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Axsome Therapeutics, Inc. (AXSM) Presents at Wells Fargo 21st Annual Healthcare Conference Transcript

 | Source: Axsome Therapeutics, Inc.

NEW YORK, Sept. 02, 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 it will participate in the following upcoming investor conferences in September:

Wells Fargo 21st Annual Healthcare Conference
Fireside Chat: Wednesday, September 9, 2026, at 3:45 p.m. ET in Boston, MA 2026 Cantor Global Healthcare Conference
Fireside Chat: Thursday, September 10, 2026, at 2:45 p.m. ET in New York, NY Morgan Stanley 24th Annual Global Healthcare Conference
Fireside Chat: Monday, September 14, 2026, at 1:50 p.m. ET in New York, NY Baird 2026 Global Healthcare Conference
Fireside Chat: Tuesday, September 15, 2026, at 2:35 p.m. ET in New York, NY H.C. Wainwright 28th Annual Global Investment Conference
Presentation: Wednesday, September 16, 2026, at 10:00 a.m. ET in New York, NY Deutsche Bank 2026 Healthcare Summit
Investor Meetings: Thursday, September 17, 2026, in New York, NY Live webcasts of the Wells Fargo, Cantor, H.C. Wainwright, and Morgan Stanley sessions can be accessed on the “Webcasts & Presentations” page of the “Investors” section of the Company’s website at axsome.com. Replays of the webcasts will be available for approximately 30 days following each event.

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]

 | Source: Axsome Therapeutics, Inc.

NEW YORK, Aug. 31, 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 SUMMIT Phase 3 trial of AXS-05 for smoking cessation.

SUMMIT (Studying NMDA and Sigma-1 in Smoking Cessation Treatment) is a Phase 3 randomized, double-blind, active- and placebo-controlled, multicenter trial to assess the efficacy and safety of AXS-05 as a smoking cessation treatment in adults. Active smokers will be randomized in a 1:1:1 ratio to receive AXS-05, bupropion, or placebo for approximately 12 weeks. The primary endpoint will be smoking abstinence at the end of the 12-week treatment period.    

About Smoking Cessation

Approximately 34 million adults in the U.S. smoke cigarettes and more than half of those live with a smoking-related disease.1 Smoking is the single largest cause of preventable disease in the U.S., accounting for 1 in 5 deaths.2 The overall cost of smoking exceeds $300 billion annually in the U.S. making it a significant health-economic need.1 Nearly 70% of adult smokers say they want to quit but only 3-5% who attempt to quit without assistance are successful for 6-12 months.1,3

About AXS-05

AXS-05 (dextromethorphan-bupropion) is a novel, oral, investigational N-methyl-D-aspartate (NMDA) receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor under development for smoking cessation. AXS-05 is covered by a robust patent estate extending out to at least 2043. AXS-05 (AUVELITY®) is approved in the U.S. for the treatment of major depressive disorder in adults and agitation associated with dementia due to Alzheimer’s disease. AXS-05 is not approved by the FDA as a smoking cessation treatment.

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, and multiple late-stage development programs 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:

U.S. Department of Health and Human Services. (2020). Smoking Cessation: A Report of the Surgeon General.U.S. Centers for Disease Control and Prevention. (2020). Tobacco-Related MortalityHughes, J.R. et al. Shape of the relapse curve and long-term abstinence among untreated smokers. Addiction. 2003. (99):29-38.

Axsome Therapeutics (AXSM -0.13%), a biotech company, has performed fairly well this year. The company's shares are up 16% versus the S&P 500's 11%. Could the stock rise even higher? Wall Street certainly thinks so. Axsome Therapeutics' average price target (according to Yahoo! Finance) of $285.42 implies about a 37% upside from its current level. Let's find out why Wall Street is bullish on the stock and whether it's time to buy it.

Image source: The Motley Fool.

Axsome Therapeutics' recent financial results Axsome Therapeutics has made significant clinical and regulatory progress over the past few years. The company earned approval for Auvelity as a treatment for depression, and more recently won a label expansion for the medicine in treating Alzheimer's disease (AD) agitation. Axsome Therapeutics' approved portfolio also includes Symbravo, a migraine therapy, and Sunosi, which treats daytime sleepiness due to narcolepsy. Axsome Therapeutics' sales are growing rapidly. In the second quarter, the company's revenue increased by 46% year over year to $218.4 million. Auvelity is the main growth driver.

It contributed $180.3 million in net product sales, up 51% compared to the year-ago period. The good news is that Auvelity's indication in AD agitation is still brand-new. The U.S. Food and Drug Administration granted it in April. So, as the medicine gains significant traction in this market, it will help boost its sales. And there is a large addressable opportunity here. AD agitation affects more than five million patients in the U.S., and treatment options are limited.

So, Auvelity could fill an unmet need. Eventually, it could also earn another label expansion in smoking cessation, since Axsome is gearing up to start a phase 2/3 study in that indication. Axsome Therapeutics' Sunosi could also receive label expansions. It is currently being investigated in phase 3 studies as a potential treatment for depression, ADHD, and binge eating disorder. If it can land these additional approvals, it would become more successful and help improve Axsome Therapeutics' financial results.

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Why the future looks bright Axsome Therapeutics' pipeline doesn't end with Auvelity and Sunosi. In fact, the company boasts a rich lineup of mid and late-stage candidates that could transform its approved portfolio over the next few years. Here are some of these products. One of them is AXS-12, an investigational medicine for cataplexy in narcolepsy. This candidate has already cleared phase 3 studies and is currently under review by U.S. regulators.

Axsome Therapeutics estimates peak sales for AXS-12 between $500 million and $1 billion in narcolepsy. Then there is AXS-14, an investigational therapy for fibromyalgia. It is currently undergoing late-stage studies, as is the biotech's AXS-20, which is being developed to treat schizophrenia. Between these and other products in development, Axsome Therapeutics estimates that it could generate peak sales above $16 billion.

The company won't get there in a year or two. But considering its current market cap of roughly $11 billion, Axsome Therapeutics may be an attractive stock to buy even if it can land $16 billion in annual revenue by 2040. Here is why. Assuming a price-to-sales ratio of 3 by 2040 -- which is a reasonable assumption in the biotech industry -- if Axsome Therapeutics generates $16 billion in revenue by then, the company's market cap will be $48 billion. From its current level of $11 billion, it would grow at a compound annual rate of 11.1% over the next 14 years, which is a pretty strong return.

Of course, there are risks. Axsome Therapeutics could fail to launch one or more of its current pipeline projects due to clinical or regulatory setbacks. It could also face stronger competition in markets where it currently performs well, such as depression treatments, where several pharmaceutical giants dominate. However, the $16 billion projection only takes into account the company's more advanced programs, not several earlier projects that may also contribute to the top-line down the road.

So, even with the risk of clinical setbacks, Axsome Therapeutics has a large enough pipeline to generate competitive returns over the long run. Wall Street is right to be bullish, and investors should seriously consider buying this healthcare stock.

Key Takeaways Axsome's Q2 revenues rose 46%, led by strong Auvelity sales and growth in other marketed drugs.AXSM's Auvelity Q2 sales jumped 51% to $180.3 million, with prescriptions rising 34% year over year.Sunosi sales increased 20%, while Symbravo prescriptions grew 30% sequentially despite lower sales in Q2. Axsome Therapeutics (AXSM - Free Report) incurred a loss of 99 cents per share in the second quarter of 2026, which was in line with the Zacks Consensus Estimate. The company had reported a loss of 97 cents per share in the year-ago quarter.

Axsome’s total revenues surged 46% year over year to $218.4 million in the second quarter. The increase in revenues was primarily driven by strong sales of lead drug Auvelity (AXS-05) as well as other marketed drugs. The top line, however, missed the Zacks Consensus Estimate of $225 million.

Auvelity is approved for the treatment of major depressive disorder (MDD). In April 2026, the FDA approved Auvelity for the treatment of agitation associated with dementia due to Alzheimer’s disease. The approval was based on data from phase III ADVANCE-1 and ACCORD-2 studies.

Year to date, shares of Axsome have rallied 21% compared with the industry’s increase of 6.1%.

Image Source: Zacks Investment Research

AXSM’s Q2 Earnings in DetailTotal revenues in the second quarter consisted of product revenues from Auvelity, Sunosi (solriamfetol) and Axsome’s newest drug, Symbravo (meloxicam and rizatriptan), as well as royalty and milestone revenues.

Net product revenues were $216.4 million in the quarter, reflecting an increase of 45.2% year over year. Royalty and milestone revenues totaled $2 million in the quarter, reflecting royalties on Sunosi’s sales in out-licensed territories.

Auvelity recorded sales of $180.3 million, up 51% from the year-ago quarter’s level. Sales of the drug beat the Zacks Consensus Estimate of $175 million.

Per Axsome, around 266,000 total prescriptions were recorded for Auvelity in the second quarter, reflecting a year-over-year increase of 34%.

Sunosi’s net product sales were $35.8 million in the quarter, up 20% from the year-ago quarter’s level. Total prescriptions for Sunosi in the United States grew 14% year over year to 61,000. Sunosi sales beat the Zacks Consensus Estimate of $33.4 million.

Axsome acquired U.S. rights to Sunosi from Jazz Pharmaceuticals (JAZZ - Free Report) in 2022.

Axsome out-licensed its ex-U.S. marketing rights of Sunosi to Pharmanovia in February 2023. JAZZ is entitled to receive a high single-digit royalty from AXSM on net sales of Sunosi in the United States.

Axsome’s newest drug, Symbravo, was launched in June 2025 in the United States. Sales of the drug came in at $2.3 million in the second quarter, down from $4.1 million recorded in the prior quarter. Symbravo’s sales missed the Zacks Consensus Estimate of $7.2 million. 

However, total prescriptions for Symbravo grew 30% sequentially to 23,500 in the second quarter of 2026.

Research and development expenses (including stock-based compensation) were $46.2 million, down 6.7% from the year-ago quarter’s level, primarily due to lower costs related to Auvelity and AXS-14.

Selling, general and administrative expenses (including stock-based compensation) totaled $208.1 million, up 59.7% year over year. The increase was due to higher commercial activities for Auvelity, including the ongoing pre-launch activities for the Alzheimer’s disease agitation indication and Symbravo.

As of June 30, 2026, Axsome had cash and cash equivalents worth $319.9 million compared with $305.1 million as of March 31, 2026. Management believes that its cash balance as of June-end is sufficient to fund future operations into cash flow positivity.

AXSM's Recent Pipeline UpdatesAxsome plans to initiate a pivotal phase II/III study of AXS-05 for treating smoking cessation later in the third quarter of 2026.

Other pipeline candidates include AXS-12, AXS-14 and AXS-17, which target multiple central nervous system indications.

In July 2026, the FDA accepted Axsome’s new drug application (NDA) seeking approval for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy. With the FDA accepting the NDA for review, a decision from the regulatory body is expected on May 1, 2027.

Axsome is evaluating the efficacy and safety of AXS-14 (esreboxetine) under the phase III FORWARD study for the management of fibromyalgia.

AXS-17 is another pipeline asset of Axsome, which is being developed for epilepsy. The phase II study-enabling activities for AXS-17 in epilepsy are underway. The company plans to develop AXS-20 for schizophrenia and Tourette syndrome, with phase III study-enabling activities in schizophrenia currently underway.

Axsome is advancing solriamfetol across multiple phase III studies for treating attention-deficit hyperactivity disorder (ADHD), MDD, binge eating disorder (BED) and shift work disorder (SWD).

The company recently dosed the first patient in the phase III FOCUS-2 study and the phase III FOCUS-3 study evaluating solriamfetol for the treatment of ADHD in children and in adolescents, respectively.

The phase III CLARITY study evaluating solriamfetol for the treatment of MDD patients with excessive daytime sleepiness symptoms began in February 2026.

Top-line data from the ENGAGE study evaluating solriamfetol for treating BED is expected in the fourth quarter of 2026. Top-line data from the SUSTAIN study evaluating solriamfetol for treating SWD in adults is expected in 2027.

AXSM's Zacks Rank & Stocks to ConsiderAxsome currently carries a Zacks Rank #4 (Sell).

Some better-ranked stocks in the biotech sector are Repligen (RGEN - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.62 during the same time. RGEN shares have declined 0.4% year to date.

Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.

Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $2.97 to $3.02, while estimates for 2027 have increased from $4.81 to $5.31 during the same time. LQDA shares have surged 163.9% year to date.

Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.

Axsome Therapeutics, Inc. (AXSM) Q2 2026 Earnings Call Transcript

Axsome Therapeutics (AXSM - Free Report) came out with a quarterly loss of $0.99 per share in line with the Zacks Consensus Estimate. This compares to a loss of $0.92 per share a year ago. These figures are adjusted for non-recurring items.

A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.85 per share when it actually produced a loss of $1.26, delivering a surprise of -48.24%.

Over the last four quarters, the company has not been able to surpass consensus EPS estimates.

Axsome, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $218.38 million for the quarter ended June 2026, missing the Zacks Consensus Estimate by 2.74%. This compares to year-ago revenues of $150.04 million. The company has topped consensus revenue estimates three times over the last four quarters.

The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.

Axsome shares have added about 16.5% since the beginning of the year versus the S&P 500's gain of 13.3%.

What's Next for Axsome?While Axsome has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?

There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.

Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.

Ahead of this earnings release, the estimate revisions trend for Axsome was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.

It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.53 on $265.7 million in revenues for the coming quarter and -$2.48 on $982.54 million in revenues for the current fiscal year.

Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the bottom 40% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.

Another stock from the same industry, Kamada (KMDA - Free Report) , has yet to report results for the quarter ended June 2026. The results are expected to be released on August 12.

This biopharmaceutical is expected to post quarterly earnings of $0.12 per share in its upcoming report, which represents a year-over-year change of -7.7%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.

Kamada's revenues are expected to be $51.62 million, up 15.4% from the year-ago quarter.

Posted by Defense World Staff on Aug 10th, 2026

Axsome Therapeutics, Inc. (NASDAQ:AXSM – Get Free Report) CEO Herriot Tabuteau sold 4,660 shares of the business’s stock in a transaction dated Thursday, August 6th. The shares were sold at an average price of $213.95, for a total value of $997,007.00. Following the completion of the transaction, the chief executive officer directly owned 7,229 shares in the company, valued at $1,546,644.55. This represents a 39.20% decrease in their ownership of the stock. The sale was disclosed in a document filed with the Securities & Exchange Commission, which can be accessed through this hyperlink.

Herriot Tabuteau also recently made the following trade(s):

On Wednesday, August 5th, Herriot Tabuteau sold 45,004 shares of Axsome Therapeutics stock. The stock was sold at an average price of $212.01, for a total value of $9,541,298.04. On Wednesday, July 1st, Herriot Tabuteau sold 49,666 shares of Axsome Therapeutics stock. The stock was sold at an average price of $240.25, for a total value of $11,932,256.50. On Tuesday, June 9th, Herriot Tabuteau sold 49,670 shares of Axsome Therapeutics stock. The shares were sold at an average price of $241.01, for a total value of $11,970,966.70. Axsome Therapeutics Price Performance Shares of AXSM opened at $212.74 on Monday. The firm has a market cap of $10.95 billion, a PE ratio of -57.03 and a beta of 0.65. Axsome Therapeutics, Inc. has a 52-week low of $102.67 and a 52-week high of $260.19. The business’s 50 day moving average price is $236.95 and its two-hundred day moving average price is $204.15. The company has a debt-to-equity ratio of 2.27, a quick ratio of 1.32 and a current ratio of 1.39.

Analyst Upgrades and Downgrades Several research analysts recently issued reports on AXSM shares. Cantor Fitzgerald reissued an “overweight” rating and set a $272.00 target price on shares of Axsome Therapeutics in a research note on Monday, May 4th. HC Wainwright reiterated a “buy” rating and set a $290.00 price objective on shares of Axsome Therapeutics in a report on Wednesday, July 15th. Deutsche Bank Aktiengesellschaft set a $280.00 price objective on shares of Axsome Therapeutics in a research report on Tuesday, May 5th. Piper Sandler restated an “overweight” rating and issued a $258.00 target price on shares of Axsome Therapeutics in a research note on Monday, May 4th. Finally, Weiss Ratings reaffirmed a “sell (d-)” rating on shares of Axsome Therapeutics in a research report on Friday, July 17th. Two analysts have rated the stock with a Strong Buy rating, eighteen have issued a Buy rating and two have assigned a Sell rating to the stock. Based on data from MarketBeat, the company presently has an average rating of “Moderate Buy” and an average target price of $265.55.

Read Our Latest Research Report on Axsome Therapeutics

Institutional Inflows and Outflows Several institutional investors have recently bought and sold shares of AXSM. Meeder Advisory Services Inc. bought a new position in shares of Axsome Therapeutics in the second quarter valued at $311,000. BlackRock Inc. acquired a new stake in shares of Axsome Therapeutics in the 2nd quarter worth about $759,695,000. Pallas Capital Advisors LLC acquired a new stake in shares of Axsome Therapeutics in the 2nd quarter worth about $9,916,000. Deutsche Bank AG bought a new position in Axsome Therapeutics in the 2nd quarter valued at about $21,164,000. Finally, Trust Co. of Vermont bought a new position in Axsome Therapeutics in the 2nd quarter valued at about $98,000. Institutional investors and hedge funds own 81.49% of the company’s stock.

Axsome Therapeutics Company Profile (Get Free Report)

Axsome Therapeutics, Inc is a clinical-stage biopharmaceutical company dedicated to developing novel therapies for central nervous system (CNS) disorders. The company focuses on small-molecule drugs designed to address unmet medical needs in areas such as depression, migraine, narcolepsy and fibromyalgia. Axsome employs a precision medicine approach, leveraging pharmacologic innovation to target underlying mechanisms of disease and improve patient outcomes.

Axsome’s pipeline includes several late-stage and approved product candidates.

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Posted by Defense World Staff on Aug 8th, 2026

Assenagon Asset Management S.A. lowered its holdings in Axsome Therapeutics, Inc. (NASDAQ:AXSM – Free Report) by 47.5% in the 2nd quarter, according to the company in its most recent 13F filing with the SEC. The institutional investor owned 454,682 shares of the company’s stock after selling 411,276 shares during the quarter. Assenagon Asset Management S.A. owned approximately 0.88% of Axsome Therapeutics worth $111,293,000 at the end of the most recent reporting period.

Other hedge funds have also recently modified their holdings of the company. GAMMA Investing LLC grew its stake in shares of Axsome Therapeutics by 14.9% in the 2nd quarter. GAMMA Investing LLC now owns 347 shares of the company’s stock valued at $85,000 after buying an additional 45 shares during the period. Birchview Capital LP boosted its holdings in Axsome Therapeutics by 1.0% during the 4th quarter. Birchview Capital LP now owns 6,061 shares of the company’s stock valued at $1,107,000 after acquiring an additional 61 shares during the period. PNC Financial Services Group Inc. grew its holdings in shares of Axsome Therapeutics by 3.5% in the fourth quarter. PNC Financial Services Group Inc. now owns 1,921 shares of the company’s stock valued at $351,000 after purchasing an additional 65 shares in the last quarter. Xponance LLC increased its position in shares of Axsome Therapeutics by 2.4% during the fourth quarter. Xponance LLC now owns 3,265 shares of the company’s stock worth $596,000 after acquiring an additional 76 shares during the period. Finally, Assetmark Inc. raised its position in Axsome Therapeutics by 7.2% in the 1st quarter. Assetmark Inc. now owns 1,182 shares of the company’s stock valued at $200,000 after purchasing an additional 79 shares in the last quarter. Hedge funds and other institutional investors own 81.49% of the company’s stock.

Insider Activity at Axsome Therapeutics In other news, Director Mark Coleman sold 6,000 shares of the business’s stock in a transaction on Monday, June 1st. The shares were sold at an average price of $230.30, for a total transaction of $1,381,800.00. Following the completion of the sale, the director directly owned 35,140 shares of the company’s stock, valued at $8,092,742. The trade was a 14.58% decrease in their position. The sale was disclosed in a filing with the Securities & Exchange Commission, which is available at this link. Also, Director Susan Mahony sold 300 shares of the business’s stock in a transaction dated Tuesday, June 9th. The stock was sold at an average price of $237.21, for a total value of $71,163.00. Following the sale, the director owned 1,129 shares of the company’s stock, valued at $267,810.09. The trade was a 20.99% decrease in their position. The SEC filing for this sale provides additional information. The sale was made to cover tax withholding obligations related to the vesting of equity awards. Insiders have sold 200,766 shares of company stock worth $46,685,646 in the last 90 days. Company insiders own 20.60% of the company’s stock.

Axsome Therapeutics Stock Performance Axsome Therapeutics stock opened at $212.74 on Friday. The stock has a fifty day moving average price of $236.95 and a 200 day moving average price of $203.96. The company has a current ratio of 1.39, a quick ratio of 1.32 and a debt-to-equity ratio of 2.27. Axsome Therapeutics, Inc. has a 52 week low of $102.67 and a 52 week high of $260.19. The firm has a market capitalization of $10.95 billion, a P/E ratio of -57.03 and a beta of 0.65.

Analyst Upgrades and Downgrades Several equities research analysts have recently issued reports on the stock. UBS Group lifted their price objective on shares of Axsome Therapeutics from $251.00 to $259.00 and gave the stock a “buy” rating in a research report on Friday, April 10th. HC Wainwright reissued a “buy” rating and set a $290.00 price objective on shares of Axsome Therapeutics in a research report on Wednesday, July 15th. Deutsche Bank Aktiengesellschaft set a $280.00 price target on Axsome Therapeutics in a research note on Tuesday, May 5th. Truist Financial raised Axsome Therapeutics to a “strong-buy” rating in a report on Monday, June 15th. Finally, Royal Bank Of Canada increased their price target on shares of Axsome Therapeutics from $302.00 to $304.00 and gave the company an “outperform” rating in a report on Tuesday, July 7th. Two equities research analysts have rated the stock with a Strong Buy rating, eighteen have given a Buy rating and two have assigned a Sell rating to the company. According to MarketBeat.com, the stock currently has an average rating of “Moderate Buy” and an average target price of $265.55.

Check Out Our Latest Stock Report on Axsome Therapeutics

About Axsome Therapeutics (Free Report)

Axsome Therapeutics, Inc is a clinical-stage biopharmaceutical company dedicated to developing novel therapies for central nervous system (CNS) disorders. The company focuses on small-molecule drugs designed to address unmet medical needs in areas such as depression, migraine, narcolepsy and fibromyalgia. Axsome employs a precision medicine approach, leveraging pharmacologic innovation to target underlying mechanisms of disease and improve patient outcomes.

Axsome’s pipeline includes several late-stage and approved product candidates.

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The market expects Axsome Therapeutics (AXSM - Free Report) to deliver a year-over-year decline in earnings on higher revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.

The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on August 10. On the other hand, if they miss, the stock may move lower.

While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise.

Zacks Consensus EstimateThis biopharmaceutical company is expected to post quarterly loss of $0.99 per share in its upcoming report, which represents a year-over-year change of -7.6%.

Revenues are expected to be $224.52 million, up 49.6% from the year-ago quarter.

Estimate Revisions TrendThe consensus EPS estimate for the quarter has been revised 14.78% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period.

Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change.

Price, Consensus and EPS Surprise

Earnings WhisperEstimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core.

The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier.

Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only.

A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP.

Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell).

How Have the Numbers Shaped Up for Axsome?For Axsome, the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +12.69%.

On the other hand, the stock currently carries a Zacks Rank of #4.

So, this combination makes it difficult to conclusively predict that Axsome will beat the consensus EPS estimate.

Does Earnings Surprise History Hold Any Clue?Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number.

For the last reported quarter, it was expected that Axsome would post a loss of$0.85 per share when it actually produced a loss of -$1.26, delivering a surprise of -48.24%.

Over the last four quarters, the company has beaten consensus EPS estimates just once.

Bottom LineAn earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss.

That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported.

Axsome doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release.

An Industry Player's Expected ResultsAmong the stocks in the Zacks Medical - Biomedical and Genetics industry, Cytokinetics (CYTK - Free Report) , is soon expected to post loss of $1.63 per share for the quarter ended June 2026. This estimate indicates a year-over-year change of -45.5%. This quarter's revenue is expected to be $20.42 million, down 69.4% from the year-ago quarter.

The consensus EPS estimate for Cytokinetics has been revised 0.3% higher over the last 30 days to the current level. However, a higher Most Accurate Estimate has resulted in an Earnings ESP of +2.07%.

When combined with a Zacks Rank of #3 (Hold), this Earnings ESP indicates that Cytokinetics will most likely beat the consensus EPS estimate. Over the last four quarters, the company surpassed consensus EPS estimates two times.

Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar.

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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.

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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.

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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.

More From ForbesForbesThe KC Current Are Ready To Expand Their Pioneering Soccer StadiumBy Brett KnightForbesAmerica’s Richest Families: From Waltons To Rockefellers, These Are The 54 RichestBy Matt DurotForbesAmerica’s Biggest Cannabis Greenhouse Wants To Become ‘The Sunkist Of Weed’By Will Yakowicz

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.