excess cost associated with adult ADHD in the U.S. has been estimated at over $120 billion.7

About Solriamfetol

Solriamfetol is a dopamine and norepinephrine reuptake inhibitor (DNRI), TAAR1 agonist, and 5-HT1A agonist being developed for the treatment of attention deficit hyperactivity disorder (ADHD), major depressive disorder (MDD) with excessive daytime sleepiness (EDS), binge eating disorder (BED), and excessive sleepiness associated with shift work disorder (SWD).

About Axsome Therapeutics

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.

Forward Looking Statements

Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company’s ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

Investors:
Ashley Dong
Senior Director, Investor Relations
(929) 687-1614
[email protected]

Media:
Darren Opland
Senior Director, Corporate Communications
(929) 837-1065
[email protected]

References:

American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, 5 ed., Arlington, VA: American Psychiatric Publishing, 2013.Brown TE. ADD/ADHD and Impaired Executive Function in Clinical Practice. Curr Psychiatry Rep. 2008 Oct;10(5):407-11.Nestler E., Hyman S., and Malenka R. Molecular Neuropharmacology: A Foundation for Clinical Neuroscience, Second Edition, 2nd ed., New York: McGraw-Hill Professional, 2008.Facts About ADHD in Adults. CDC. 2024.Data and Statistics on ADHD. CDC. 2024.Sibley MH et al. Variable Patterns of Remission From ADHD in the Multimodal Treatment Study of ADHD. Am J Psychiatry. 2022 Feb;179(2):142-151.Schein J et al. Economic burden of attention-deficit/hyperactivity disorder among adults in the United States: a societal perspective. J Manag Care Spec Pharm. 2022 Feb;28(2):168-179.

In this week’s edition of InnovationRx, we look at Axsome’s growing pipeline, HistoSonics innovative cancer treatment, state litigation over Medicaid work requirements, and more. To get it in your inbox, subscribe here.

Axsome's Herriot Tabuteau

Jamel Toppin for Forbes

Last October, when Forbes profiled Axsome Therapeutics founder and CEO Herriot Tabuteau, the company had three drugs on the market, five in the pipeline and a market cap of $6.1 billion. Since then, the stock has doubled, giving it a market cap of $12.6 billion—and Tabuteau a net worth of $2.2 billion. That performance is far ahead of shares of Alphabet (up 45% in the same time period), Eli Lilly (up 57%) or Nvidia (just 7%), to name just a few fast-growing giants.

Behind the rise: The New York-based company got approval for its drug Auvelity to treat the agitation that often accompanies Alzheimer’s disease. “We literally just launched it a couple of weeks ago. The reception has been tremendous,” Tabuteau, 57, tells Forbes.

When Tabuteau, who was born in Haiti and educated at Yale School of Medicine, started the drug development company in 2012, he decided to do things differently. He focused on drugs for brain disorders, which are notoriously difficult to develop and whose efficacy can be hard to prove. He also shunned venture capital, instead self-funding with help from family and friends. When Axsome went public in 2015, Wall Street was skeptical and the company’s stock puttered along under $10 for years.

But as we detailed last year, its prospects skyrocketed with its first big drug, Auvelity. When the treatment for major depressive disorder gained FDA approval in August 2022, the company’s shares popped 65% in a week, valuing the company at $3 billion.

Getting approval for the drug in Alzheimer’s agitation may be an even bigger deal. More than 7 million people in the U.S. have Alzheimer’s and Axsome figures that up to 76% of them experience agitation. Yet until now the only way to treat their symptoms has been with anti-psychotics, which have serious risks, including death. Scrutiny of antipsychotics’ usage has been increasing. A report from the Health and Human Services Office of the Inspector General in March found “alarming instances of inappropriate uses of antipsychotic drugs,” in a comprehensive review of 40 nursing home inspections, and noted that such inappropriate use has been a “longstanding concern for Congress and others.” Tabuteau points to the FDA’s unusual announcement heralding approval of the drug as the first non-antipsychotic for the indication as a sign of the new drug’s importance for public health.

Now Tabuteau (who Forbes recently named to its Immigrant 250 list) forecasts that the entire Auvelity franchise could reach $8 billion in peak sales, up from an earlier estimate of $6 billion, and he’s cranked up the company’s sales force to sell it. Potentially, Auvelity could be expanded to treat agitation in other forms of dementia, such as Lewy body dementia or vascular dementia, as well.

Axsome’s revenue reached $709 million for the latest 12 months (through the first quarter), up 64% from the same period the previous year. William Blair analyst Myles Minter now projects sales of $975 million for 2026 and $1.7 billion for 2027. In a recent research note, he wrote that not only were sales of the company’s drug for daytime sleepiness growing, but it also had “multiple shots on goal from additional pipeline assets,” including those for treatment of cataplexy (the sudden loss of muscle control) associated with narcolepsy and for fibromyglia.

“With the current pipeline, we are in position to file at least one new [drug application] every year, starting this year through 2030,” Tabuteau says. The company submitted an application for its narcolepsy medication earlier this year.

Tabuteau’s previous experience in finance–including stints at Goldman Sachs, Bank of America Securities and hedge fund Healthco/S.A.C. Capital, as well as managing his own funds–has paid off for Axsome. In late-2021, it bought the daytime sleepiness drug Sunosi for $53 million (plus single-digit royalties), then recouped its money when Tabuteau sold the European, Middle Eastern and North African rights.

That finance experience could pay off going forward as well. Since November, Axsome has acquired two additional therapeutic candidates: one to treat epilepsy, the other for schizophrenia and Tourette syndrome. It snagged the epilepsy drug by purchasing a small biotech that had originally licensed the therapy from AstraZeneca for just $300,000 upfront with potential milestone payments reaching $83 million, plus royalties. It acquired the schizophrenia and Tourette’s drug from Takeda for an undisclosed sum.

“It was not something that Takeda was looking to out-license, but based on our research we thought it was interesting so we did approach them and start a conversation,” Tabuteau says. He now figures that drug will be ready for phase 3 trials in patients with schizophrenia by the end of the year.

“Overall, if you look at our pipeline, it has the potential to generate peak sales of $20 billion-plus,” Tabuteau says. “There’s a lot more growth to be had, and we are very well positioned to deliver on that growth.”

This Startup Wants To Replace Cancer Surgery With UltrasoundCEO Mike Blue

HistoSonics

More than 500,000 cancer surgeries are performed every year in the United States. While these surgeries can often be successful, particularly when the cancer is caught early, they have high rates of complications, including infection, bleeding and chronic pain.

Mike Blue, CEO of HistoSonics, wants to change that. His company has developed a noninvasive technology system, called Edison, which utilizes histotripsy—sound waves that destroy tumors from the inside—to treat cancer and other conditions. The technique has fewer side effects than surgery: Just 6.8% of patients with liver cancer treated with Edison suffered complications, versus as high as 27% for conventional liver surgeries.

A team of researchers spun the Plymouth, Minn.-based company out of the University of Michigan in 2010 with an exclusive license to use its histotripsy technology. Edison received FDA clearance for use in patients with liver tumors in 2023. The company has sold more than 200 of its systems, which cost around $1.5 million, to hospitals such as the Cleveland Clinic and Cedars-Sinai.

It now hopes to use the Edison technology more broadly. It recently submitted an FDA application to use Edison against kidney tumors and it is testing the technology against pancreatic and prostate cancers. “We have the ability to deliver this beam therapy literally anywhere in the body,” he says. The company’s research teams are working on neurological diseases and women’s health issues, and they recently treated the first patients for benign prostatic hyperplasia, a non-cancerous enlargement of the prostate.

Last week, HistoSonics raised new financing from investors that include Yosemite, the venture firm founded by Reed Jobs. (Read our profile of Jobs here.) The amount of the investment was undisclosed, but it valued the company at $3.75 billion. The valuation is up 67% since last August, when a consortium of investors that included Jeff Bezos acquired a majority stake in the company at a valuation of $2.25 billion.

States Sue Over Medicaid Work RulesTwenty-five states and the District of Columbia sued the federal government on Monday over work requirements for Medicaid enrollees enacted as part of President Trump’s One Big, Beautiful Bill. These are expected to cost millions of low-income people their health insurance coverage when they go into effect on January 1st.

The new work rules require most Medicaid recipients between ages 19 and 64 to prove they work, attend school or volunteer at least 80 hours a month in order to keep their coverage. There are certain carveouts from the rules, including one for those considered “medically frail.” At issue in the lawsuit is who qualifies under that exemption. The new rule implicitly links the definition of “medical frailty” to the ability to work, which means someone who wants to claim the exemption needs to prove their health makes that impossible.

“People with disabilities, patients in the middle of cancer treatment, or those struggling with another serious or complex health condition, shouldn’t be at risk of losing the care that helps maintain their health,” according to the lawsuit filed in federal district court for Massachusetts.

The states suing include Massachusetts, California, New Jersey, Arizona, Maine, New Mexico and North Carolina.

What We’re ReadingStat investigates the ERs that can turn patients away–and are reaping millions.

The Justice Department spent years investigating Abbott’s baby formula facility and produced a pile of evidence for charges. Then it dropped the case.

A Congressional panel questioned Bristol Myers Squibb and Pfizer over their use of clinical trial sites in China.

The NIH is racing to spend its budget on grants before the end of the fiscal year–but will still hand out thousands fewer than it did before the second Trump Administration.

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June 15, 2026 07:00 ET  | Source: Axsome Therapeutics, Inc.

NEW YORK, June 15, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced presentations of new data on AXS-12 and solriamfetol at SLEEP 2026, the 40th annual meeting of the Associated Professional Sleep Societies (APSS), being held June 14-17, 2026, in Baltimore, Maryland.

Details of the presentations are as follows:

Title: Cognitive and Functional Outcomes from the Phase 3 Open-Label Extension and Randomized-Withdrawal ENCORE Trial of AXS-12 in Narcolepsy with Cataplexy
Presentation Date and Time: Monday, June 15, 10:00 - 11:45 a.m. ET
Lead Author: Bruce Corser MD, FAASM, Medical Director of Intrepid Research, Cincinnati, OH
Poster Presentation Session: P-16
Poster Number: 375 Title: Solriamfetol for Excessive Daytime Sleepiness in Narcolepsy and OSA: Post-hoc Multi-dimensional Composite Endpoint Analysis of Phase 3 Trials
Presentation Date and Time: Monday, June 15, 10:00 - 11:45 a.m. ET
Lead Author: Ellen Wertmer, FNP-BC, DBSM, FAASM, Founder of Restorative Sleep Medicine, Charlottesville, VA
Poster Presentation Session: P-16
Poster Number: 386 Title: Symptom Burden and Quality of Life in Patients with Narcolepsy Who Experience Residual Cataplexy: Subgroup Analysis from the CRESCENDO Survey
Presentation Date and Time: Tuesday, June 16, 10:00 - 11:45 a.m. ET
Lead Author: Michael Thorpy, MD, Director of the Sleep-Wake Disorders Center at the Montefiore Medical Center and Professor of Neurology at Albert Einstein College of Medicine, New York, NY
Poster Presentation Session: P-34
Poster Number: 316 About Axsome Therapeutics

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.

Forward Looking Statements

Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company’s ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

Investors:
Ashley Dong
Senior Director, Investor Relations
(929) 687-1614
[email protected]

Media:
Darren Opland
Senior Director, Corporate Communications
(929) 837-1065
[email protected]

Axsome Therapeutics, Inc. is rated Hold, as revenue growth and pipeline promise are offset by sequential declines and ongoing losses. AXSM's Q1 revenues grew 57% year-on-year to $191m, but both Auvelity and Sunosi saw sequential sales declines. Management's peak revenue targets—over $18bn across the portfolio—appear highly ambitious given current product performance and competitive dynamics.

Axsome Therapeutics, Inc. (AXSM) Q1 2026 Earnings Call Transcript

Smaller biotech stocks often fly under the radar. Many of them aren't consistently profitable, but some can deliver outsize growth for investors.

Axsome Therapeutics (AXSM +1.24%) is a mid-cap with only three approved therapies, while small-cap stock NovoCure (NVCR +0.45%) has approvals in four indications for its Tumor Treating Fields, and small-cap MBX Biosciences (MBX 5.97%) has several late-stage therapies in its pipeline. I like their potential and believe the markets haven't fully digested recent positive news for the trio.

Here's why I think each of these stocks could soar in 2026.

Image source: Getty Images.

Auvelity is bankrolling Axsome's pipeline progress Axsome just got great news that should help its bottom line. On May 1, the U.S. Food and Drug Administration (FDA) approved Axsome's drug Auvelity for a second major indication: Treating agitation associated with Alzheimer's disease. While Auvelity is already used for major depressive disorder (MDD), this new approval targets a condition with very few effective treatments. With a commercial launch set for June, the company is pivoting from a research-and-development-heavy biotech to a multi-product commercial powerhouse.

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Much of the Alzheimer's hype focuses on plaque-clearing drugs such as Leqembi. Axsome is tackling the behavioral side of the disease, which is often the primary reason patients are moved into long-term care facilities. This represents a massive, underserved market.

Auvelity was already seeing strong sales growth before the FDA's most recent decision. In 2025, Axsome reported full-year sales of $507.1 million for the drug, up 74%. The company's total revenue was $638.5 million, up 66%. It had an earnings per share (EPS) loss of $3.68, compared to an EPS loss of $5.69 in 2024.

The company's other products also saw double-digit growth. Sunosi, used to treat excessive daytime sleepiness, generated $124.8 million in revenue, up 32%, and migraine therapy Symbravo generated $6.6 million in its first year of sales.

NovoCure has a unique therapy NovoCure uses a proprietary technology called Tumor Treating Fields (TTFs) -- basically, electric fields that disrupt cancer cell division. In February, the FDA approved one of its TTFs, Optune Pax, for the treatment of advanced pancreatic cancer. The therapy provides a non-invasive option alongside chemotherapy. More than 52,000 people will die from pancreatic cancer in 2026, a disease that accounts for 8% of all cancer deaths, according to the National Cancer Institute.

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The stock has been volatile due to mixed results in other trials (such as lung cancer), leading some investors to write off the stock. However, the rapid certification of more than 800 healthcare providers immediately following this approval suggests that the clinical demand is far higher than the current market cap reflects.

The company reported that first-quarter revenue climbed 12% year over year to $174 million. This was mainly due to increased sales of Optune Gio, approved as monotherapy for brain metastasis and as combination therapy for glioblastoma, the most common malignant primary brain tumor. It was expected to affect nearly 14,000 people in the U.S. in 2025.

It is important to note that it will be a while before the company is profitable, as it is spending heavily on clinical trials and other R&D. It had a quarterly net loss of $71.1 million with an EPS loss of $0.62, compared to a loss of $34.3 million and an EPS loss of $0.31 in the same period a year ago.

MBX Biosciences is squeezing its way into the weight-loss sector For those looking at the next generation of the obesity and endocrine market, MBX is a quiet contender. The clinical-stage biotech focuses on protein endocrine pipeline (PEP) candidates designed to last longer and work better than current peptide drugs.

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Analysts are closely watching for a fourth-quarter readout of MBX's monthly GLP/GIP obesity candidate, MBX 4291. While Eli Lilly and Novo Nordisk dominate the weekly injection market, MBX aims for a once-a-month dosing schedule.

As a more recent entrant to the public markets, it hasn't enjoyed the same meme-stock status as other weight-loss names. However, its de-risked programs in rare endocrine diseases provide a valuation floor, while its obesity trials offer the high-upside moonshot potential.

MBX's pipeline also includes MBX 1416 (Phase 2 for post-bariatric hypoglycemia) and two preclinical obesity therapies.

The company doesn't have any product revenue, but it does have $459.1 million in cash. MBX said that that's enough to fund its operations into 2029.

This could be a breakthrough year for all three Small biotech stocks offer high rewards alongside a healthy dose of risk. Ultimately, 2026 is shaping up to be a year of validation for these diverse therapeutic approaches. Between Axsome's pivot toward behavioral neurology, NovoCure's unique electrical disruption of cancer cells, and MBX's pursuit of monthly dosing for metabolic health, the trio represents a high-upside cross-section of modern biotechnology.

As these companies continue to reach clinical readouts and commercial launch dates, the disparity between their current valuations and their market potential offers a compelling window for growth-oriented investors to capitalize on breakthroughs that are just beginning to reach the patients who need them most.

May 07, 2026 07:00 ET  | Source: Axsome Therapeutics, Inc.

NEW YORK, May 07, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced its support for Mental Health Month alongside the broader mental health advocacy community. In recognition of this year’s More Good Days Together theme, Axsome is sharing resources to support individuals affected by mental health conditions, their families, and the communities around them.

“At Mental Health America, we are proud to have established Mental Health Month in 1949, with the goal of educating the public about mental illness, mental health, and recovery,” said Pierluigi Mancini, PhD, interim president and CEO of Mental Health America (MHA). “Our 2026 campaign, More Good Days, Together, provides tools and resources that meet people where they are, support them as whole people, and acknowledge that 'good' is defined by their unique experience and goals. The path may look different for everyone, but we all deserve more good days, together."

Mental health conditions are highly prevalent in the U.S., with nearly 1 in 4 adults living with a mental illness.1 Major depressive disorder (MDD), one of the most common mental health conditions, is a leading cause of disability worldwide and impacts over 21 million adults in the U.S. alone.1-3 Nearly 90% of people living with depression report difficulty with work, home, or social activities due to their symptoms, underscoring the impact depression can have on day-to-day life.4

Axsome’s mission is to develop and deliver transformative medicines to improve the brain health of millions of individuals affected by central nervous system conditions, including those living with difficult-to-treat mental illness. To help raise awareness and promote action during Mental Health Month, Axsome is highlighting non-profit organizations and resources that provide education, tools, and community support for individuals and families affected by mental health conditions, including:

2026 Mental Health Month Action Guide (https://mhanational.org/2026-mental-health-month-action-guide/) MHA’s work is driven by its commitment to promote mental health as a critical part of overall wellness, including prevention services for all; early identification and intervention for those at risk; and integrated care, services, and support for those who need them, with recovery as the goal. Its 2026 Mental Health Month Action Guide provides access to online activities, articles, printable tools, and practical resourcesAnxiety and Depression Association of America (ADAA)’s “Find Your Therapist” platform (https://findyourtherapist.adaa.org/) helps connect people with licensed mental health professionals who specialize in treating anxiety, depression, OCD, PTSD, and other related disorders. This aligns with ADAA’s 2026 annual conference theme around “Innovations in Technology Driving Clinical Care and Research in Mood and Anxiety Disorders,” and the organizations commitment to improving live through collaboration, research, education, and innovation.   The National Alliance on Mental Illness (NAMI) New York Chapter (https://naminycmetro.org/), guided by lived experience and evidence-based practices, helps families and individuals affected by mental illness build better lives through education, support, and advocacy. Later this month NAMI-NYC is hosting its annual Mental Health Street Fest, which is the nation’s largest mental health event, being held since 2007: https://www.namiwalks.org/nyc.
If you or someone you know is in crisis, the 988 Suicide & Crisis Lifeline (https://988lifeline.org/) is a free confidential support service available 24 hours a day, 7 days a week across the United States. When people call, text, or chat 988, they will be connected to trained counselors that are part of the existing Lifeline network. These trained counselors will listen, understand how their problems are affecting them, provide support, and connect them to resources if necessary.

About Axsome Therapeutics

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.

Forward Looking Statements

Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company’s ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

Investors:
Ashley Dong
Senior Director, Investor Relations
(929) 687-1614
[email protected]

Media:
Darren Opland
Senior Director, Corporate Communications
(929) 837-1065
[email protected]

References:

Substance Abuse and Mental Health Services Administration. Key Substance Use and Mental Health Indicators in the United States: Results from the 2023 National Survey on Drug Use and Health. July 2024. https://www.samhsa.gov/data/report/2023-nsduh-annual-national-reportWorld Health Organization. Depression and Other Common Mental Disorders: Global Health Estimates. 2017.https://www.who.int/publications/i/item/depression-global-health-estimatesNational Institute of Mental Health. Major Depression. Accessed February 2026. https://www.nimh.nih.gov/health/statistics/major-depressionBrody DJ, Hughes JP. Depression prevalence in adolescents and adults: United States, August 2021–August 2023. 2025 Apr; (527)1–11. DOI: https://dx.doi.org/10.15620/cdc/174579.

Axsome Therapeutics, Inc. (AXSM) Presents at Bank of America Global Healthcare Conference 2026 Transcript

May 26, 2026 07:00 ET  | Source: Axsome Therapeutics, Inc.

NEW YORK, May 26, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced presentations of new AUVELITY® data in major depressive disorder at the American Society of Clinical Psychopharmacology (ASCP) 2026 Annual Meeting being held from May 26-29 in Miami, FL.

Details of the presentations are as follows:

Title: Effects of Dextromethorphan-Bupropion (45 mg/105 mg) in Participants with Major Depressive Disorder and Anxious Distress
Presentation Date and Time: Wednesday, May 27, 11:45 a.m. - 1:30 p.m. ET
Lead Author: Jeffrey R. Strawn, MD, Professor of Psychiatry and Behavioral Neuroscience, University of Cincinnati, OH
Poster Number: W42 Title: Anxiolytic Effects of Dextromethorphan-Bupropion (45 mg/105 mg): Post Hoc Analyses Across Trials in Major Depressive Disorder
Presentation Date and Time: Wednesday, May 27, 11:45 a.m. - 1:30 p.m. ET
Lead Author: Jeffrey R. Strawn, MD, Professor of Psychiatry and Behavioral Neuroscience, University of Cincinnati, OH
Poster Number: W50 Title: Real-World Clinical Outcomes of Patients Switching to Treatment with Dextromethorphan-Bupropion (45 mg/105 mg) 
Presentation Date and Time: Thursday, May 28, 11:45 a.m. - 1:15 p.m. ET
Lead Author: Joel L. Young, MD, Medical Director of the Rochester Center for Behavioral Medicine, NY
Poster Number: T34 Title: Effects of Solriamfetol on Neuropsychological Outcomes in Patients with Obstructive Sleep Apnea in the Real-World SURWEY Study 
Presentation Date and Time: Thursday, May 28, 11:30 a.m. - 1:15 p.m. ET
Lead Author: Yaroslav Winter, MD, Mainz Comprehensive Epilepsy and Sleep Medicine Center, Department of Neurology, Johannes Gutenberg-University, Mainz, Germany
Poster Number: T29 About Axsome Therapeutics

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.

Forward-Looking Statements

Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company’s ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

Investors:
Ashley Dong
Senior Director, Investor Relations
(929) 687-1614
[email protected]

Media:
Darren Opland
Senior Director, Corporate Communications
(929) 837-1065
[email protected]

June 01, 2026 07:00 ET  | Source: Axsome Therapeutics, Inc.

NEW YORK, June 01, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today highlighted its commitment to the migraine community by supporting educational initiatives during Migraine and Headache Awareness Month this June.

“People living with migraine and headache disorders deserve to be seen, believed, and supported with information and care that reflect the seriousness of these diseases,” said Julienne Verdi, Executive Director of The Headache Alliance and the Alliance for Headache Disorders Advocacy. “Awareness campaigns like Headache in the City help the public better understand the real impact of headache disease and why early diagnosis, treatment, and connection to care matter. The Headache Alliance is proud to lead educational and awareness efforts that reduce stigma, connect people with trusted resources, and help more people understand that better days are possible with the right care.”

Migraine is a debilitating condition characterized by recurrent attacks of pulsating, often severe and disabling head pain, accompanied by nausea, sensitivity to light, and/or sensitivity to sound.1 Migraine affects approximately 40 million people in the U.S. and is the second leading cause of disability worldwide.2,3

To help raise awareness for the impact that migraine has on millions of Americans that live in major cities, Axsome is supporting the first annual Headache in the City educational campaign from the Headache Alliance on June 15 in New York City. Additionally, on June 4, Axsome’s New York City headquarters, One World Trade Center, will be lit in purple, the color for migraine awareness, through the building’s Spireworks program, to help promote awareness efforts.

Axsome is also sharing the following resources from some of the leading migraine advocacy organizations:

American Migraine Foundation Find a Doctor (https://americanmigrainefoundation.org/find-a-doctor/) is a resource to help patients find medical professionals experienced in migraine and headache care.Association of Migraine Disorders Migraine Explainer Videos (https://www.migrainedisorders.org/education/patient-resources/videos/) are educational videos that describe different types of migraines, symptoms, treatments, and pathophysiology.CHAMP Financial Assistance Guides (https://headachemigraine.org/migraine-financial-assistance-guides/) outline financial assistance programs operated by pharmaceutical companies and device manufacturers to help patients cover the cost of accessing treatment.National Headache Foundation podcast (https://headaches.org/category/podcast/head-wise/) features informative discussions with headache experts on the latest treatment, research, lifestyle recommendations, and personal stories about living with migraine disease and headache disorders. About Axsome Therapeutics

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.

Forward Looking Statements

Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company’s ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

Investors:
Ashley Dong
Senior Director, Investor Relations
(929) 687-1614
[email protected]

Media:
Darren Opland
Senior Director, Corporate Communications
(929) 837-1065
[email protected]

References:

Headache Classification Committee of the International Headache Society (IHS) Cephalalgia (2018)American Migraine Foundation (2023), https://americanmigrainefoundation.org/, accessed May 2, 2025.Steiner TJ, Stovner LJ, Jensen R, Uluduz D, Katsarava Z. Migraine remains second among the world's causes of disability, and first among young women: findings from GBD2019. J Headache Pain. 2020 Dec 2;21(1):137.

It has been about a month since the last earnings report for Axsome Therapeutics (AXSM - Free Report) . Shares have lost about 0.4% in that time frame, underperforming the S&P 500.

But investors have to be wondering, will the recent negative trend continue leading up to its next earnings release, or is Axsome due for a breakout? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important catalysts.

Axsome Q1 Loss Widens, Revenues Rise on Higher Auvelity SalesAxsome incurred a loss of $1.26 per share in the first quarter of 2026, wider than the Zacks Consensus Estimate of a loss of 85 cents. The company had reported a loss of $1.22 per share in the year-ago quarter.

Axsome’s total revenues surged 57.4% year over year to $191.2 million in the first quarter, beating the Zacks Consensus Estimate of $189 million. The year-over-year increase in revenues was primarily driven by strong sales of Auvelity as well as other marketed drugs.

Quarter in DetailTotal revenues in the first quarter consisted of product revenues from Auvelity, Sunosi, and the newest drug, Symbravo, as well as royalty and milestone revenues.

Net product revenues were $189.4 million in the quarter, reflecting an increase of 57.4% year over year. Royalty and milestone revenues totaled $1.8 million in the quarter, reflecting royalties on Sunosi’s sales in out-licensed territories.

Auvelity recorded sales of $153.2 million, up 59% from the year-ago quarter’s level. Sales of the drug beat the Zacks Consensus Estimate of $144 million.

Per Axsome, around 223,000 prescriptions were recorded for Auvelity in the first quarter, reflecting a year-over-year increase of 35%.

Sunosi’s net product sales were $33.9 million in the quarter, up 34% from the year-ago quarter’s level. Total prescriptions for Sunosi in the United States grew 16% year over year to 54,000.

Axsome’s newest drug, Symbravo, was launched in June 2025 in the United States. Sales of the drug came in at $4.1 million in the first quarter and were flat sequentially. Symbravo’s sales missed the Zacks Consensus Estimate of $6.7 million.

Total prescriptions for Symbravo grew 36% sequentially to 17,000 in the first quarter of 2026.

Research and development expenses (including stock-based compensation) were $52.7 million, up 17.6% from the year-ago quarter’s level, due to a one-time acquisition-related expense.

Selling, general and administrative expenses (including stock-based compensation) totaled $185 million, up 53.1% year over year. The increase was due to higher commercial activities for Auvelity and Symbravo, and also the ongoing pre-launch activities for Auvelity for the Alzheimer’s disease agitation indication.

As of March 31, 2026, Axsome had cash and cash equivalents worth $305.1 million compared with $322.9 million as of Dec. 31, 2025.

How Have Estimates Been Moving Since Then?In the past month, investors have witnessed a downward trend in estimates revision.

The consensus estimate has shifted -69.78% due to these changes.

VGM ScoresAt this time, Axsome has a great Growth Score of A, though it is lagging a lot on the Momentum Score front with an F. Charting a somewhat similar path, the stock was allocated a grade of D on the value side, putting it in the bottom 40% for value investors.

Overall, the stock has an aggregate VGM Score of C. If you aren't focused on one strategy, this score is the one you should be interested in.

OutlookEstimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. Interestingly, Axsome has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months.

Axsome Therapeutics, Inc. (AXSM) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript