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Key Takeaways Axsome's Auvelity generated $333 million in first-half 2026 sales, up 54.2% year over year.Auvelity's Alzheimer's agitation launch and phase III smoking cessation study could expand its market reach.AXSM's acquisition of Sunosi's U.S. rights from Jazz helped diversify its commercial portfolio.
Axsome Therapeutics (AXSM - Free Report) has been witnessing strong uptake for its lead marketed drug, Auvelity (AXS-05), which is approved for treating major depressive disorder. The drug has played an instrumental role in driving the company’s top line since its approval and launch in the United States in 2022.

Auvelity generated $333 million in sales in the first half of 2026, up 54.2% year over year in the United States. Building on this momentum, we expect investors to closely watch Auvelity’s sales performance when Axsome reports its third-quarter 2026 results on Nov. 2.

Auvelity sales are likely to have been driven by prescription growth and higher volumes during the third quarter.

The drug is also being developed in several label expansion studies for other central nervous system (CNS) disorders like Alzheimer’s disease agitation and smoking cessation.

In April 2026, the FDA approved Auvelity for the treatment of agitation associated with dementia due to Alzheimer’s disease. The company commercially launched Auvelity for this indication in June 2026.

Axsome recently initiated the phase III SUMMIT study evaluating Auvelity for smoking cessation in August 2026.

The successful commercialization of Auvelity in additional indications would help the drug address a broader patient population and drive sales further in future quarters.

AXSM’s Other Marketed Drugs Support GrowthBesides Auvelity, Axsome’s narcolepsy drug, Sunosi (solriamfetol), is also generating incremental sales and aiding the top line. Axsome acquired U.S. rights to Sunosi from Jazz Pharmaceuticals (JAZZ - Free Report) .

Sunosi generated sales worth $66.5 million in the first half of 2026, reflecting an increase of 25.5% year over year. The acquisition of Sunosi from Jazz diversified Axsome’s commercial portfolio. The drug has become an important revenue driver for the company.

Axsome’s newest product, Symbravo, was approved by the FDA for the acute treatment of migraine with or without aura in adults in January 2025. The drug, which was launched in the United States in June 2025, recorded sales worth $6.3 million in the first six months of 2026.

The approval of Symbravo further solidified Axsome’s commercial footprint in the target market. However, increasing competition in the target market remains a concern for the company.

AXSM’s Competition in the Target MarketAlthough Axsome is benefiting from Auvelity’s momentum and its broader commercial portfolio, the CNS space remains highly competitive. Acadia Pharmaceuticals (ACAD - Free Report) currently markets its lead drug, Nuplazid (pimavanserin), for a CNS disorder.

ACAD’s Nuplazid was the first and only drug approved by the FDA for hallucinations and delusions associated with Parkinson’s disease psychosis. The ACAD drug recorded sales worth $350.1 million in first-half 2026, up 7% year over year.

Sunosi is also likely to face competition from Jazz’s sleep disorder drugs, which hold a strong market share.

Symbravo is also expected to face stiff competition in the migraine market from established players such as Pfizer’s Nurtec ODT/Vydura and AbbVie’s Ubrelvy and Qulipta/Aquipta. This could intensify competition for Axsome and potentially affect its long-term growth prospects.

 | Source: Axsome Therapeutics, Inc.

NEW YORK, Oct. 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 it will report its financial results for the third quarter of 2026 on Monday, November 2, 2026, before the opening of the U.S. financial markets. Axsome management will then host a conference call at 8:00 a.m. Eastern Time to discuss these results and provide a business update.

To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic) or +1 (201) 389-0851 (international). A live webcast of the conference call can be accessed on the “Webcasts & Presentations” page of the “Investors” section of the Company’s website at www.axsome.com. A replay of the conference call will be available on the Company’s website for approximately 30 days following the live 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, and multiple early- to 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]

 | Source: Axsome Therapeutics, Inc.

The Shared Goals: Navigating Alzheimer’s Agitation survey finds that Alzheimer’s disease agitation is often only recognized after daily life is significantly disrupted

Ninety-seven percent of care partners reported that agitation negatively impacted their loved one’s quality of life, and three in four wish they had recognized symptoms sooner

Results from the survey were recently presented at Psych Congress 2026 in New Orleans, Louisiana

Survey conducted by The Harris Poll and in collaboration with CaringKind

NEW YORK, Sept. 21, 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, in connection with World Alzheimer’s Day, announced results of the Shared Goals: Navigating Alzheimer's Agitation survey that highlight the profound impact that symptoms of agitation can have on people with Alzheimer’s disease and their family care partners.

The Shared Goals survey of 751 adults who currently provide care to a loved one with Alzheimer’s disease was conducted online by The Harris Poll, with input from CaringKind, a leading expert on Alzheimer’s and dementia caregiving with over 40 years of experience, and sponsored by Axsome. It is among the largest and most recent surveys of care partners of people living with Alzheimer’s disease agitation. The Shared Goals survey results were presented at Psych Congress 2026 in New Orleans, Louisiana, on September 17 and 18, 2026.

“These survey findings give important insights into why there is such a delay in recognition of symptoms of agitation. Because the behaviors doing the most damage can be mistaken for personality changes or disease progression, they often go unaddressed until daily life is significantly disrupted,” said Brent P. Forester, M.D., psychiatrist-in-chief and chair of the Department of Psychiatry at Tufts Medical Center and director of Behavioral Health for Tufts Medicine. “Recognizing these behaviors early and discussing them with a healthcare provider allows families and clinicians to set shared goals for care and discuss treatment options, which may help them manage agitation before it becomes too overwhelming to them.”

Care partners surveyed reported that agitation negatively affected their loved one’s overall quality of life (97%), ability to care for themselves (96%), community engagement (95%) and maintaining relationships with family and friends (89%). While 85% of care partners reported being highly involved in treatment decisions, recognition often comes too late, with 76% wishing they had recognized symptoms of agitation sooner and 53% regretting not talking to their loved one’s healthcare provider sooner about their agitation symptoms.

The survey also revealed that the symptoms of Alzheimer’s disease that are most detrimental to a loved one’s overall quality of life are nonaggressive symptoms of agitation, such as complaining, negativism, frequent unwarranted requests for help (76%); repetitive sentences or questions, inappropriate laughter or crying (75%); repetitive mannerisms (67%); and pacing or aimless wandering (56%).  

Care partners also expressed a desire for resources to help manage their loved ones’ symptoms of agitation: 89% wished they had an easier way to track their loved one’s symptoms of agitation over time, and 81% expressed interest in a way to easily and discreetly share information about such symptoms with their loved ones’ doctor. Care partners also described unmet needs in managing agitation, with nearly half (47%) worried if they are making the right medication decisions for their loved ones. Further, 93% of care partners said they wish there was a medication that reduced their loved one's symptoms of agitation without adding negative side effects.

Additional survey results and more information on Alzheimer’s disease agitation can be found by visiting ALZGoals.com.  

Survey Methodology

The Harris Poll, on behalf of Axsome Therapeutics, Inc., conducted an online survey among 751 adults age 18+ in the U.S. who currently provide informal (i.e., unpaid or unprofessional) care to a loved one with Alzheimer’s disease, between October 7 – 28, 2025. For complete survey methodology, including weighting variables, sample definition/details, subgroup sample sizes, and credible interval, please contact [email protected].

About Agitation Associated with Dementia Due to Alzheimer’s Disease

Alzheimer’s disease is the most common form of dementia affecting more than 7 million people in the U.S.1 Agitation associated with dementia due to Alzheimer’s disease is a neuropsychiatric condition reported in up to 75% of patients with Alzheimer’s disease and is characterized by emotional distress, verbal and physical aggressiveness, disruptive irritability and disinhibition.1,2 The exact cause of agitation in the brain is not known but it is associated with changes in glutamate and monoamine signaling.3,4 Agitation has been associated with accelerated cognitive decline, increased caregiver burden and increased mortality risk and is a leading cause of assisted living or nursing home placement.5

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 agitation associated with dementia due to Alzheimer’s disease, major depressive disorder, 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:

Alzheimer’s Disease Facts and Figures. Alzheimer’s Association. July 22, 2026. https://www.alz.org/alzheimers-dementia/facts-figures.Van der Mussele S, Le Bastard N, Saerens J, et al. Agitation-associated behavioral symptoms in mild cognitive impairment and Alzheimer's dementia. Aging Ment Health. 2015;19(3):247-257.Cummings JL, Brubaker M, Selzler KJ, Gonzalez ST, Patel M, Stahl SM. An overview of the pathophysiology of agitation in Alzheimer's dementia with a focus on neurotransmitters and circuits. CNS Spectr. 2024;23:1-10.Rosenberg PB, Nowrangi MA, Lyketsos CG. Neuropsychiatric symptoms in Alzheimer's disease: What might be associated brain circuits? Mol Aspects Med. 2015;43-44:25-37.Porsteinsson AP, Antonsdottir IM. An update on the advancements in the treatment of agitation in Alzheimer's disease. Expert Opin Pharmacother. 2017;18(6):611-620.

Axsome Therapeutics (NASDAQ:AXSM) executives highlighted growth across its commercial portfolio, an expanded sales force and multiple late-stage clinical programs during the H.C. Wainwright 28th Annual Global Investment Conference.

Chief Operating Officer Mark Jacobson said the company has three marketed products: Auvelity for major depressive disorder and Alzheimer’s disease agitation; Sunosi for excessive daytime sleepiness associated with obstructive sleep apnea or narcolepsy; and SYMBRAVO for the acute treatment of migraine. The company also has six product candidates in development across 10 psychiatry and neurology indications, he said.

Chief Financial Officer Nick Pizzie said Axsome reported second-quarter revenue of $218.4 million, representing 46% year-over-year growth and 14% sequential growth. Auvelity generated more than $180 million of that total, while Sunosi contributed $36 million and SYMBRAVO produced $2.3 million. Auvelity Growth and Alzheimer’s Disease Agitation Launch Executives emphasized Auvelity’s commercial opportunity following its recently approved indication for agitation associated with Alzheimer’s disease. Jacobson said the launch began in the summer and became more fully operational in June, alongside the completion of an expansion of the company’s community sales force.

Pizzie said Axsome expanded its sales organization from fewer than 300 representatives to more than 600, or roughly 630 when including its long-term-care team. The company added the long-term-care-focused team after receiving the Alzheimer’s disease agitation indication, according to Jacobson.

“We expect to see that growth begin essentially now,” Jacobson said, referring to expected effects from the field-force expansion, market-access developments and the new indication.

Pizzie said the company estimates Auvelity’s annual peak-sales potential at more than $8 billion, split roughly between major depressive disorder and Alzheimer’s disease agitation. He said the product’s annualized revenue based on second-quarter results was about $750 million, representing what he characterized as a small share of the broader antidepressant market.

The company said all Medicare Part D participants have access to Auvelity for Alzheimer’s disease agitation, with more than 85% of patients not requiring prior authorization and having unrestricted or first-line access, according to Pizzie.

Other Commercial Products Sunosi, which Axsome acquired and markets for excessive daytime sleepiness in narcolepsy and obstructive sleep apnea, continues to grow steadily, Jacobson said. Pizzie cited estimated peak-sales potential of $300 million to $500 million for the product.

For SYMBRAVO, Pizzie said revenue rose 30% sequentially in the second quarter. Executives said demand and feedback have been positive, while payer access remains an important factor in the migraine market. Axsome increased the SYMBRAVO sales team from about 100 representatives to 150 representatives, with the impact of the additional personnel not yet reflected in the cited growth figures.

The company estimates SYMBRAVO could have annual peak sales of $500 million to $1 billion, Pizzie said.

Pipeline Milestones and Financial Position Axsome has an NDA under FDA review for AXS-12 in narcolepsy, with a Prescription Drug User Fee Act date of May 1, Jacobson said. The company also recently initiated a Phase 3 smoking-cessation study of AXS-05, called SUMMIT, and two Phase 3 studies of solriamfetol in children and adolescents with ADHD, called FOCUS-2 and FOCUS-3.

Top-line results from the Phase 3 ENGAGE trial of solriamfetol in binge eating disorder are expected in the fourth quarter, Jacobson said. The company expects top-line results from a shift-work-disorder trial of sarampanadol next year.

Seven clinical trials are ongoing, according to Axsome. The company is also pursuing programs in fibromyalgia, major depressive disorder with excessive sleepiness, schizophrenia, epilepsy and Tourette syndrome. Executives said they see the potential for approximately one NDA filing annually for the foreseeable future through 2031. Pizzie said Axsome ended the second quarter with $320 million in cash, which he described as the company’s strongest financial position since inception. The company reported $46 million of research and development expense and $208 million of selling, general and administrative expense during the quarter.

Axsome expects selling, general and administrative spending to remain essentially level in the second half of the year, while research and development expense is expected to rise modestly as Phase 3 programs advance, Pizzie said. He added that the company is approaching cash-flow positivity and expects profitability to follow.

Jacobson also highlighted the company’s intellectual-property position, saying Auvelity exclusivity is expected to extend to early 2039 with pediatric exclusivity, while Sunosi’s established runway extends into 2040. He said SYMBRAVO patents extend to at least 2045, with work ongoing to establish its potential exclusivity period.

About Axsome Therapeutics (NASDAQ:AXSM) Axsome Therapeutics, Inc is a biopharmaceutical company focused on developing and commercializing therapies for central nervous system (CNS) disorders. The company’s research programs address conditions with substantial unmet medical needs, including depression, migraine, narcolepsy, excessive daytime sleepiness, agitation associated with Alzheimer’s disease, and other neurological or psychiatric disorders.

Axsome’s commercial portfolio includes Auvelity, an oral medicine approved in the United States for the treatment of major depressive disorder in adults.

Bank of America Corp DE bought a new stake in Axsome Therapeutics, Inc. (NASDAQ:AXSM – Free Report) during the second quarter, according to the company in its most recent 13F filing with the SEC. The institutional investor bought 452,491 shares of the company’s stock, valued at approximately $110,756,000. Bank of America Corp DE owned approximately 0.86% of Axsome Therapeutics as of its most recent filing with the SEC.

A number of other hedge funds have also bought and sold shares of the company. Hollencrest Capital Management grew its position in shares of Axsome Therapeutics by 400.0% during the 1st quarter. Hollencrest Capital Management now owns 200 shares of the company’s stock valued at $34,000 after buying an additional 160 shares during the last quarter. ABS Investment Management LLC bought a new position in Axsome Therapeutics in the second quarter worth about $171,339,000. Silvant Capital Management LLC acquired a new position in Axsome Therapeutics in the second quarter valued at approximately $66,000. GAMMA Investing LLC grew its holdings in shares of Axsome Therapeutics by 14.9% during the second quarter. GAMMA Investing LLC now owns 347 shares of the company’s stock valued at $85,000 after purchasing an additional 45 shares during the last quarter. Finally, Northwestern Mutual Wealth Management Co. bought a new position in shares of Axsome Therapeutics during the second quarter valued at approximately $98,000. 81.49% of the stock is currently owned by institutional investors and hedge funds.

Axsome Therapeutics Stock Performance Shares of Axsome Therapeutics stock opened at $207.78 on Friday. Axsome Therapeutics, Inc. has a 12 month low of $114.91 and a 12 month high of $260.19. The company has a quick ratio of 1.34, a current ratio of 1.43 and a debt-to-equity ratio of 1.52. The stock has a market cap of $10.88 billion, a PE ratio of -55.41 and a beta of 0.71. The business has a fifty day simple moving average of $217.33 and a 200-day simple moving average of $209.97.

Axsome Therapeutics (NASDAQ:AXSM – Get Free Report) last announced its quarterly earnings data on Monday, August 10th. The company reported ($0.99) earnings per share (EPS) for the quarter, missing the consensus estimate of ($0.89) by ($0.10). Axsome Therapeutics had a negative return on equity of 265.55% and a negative net margin of 24.68%.The business had revenue of $218.38 million during the quarter, compared to analysts’ expectations of $221.11 million. On average, sell-side analysts anticipate that Axsome Therapeutics, Inc. will post -2.8 EPS for the current fiscal year. Analysts Set New Price Targets Several analysts recently issued reports on the company. TD Cowen raised their price target on Axsome Therapeutics from $275.00 to $300.00 and gave the stock a “buy” rating in a report on Wednesday, June 17th. Weiss Ratings reaffirmed a “sell (d-)” rating on shares of Axsome Therapeutics in a research report on Friday, July 17th. Morgan Stanley raised their target price on Axsome Therapeutics from $242.00 to $251.00 and gave the company an “equal weight” rating in a research note on Tuesday, August 11th. UBS Group restated a “buy” rating on shares of Axsome Therapeutics in a research report on Monday, August 24th. Finally, Piper Sandler reaffirmed an “overweight” rating and issued a $258.00 price objective on shares of Axsome Therapeutics in a report on Friday. Two equities research analysts have rated the stock with a Strong Buy rating, seventeen have issued a Buy rating, two have issued a Hold rating and one has assigned a Sell rating to the stock. According to MarketBeat.com, the company presently has a consensus rating of “Moderate Buy” and a consensus price target of $267.60.

Read Our Latest Research Report on AXSM

Insider Buying and Selling at Axsome Therapeutics In other news, COO Mark L. Jacobson sold 10,000 shares of Axsome Therapeutics stock in a transaction dated Thursday, September 3rd. The stock was sold at an average price of $208.65, for a total transaction of $2,086,500.00. Following the completion of the sale, the chief operating officer directly owned 10,000 shares in the company, valued at $2,086,500. The trade was a 50.00% decrease in their position. The sale was disclosed in a filing with the Securities & Exchange Commission, which can be accessed through this link. Also, CEO Herriot Tabuteau sold 4,660 shares of the business’s stock in a transaction that occurred on 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 sale, the chief executive officer directly owned 7,229 shares of the company’s stock, valued at approximately $1,546,644.55. The trade was a 39.20% decrease in their position. The SEC filing for this sale provides additional information. Over the last quarter, insiders have sold 109,330 shares of company stock valued at $24,557,062. 20.60% of the stock is owned by corporate insiders.

(Free Report)

Axsome Therapeutics, Inc is a biopharmaceutical company focused on developing and commercializing therapies for central nervous system (CNS) disorders. The company’s research programs address conditions with substantial unmet medical needs, including depression, migraine, narcolepsy, excessive daytime sleepiness, agitation associated with Alzheimer’s disease, and other neurological or psychiatric disorders.

Axsome’s commercial portfolio includes Auvelity, an oral medicine approved in the United States for the treatment of major depressive disorder in adults.

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Axsome Therapeutics (AXSM -3.03%) has been a great stock to own over the past five years. The company's shares have climbed by about 660%. However, Wall Street remains excited about the company's prospects. Axsome Therapeutics' average price target (according to Yahoo! Finance) is $285.42, implying a 35% upside from its current level. Could the stock really gain that much over the next 12 months?

Image source: The Motley Fool.

Multiple catalysts on the horizon Axsome Therapeutics is posting solid financial results. In the second quarter, the company's revenue increased by 46% year over year to $218.4 million. The biotech's most important growth driver by far is Auvelity, a depression medicine. Second-quarter Auvelity sales came in at $180.3 million, 51% higher than the year-ago period. Auvelity recently earned a label expansion in Alzheimer's disease (AD) agitation, an indication that adds millions of patients in an underserved and growing therapeutic area to its addressable market.

Axsome Therapeutics also markets Sunosi, a medicine for daytime sleepiness due to narcolepsy, and Symbravo, a migraine treatment. Further, over the next year, the company should make meaningful clinical and regulatory progress. Axsome Therapeutics is running a Phase 3 clinical trial of AXS-14 for fibromyalgia and is preparing Phase 3 studies for AXS-20 in schizophrenia. In addition, the drugmaker could earn approval for AXS-12 to treat narcolepsy by May of next year.

If Axsome Therapeutics can achieve significant clinical trial wins and launch a brand-new product over the next year, the stock could climb meaningfully. Under a bullish scenario, a 35% gain over the next 12 months is not out of the question.

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Moneyball Superscore

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The more important question That said, it's always difficult to predict which way any stock will move in the near term. Even with Axsome Therapeutics' upcoming catalysts in mind, broader equity market challenges or company-specific headwinds -- such as regulatory setbacks -- could sink the stock. But what do Axsome Therapeutics' medium-term prospects look like? The biotech has an attractive late-stage pipeline, with several products that could either post Phase 3 clinical trial results or earn approval within the next three years.

While a single setback could significantly impact Axsome Therapeutics' performance over the next 12 months, the picture changes once we expand our timeline five years into the future. Axsome Therapeutics' pipeline is deep enough to handle some clinical trial failures and still perform well over this period. In fact, since 2021, the company has faced a few headwinds and has still crushed broader equities.

Even assuming, for the sake of argument, that half of its ongoing late-stage clinical trials succeed, Axsome Therapeutics could have at least a couple of new products (or label expansions) by the end of the decade, and we haven't even considered the company's Phase 2 clinical programs, which should also make progress. Meanwhile, Axsome Therapeutics' revenue should continue to grow at a good clip as it makes progress in large markets such as AD agitation.

So, my view is that Axsome Therapeutics is well-positioned to deliver competitive returns through 2031, even if it falls short of the Street's price target within a year.

Axsome Therapeutics (AXSM +1.09%) has seen its stock price climb over the past few years -- and for good reason. The company has progressively launched new products, confirming its expertise in the neuroscience space. This biotech aims to treat a variety of conditions linked to central nervous system (CNS) operations, from depression to migraine and narcolepsy.

All of this helped the stock advance 180% over three years, as investors got excited about new product approvals, pipeline progress, and double-digit revenue growth. But, in recent times, Axsome shares have pulled back, falling about 15% over the past three months. Is it too late to get in on this hot healthcare stock -- or is it a buy on the dip? Let's find out.

Image source: Getty Images.

A central nervous system specialistFirst, let's consider Axsome's story so far. The biopharma company specializes in CNS conditions and is targeting several through currently marketed products as well as candidates in the pipeline. The company has three commercialized drugs, starting with its lead product, Auvelity, approved for major depressive disorder in 2022 and, more recently, approved for agitation associated with Alzheimer's disease. That drug's sales jumped more than 50% in the recent quarter to about $180 million, and it's making important progress in the Alzheimer's agitation indication.

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Moneyball Superscore

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$

214.28

Auvelity launched into the Alzheimer's market in June, and in the first eight weeks to follow, new-to-brand prescriptions among adults ages 65 and older increased 126% compared with the same period in the previous quarter. So the Alzheimer's indication immediately broadened the drug's revenue opportunity. And the number of Auvelity prescriptions written in the quarter, up 34% year-over-year to 266,000, confirms this.

Meanwhile, Sunosi, the company's treatment for excessive daytime sleepiness associated with narcolepsy or sleep apnea, saw a 14% year-over-year increase in prescriptions to 61,000. And that drug generated net product revenue, including product sales and royalties, of more than $35 million.

Finally, Symbravo, a migraine treatment that launched in June of last year, saw a 30% increase in prescriptions from the first quarter to 23,500. And sales surged more than 400% to $2.3 million. It's important to note that Symbravo is in the early stages of its growth story, as payer coverage is at 57% -- there's room for expansion -- and the company is completing additions to its Symbravo sales force. A larger sales force will help the company reach further into the primary care and specialist communities.

Five phase 3 programsWhile these three drugs are powering revenue growth, Axsome isn't sitting still. The company has five phase 3 programs -- in attention deficit and hyperactivity disorder, major depressive disorder, binge eating disorder, shift work disorder, and fibromyalgia -- ongoing. And Axsome is awaiting a regulatory decision on its narcolepsy candidate -- regulators are expected to decide by May of next year. All of this suggests new revenue drivers may be near.

So, a lot is going on at Axsome, and these recent launches and late-stage trials could lead to significant growth over the next few years. This means now could be a very exciting time to own Axsome stock.

But, is it too late to buy? No -- this story is just beginning, and potential catalysts of revenue growth and product approvals could push the stock higher in the quarters to come. Meanwhile, the fact that Axsome has three commercialized products generating revenue makes it less of a risky bet than a company without products on the market. And Axsome recently said that it expects its current cash to fund operations into cash flow positivity. This is another element that lowers risk for shareholders.

So, when you buy Axsome stock, you're getting in on an innovative biopharma company -- something growth investors like -- but the company also offers you elements of safety, such as a portfolio of revenue-generating products and a healthy financial picture. This makes it a stock cautious investors may consider too.

All of this means that Axsome is a great stock to buy today on the dip -- and hold onto as new and possibly future drugs drive growth.

Axsome Therapeutics, Inc. (AXSM) H.C. Wainwright 28th Annual Global Investment Conference September 16, 2026 10:00 AM EDT

Company Participants

Mark Jacobson - Chief Operating Officer
Nick Pizzie - Chief Financial Officer

Presentation

Operator

Good morning, everyone, and welcome to the H.C. Wainwright 28th Annual Global Investment Conference. I'm [ Katherine Dagan ], and I'll be your moderator for today. It's our pleasure to welcome Mark Jacobson, COO; and Nick Pizzie, CFO of Axsome Therapeutics. Thank you both for being here. Take it away.

Mark Jacobson
Chief Operating Officer

Great. Thanks very much for having us, and good morning, everyone. Nice to be here and see you all. So we're actually going to take you through today and the corporate presentation instead of a fireside chat, we want to take a moment to really share how the business has grown and where it is in this very, I think, unique stage of development that we're pretty excited about.

First and foremost, we will be making forward-looking statements today or we may be, and we'd encourage you to read a full summary of the risks and uncertainties associated with our business through our filings at the Securities and Exchange Commission.

So with that, we'll get started. So Axsome Therapeutics, we are focused on central nervous system disorders, in particular, highly differentiated mechanisms of actions for areas of unmet need or that have been underserved in CNS. And that's -- we think about it for psychiatry and neurology. And the snapshot of the business today is 3 marketed products, Auvelity, Sunosi and SYMBRAVO. Auvelity is approved for major depressive disorder and recently, Alzheimer's disease agitation, which we are launching now, Sunosi for excessive daytime sleepiness in OSA or narcolepsy and then SYMBRAVO for migraine.

We'll talk more about each of those. We have 6

Axsome Therapeutics, Inc. (AXSM) Presents at 12th Annual Cantor Fitzgerald Global Healthcare Conference Transcript

It has been about a month since the last earnings report for Axsome Therapeutics (AXSM - Free Report) . Shares have lost about 3.7% in that time frame, underperforming the S&P 500.

Will the recent negative trend continue leading up to its next earnings release, or is Axsome due for a breakout? Well, first let's take a quick look at the most recent earnings report in order to get a better handle on the recent drivers for Axsome Therapeutics, Inc. before we dive into how investors and analysts have reacted as of late.

Axsome's Q2 Earnings Meet Estimates, Auvelity Drives Y/Y RevenuesAxsome 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 as well as other marketed drugs. The top line, however, missed the Zacks Consensus Estimate of $225 million.

Quarter in DetailTotal revenues in the second quarter consisted of product revenues from Auvelity, Sunosi and the newest drug, Symbravo, 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’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.

How Have Estimates Been Moving Since Then?Since the earnings release, investors have witnessed a downward trend in fresh estimates.

VGM ScoresCurrently, Axsome has a nice Growth Score of B, 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 D. 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.

Performance of an Industry PlayerAxsome belongs to the Zacks Medical - Biomedical and Genetics industry. Another stock from the same industry, Puma Biotech (PBYI - Free Report) , has gained 7.1% over the past month. More than a month has passed since the company reported results for the quarter ended June 2026.

Puma Biotech reported revenues of $56.5 million in the last reported quarter, representing a year-over-year change of +7.8%. EPS of $0.19 for the same period compares with $0.15 a year ago.

For the current quarter, Puma Biotech is expected to post earnings of $0.11 per share, indicating a change of -47.6% from the year-ago quarter. The Zacks Consensus Estimate has changed -45.5% over the last 30 days.

The overall direction and magnitude of estimate revisions translate into a Zacks Rank #3 (Hold) for Puma Biotech. Also, the stock has a VGM Score of A.

Key Takeaways Axsome dosed the first patient in the phase III SUMMIT study evaluating AXS-05 for smoking cessation.SUMMIT study will compare AXS-05, bupropion and placebo in adult smokers over approximately 12 weeks.The study's primary endpoint is smoking abstinence at the end of the 12-week treatment period. Axsome Therapeutics (AXSM - Free Report) announced that it has dosed the first patient in the phase III SUMMIT study evaluating AXS-05 for the treatment of smoking cessation.

The randomized, double-blind, placebo-controlled phase III SUMMIT study is designed to assess the safety and efficacy of AXS-05 for treating smoking cessation in adults. In the study, active smokers will be randomized to receive AXS-05, bupropion, or placebo in a 1:1:1 ratio for approximately 12 weeks.

The primary endpoint of the SUMMIT study is to check smoking abstinence at the end of the 12-week treatment period.

Axsome currently markets AXS-05 under the trade name Auvelity in the United States 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 increased 8.7% compared with the industry’s rise of 9.7%.

Image Source: Zacks Investment Research

Auvelity Drives Axsome’s Revenue SurgeAxsome’s lead drug, Auvelity, has been witnessing strong uptake. The drug has played an instrumental role in driving the company’s top line since its approval and launch in the United States in 2022. Sales of the drug have been rising consistently owing to strong demand.

Auvelity generated sales worth $333 million in the first half of 2026, increasing 54.2% year over year in the United States. The drug’s sales are being driven by prescription growth and higher volumes and the momentum is likely to continue in the rest of 2026.

The successful commercialization of Auvelity in additional indications would help the drug address a broader patient population and drive sales further in future quarters.

Besides Auvelity, Axsome’s narcolepsy drug, Sunosi (solriamfetol), is also generating incremental sales and aiding the top line. Axsome acquired U.S. rights to Sunosi from Jazz Pharmaceuticals (JAZZ - Free Report) .

The acquisition of Sunosi from Jazz diversified the company’s commercial portfolio.

Sunosi generated sales worth $66.5 million in the first half of 2026, reflecting an increase of 25.5% year over year. The drug has become an important revenue driver for Axsome.

Axsome’s newest product, Symbravo, was approved by the FDA for the acute treatment of migraine with or without aura in adults in January 2025. The drug was launched in the United States in June 2025. Symbravo recorded sales worth $6.3 million in the first six months of 2026. The approval further diversified Axsome’s commercial portfolio.

AXSM’s Zacks Rank & Stocks to ConsiderAxsome currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Repligen (RGEN - Free Report) and Anika Therapeutics (ANIK - Free Report) , both sporting a Zacks Rank #1 (Strong Buy) at present. 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 $2.61 during the same time. RGEN’s shares have gained 10.5% 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 Anika Therapeutics’ 2026 earnings per share have risen from 41 cents to $1.05, while estimates for 2027 have increased from 46 cents to 95 cents during the same time. ANIK’s shares have surged 117.2% year to date.

Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950.00%.

Choosing between Amgen (AMGN -1.05%) and Axsome Therapeutics (AXSM -3.52%) means weighing the established stability of a global pharmaceutical leader against the rapid growth of an emerging central nervous system specialist.

Amgen operates as a diversified biotechnology giant with products reaching patients in approximately 100 countries. Axsome Therapeutics focuses on central nervous system disorders like depression and narcolepsy. While Amgen relies on its massive scale and cash generation, Axsome is currently prioritizing the commercialization of its newer therapies to reach long-term profitability.

The case for AmgenAmgen discovers and delivers medicines for serious diseases across several core areas, including inflammation, rare disease, and oncology. Its massive scale allows it to distribute products to roughly 100 countries, though McKesson (MCK +0.32%), Cencora (COR +0.25%), and Cardinal Health (CAH -0.25%) accounted for 77% of its fiscal 2025 revenue. Customer concentration like this adds a layer of risk, even if it is common among major biotech stocks.

In FY 2025, revenue reached nearly $36.7 billion, an increase of approximately 9.9% year over year. The company reported net income of roughly $7.7 billion, showing significant growth from the $4.1 billion earned in 2024. This resulted in a net margin of 21%, which is a measure of profitability that shows how much of each dollar of revenue is converted into profit.

As of Amgen's December 2025 balance sheet, the debt-to-equity ratio is 6.3, meaning total debt is more than six times the value of shareholder equity. The current ratio, which measures the ability to pay short-term obligations using current assets, is approximately 1.1. Free cash flow for the year reached nearly $8.1 billion, representing the cash a company generates after accounting for the money spent to maintain or expand its asset base.

The case for Axsome TherapeuticsAxsome Therapeutics is a biopharmaceutical company specializing in therapies for central nervous system conditions, such as migraine and major depressive disorder. It leverages strategic partnerships to expand its global reach, including research collaborations with major industry players like Pfizer (PFE -0.21%) and AstraZeneca (AZN -1.11%). The company currently markets its portfolio in the United States and works with partners to expand into European markets.

In fiscal 2025, revenue increased by approximately $638.5 million, skyrocketing 65.5% year over year. Despite this strong top-line growth, Axsome reported a net loss of nearly $183.2 million as it continues to invest in its pipeline. The resulting net margin was negative 28.7%, though this was an improvement from the negative 74.5% margin seen in 2024.

As of its December 2025 balance sheet, Axsome maintains a debt-to-equity ratio of 2.7. The current ratio is approximately 1.6, indicating that current assets like cash and receivables comfortably cover short-term liabilities. Free cash flow was negative $93.9 million for the year, which is typical for biotechs that are still scaling their commercial operations.

Risk profile comparisonAmgen faces significant pricing pressure from government and commercial payers, specifically due to Medicare price setting for key products like ENBREL and Otezla. The company also deals with ongoing patent litigation and manufacturing concentration in Puerto Rico, which is historically susceptible to natural disasters. Furthermore, cybersecurity remains a concern after previous incidents involving third-party vendors and data exfiltration.

Axsome Therapeutics relies on a relatively small product portfolio and has an accumulated deficit of nearly $1.3 billion as of the end of 2025. Much of its intellectual property is licensed from an entity owned by its CEO and chairman, which creates potential conflicts of interest and dependency on these specific agreements. The company also faces generic competition risks and the ongoing need for significant capital to fund clinical trials.

Valuation comparisonAmgen currently trades at a significantly lower valuation than Axsome Therapeutics based on both forward P/E and P/S ratio multiples.

MetricAmgenAxsome TherapeuticsForward P/E19.144.5P/S ratio6.516.7Valuation metrics sourced from Financial Modeling Prep (FMP) and may differ from other data providers.

Comparing Axsome and Amgen is somewhat difficult, as these drug companies are at very different stages of development. Amgen is a mega cap with more than 45 years of experience in the industry. Axsome was founded less than a decade and a half ago and has a market cap of about $10 billion. Amgen has three dozen approved treatments, while Axsome has three. The trend holds when examining their pipelines: Axsome has 10 candidates, and Amgen has 44. Nearly 30 of Amgen's studies are in Phase 3.

In short, Amgen is a mature, established business. Increasing revenue by 10% is nothing to sneeze at, but Axsome's soaring growth is impossible to ignore -- and investors haven't, as evidenced by the stock's forward P/E. Folks are already pricing in a fair amount of continuing success at Axsome, which adds risk.

I love a Steady-Eddie company that pays a dividend, as Amgen does, but I frankly already own many of those types of businesses. I would rather buy a small position in Axsome, because while the risk is obviously higher, I think the potential reward is, too.

BlackRock Inc. bought a new position in Axsome Therapeutics, Inc. (NASDAQ:AXSM – Free Report) during the second quarter, according to the company in its most recent 13F filing with the SEC. The institutional investor bought 3,103,708 shares of the company’s stock, valued at approximately $759,695,000. BlackRock Inc. owned about 6.03% of Axsome Therapeutics at the end of the most recent reporting period.

Several other large investors have also added to or reduced their stakes in the business. Pictet Asset Management Holding SA lifted its position in shares of Axsome Therapeutics by 20.4% during the 4th quarter. Pictet Asset Management Holding SA now owns 436,063 shares of the company’s stock worth $79,643,000 after buying an additional 73,925 shares in the last quarter. Norges Bank bought a new stake in shares of Axsome Therapeutics during the 4th quarter worth $90,490,000. Axiom Investors LLC DE boosted its holdings in shares of Axsome Therapeutics by 28.7% in the 4th quarter. Axiom Investors LLC DE now owns 63,390 shares of the company’s stock worth $11,578,000 after buying an additional 14,137 shares during the last quarter. M&T Bank Corp grew its position in Axsome Therapeutics by 2,553.8% during the fourth quarter. M&T Bank Corp now owns 49,466 shares of the company’s stock valued at $8,277,000 after buying an additional 47,602 shares during the period. Finally, Legato Capital Management LLC increased its holdings in Axsome Therapeutics by 90.6% during the fourth quarter. Legato Capital Management LLC now owns 9,627 shares of the company’s stock worth $1,758,000 after buying an additional 4,576 shares during the last quarter. Institutional investors own 81.49% of the company’s stock.

Analyst Upgrades and Downgrades Several brokerages have weighed in on AXSM. Weiss Ratings reissued a “sell (d-)” rating on shares of Axsome Therapeutics in a report on Friday, July 17th. HC Wainwright reiterated a “buy” rating and issued a $290.00 price objective on shares of Axsome Therapeutics in a research report on Wednesday, July 15th. Robert W. Baird boosted their price target on shares of Axsome Therapeutics from $241.00 to $246.00 and gave the stock an “outperform” rating in a research note on Tuesday, May 5th. Mizuho raised their price objective on Axsome Therapeutics from $306.00 to $316.00 and gave the company an “outperform” rating in a report on Wednesday, August 12th. Finally, Deutsche Bank Aktiengesellschaft set a $280.00 price target on shares of Axsome Therapeutics in a research report on Tuesday, May 5th. Two research analysts have rated the stock with a Strong Buy rating, sixteen have assigned a Buy rating, three have issued a Hold rating and one has given a Sell rating to the stock. According to MarketBeat.com, Axsome Therapeutics has a consensus rating of “Moderate Buy” and a consensus target price of $267.60.

View Our Latest Report on Axsome Therapeutics Insider Buying and Selling In other Axsome Therapeutics news, Director Mark Coleman sold 6,000 shares of the firm’s stock in a transaction dated Monday, June 1st. The stock was sold at an average price of $230.30, for a total transaction of $1,381,800.00. Following the sale, the director directly owned 35,140 shares of the company’s stock, valued at $8,092,742. This trade represents a 14.58% decrease in their ownership of the stock. The transaction was disclosed in a legal filing with the Securities & Exchange Commission, which is available through the SEC website. Also, Director Susan Mahony sold 300 shares of the business’s stock in a transaction that occurred on Tuesday, June 9th. The stock was sold at an average price of $237.21, for a total value of $71,163.00. Following the completion of the transaction, the director directly owned 1,129 shares in the company, valued at approximately $267,810.09. This represents a 20.99% decrease in their ownership of the stock. The disclosure for this sale is available in the SEC filing. The sale was made to cover tax withholding obligations related to the vesting of equity awards. Insiders sold 200,766 shares of company stock worth $46,685,646 over the last ninety days. 20.60% of the stock is owned by corporate insiders.

Axsome Therapeutics Trading Down 0.1% Shares of AXSM stock opened at $207.77 on Friday. The company has a current ratio of 1.43, a quick ratio of 1.34 and a debt-to-equity ratio of 1.52. Axsome Therapeutics, Inc. has a 12-month low of $112.90 and a 12-month high of $260.19. The stock has a market capitalization of $10.88 billion, a P/E ratio of -55.41 and a beta of 0.65. The firm’s 50 day moving average is $232.13 and its 200 day moving average is $206.02.

Axsome Therapeutics (NASDAQ:AXSM – Get Free Report) last posted its earnings results on Monday, August 10th. The company reported ($0.99) earnings per share for the quarter, missing analysts’ consensus estimates of ($0.89) by ($0.10). Axsome Therapeutics had a negative net margin of 24.68% and a negative return on equity of 265.55%. The firm had revenue of $218.38 million during the quarter, compared to the consensus estimate of $221.11 million. Research analysts expect that Axsome Therapeutics, Inc. will post -2.78 earnings per share for the current year.

(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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SummaryAxsome Therapeutics, Inc. reported Q2 2026 net product revenue growth of 46% year-on-year, but rising SG&A costs mostly offset commercial gains.Auvelity drove most revenues, benefiting from a new Alzheimer's agitation indication and an expanded sales force, yet profitability remains elusive.Management reiterates an ambitious ~$8bn peak sales target for Auvelity, but the current revenue trajectory and market dynamics cast doubt on achievability.I downgrade AXSM stock to Sell, citing persistent losses, questionable commercial scalability, and a market cap not justified by near-term revenue or profit outlook.Looking for a portfolio of ideas like this one? Members of Haggerston BioHealth get exclusive access to our subscriber-only portfolios. Learn More » bowie15/iStock via Getty Images

Investment Overview Axsome Therapeutics, Inc. (AXSM), the New York-headquartered, commercial-stage pharma company, announced its Q2 2026 earnings and business updates yesterday. The stock responded with a ~4% gain, rising to ~$221 per share. Market cap valuation is $11.5bn pre-market today.

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Biotech Is Heating Up—These 2 Red-Hot Stocks Stand OutAxsome Therapeutics NASDAQ: AXSM reported second-quarter 2026 net product revenue of $218 million, up 46% from a year earlier, as sales of AUVELITY and SUNOSI increased and prescription demand for SYMBRAVO continued to build.

The company posted a net loss of $51.3 million, or $0.99 per share, compared with a net loss of $48 million, or $0.97 per share, in the second quarter of 2025. Axsome ended the quarter with approximately $320 million in cash and cash equivalents, versus $323 million at the end of 2025.

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5 medical stocks growing earnings by triple digitsChief Executive Officer Dr. Herriot Tabuteau said the quarter included commercial growth as well as regulatory and clinical progress across the company’s neuroscience pipeline. Axsome said it expects its existing cash balance to fund operations into cash-flow positivity.

AUVELITY Drives Revenue Growth AUVELITY generated $180.3 million in quarterly net product sales, rising 51% year over year and 18% sequentially. SUNOSI contributed $35.8 million in revenue, including $33.8 million in net product sales, $1.5 million in royalty revenue from out-licensed territories and $500,000 in milestone revenue.

Struggling Axsome Stock Could Bounce Back on Drug Trial SuccessSYMBRAVO recorded net product sales of $2.3 million. While that was above the $400,000 reported in the prior-year quarter, it was down $1.8 million from the first quarter of 2026. Chief Financial Officer Nick Pizzie said the sequential decline primarily reflected a prior-period adjustment and greater use of the company’s patient-service program amid demand growth.

SYMBRAVO’s gross-to-net discount reached the high-80% range during the quarter, a deviation from trend that Axsome expects to normalize for the remainder of the year. Gross-to-net discounts for AUVELITY and SUNOSI were each approximately 50%, with the company expecting improvement through the year.

Cost of revenue was $13.6 million, or 6% of total net revenue. Research and development expense declined to $46.2 million from $49.5 million a year earlier, primarily due to lower costs associated with AXS-05 and AXS-14. Selling, general and administrative expense increased to $208.1 million from $130.3 million, driven mainly by commercialization activities for AUVELITY and SYMBRAVO.

AUVELITY Expansion and Alzheimer’s Agitation Launch Axsome launched AUVELITY for Alzheimer’s disease agitation during the quarter and completed an expansion of its AUVELITY sales force. Chief Commercial Officer Ari Maizel said early launch measures pointed to accelerating demand.

During the first eight weeks after the Alzheimer’s disease agitation launch, new-to-brand prescriptions among patients age 65 and older rose 126% compared with the same period in the prior quarter. Maizel said feedback from both community and long-term-care settings had been encouraging, though management said it was too early to provide more detailed metrics by setting of care.

Overall AUVELITY new-to-brand prescriptions increased 26% from the first quarter, while total prescriptions reached roughly 266,000, up 34% year over year and 12% sequentially. Axsome said the broader antidepressant market grew 1% year over year and 2% sequentially over the same periods.

The expanded sales organization activated more than 6,800 new AUVELITY prescribers during the quarter, a 21% increase from the prior quarter, bringing total unique prescribers since launch to approximately 69,000. Maizel said primary care was the predominant source of growth during the quarter, with growth also occurring in psychiatric specialties.

AUVELITY coverage reached approximately 89% of total lives, including 82% of commercial lives and nearly all government-channel lives. The company said more than 75% of Alzheimer’s disease agitation patients do not require prior authorization, while acknowledging that requirements can vary by coverage plan.

Axsome is using free samples in community settings to allow patients and care partners to begin titration before filling a prescription. Maizel said samples are not prescriptions and are not reflected in IQVIA prescription data.

SYMBRAVO and SUNOSI Prescription Growth SYMBRAVO total prescriptions increased 30% sequentially to approximately 23,500. Axsome said its expansion to about 150 sales representatives was substantially complete and would support greater engagement with headache specialists and continued penetration in primary care.

Payer coverage for SYMBRAVO was approximately 57% of lives across channels following the addition of about 17 million covered lives in the second quarter. The company expects coverage to improve further.

SUNOSI produced approximately 61,000 total prescriptions, up 14% from a year earlier and 8% from the prior quarter. Axsome said the wake-promoting agent market declined 1% year over year and grew 2% sequentially. More than 17,000 clinicians have prescribed SUNOSI since launch, and payer coverage was approximately 82% across channels.

Pipeline Advances Include AXS-12 NDA Review The FDA accepted Axsome’s new drug application for AXS-12 for cataplexy in narcolepsy, setting a target action date of May 1, 2027. The company said AXS-12 has demonstrated onset of action at one week, durable efficacy data through six months, and potential effects on excessive daytime sleepiness and cognition, though it remains subject to FDA review.

Axsome also said it remains on track to begin a Phase II/III trial of AXS-05 for smoking cessation during the current quarter. Its solriamfetol development program includes five ongoing Phase III trials across attention-deficit/hyperactivity disorder, binge eating disorder, major depressive disorder with excessive daytime sleepiness symptoms, and excessive daytime sleepiness associated with shift work disorder.

Top-line results from the ENGAGE Phase III trial of solriamfetol in binge eating disorder are expected in the fourth quarter of 2026. Axsome recently initiated the FOCUS-2 and FOCUS-3 pediatric ADHD trials of solriamfetol. Enrollment continues in the FORWARD Phase III trial of AXS-14 for fibromyalgia. The company is advancing manufacturing work for AXS-20, or balipodect, ahead of a planned Phase III schizophrenia trial. Phase II-enabling work is also underway for AXS-17 in epilepsy. Tabuteau said the company’s late-stage pipeline could support, on average, one new NDA filing annually through 2030.

About Axsome Therapeutics (NASDAQ:AXSM)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.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].

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Should You Invest $1,000 in Axsome Therapeutics Right Now?Before you consider Axsome Therapeutics, you'll want to hear this.

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For the quarter ended June 2026, Axsome Therapeutics (AXSM - Free Report) reported revenue of $218.38 million, up 45.5% over the same period last year. EPS came in at -$0.99, compared to -$0.92 in the year-ago quarter.

The reported revenue represents a surprise of -2.74% over the Zacks Consensus Estimate of $224.52 million. With the consensus EPS estimate being -$0.99, the company has not delivered EPS surprise.

While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wall Street expectations to determine their next course of action, some key metrics always provide a better insight into a company's underlying performance.

Since these metrics play a crucial role in driving the top- and bottom-line numbers, comparing them with the year-ago numbers and what analysts estimated about them helps investors better project a stock's price performance.

Here is how Axsome performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts:

Revenues- Product sales, net: $216.36 million versus $222.61 million estimated by six analysts on average. Compared to the year-ago quarter, this number represents a +45.2% change.Revenues- Royalty revenue and milestone revenue: $2.02 million versus $1.4 million estimated by five analysts on average. Compared to the year-ago quarter, this number represents a +86.5% change.Product Sales, net- SYMBRAVO: $2.3 million versus the four-analyst average estimate of $7.19 million.Product Sales, net- Auvelity: $180.3 million compared to the $174.71 million average estimate based on four analysts. The reported number represents a change of +50.8% year over year.Product Sales, net- Sunosi: $35.8 million versus the four-analyst average estimate of $33.79 million. The reported number represents a year-over-year change of +19.3%.View all Key Company Metrics for Axsome here>>>

Shares of Axsome have returned -9% over the past month versus the Zacks S&P 500 composite's +3.4% change. The stock currently has a Zacks Rank #4 (Sell), indicating that it could underperform the broader market in the near term.

Total 2Q 2026 net product revenue of $218.4 million, representing 46% year-over-year growth AUVELITY® 2Q 2026 net product sales of $180.3 million, representing 51% year-over-year growth SUNOSI® 2Q 2026 net product revenue of $35.8 million, representing 20% year-over-year growth SYMBRAVO® 2Q 2026 net product sales of $2.3 million AUVELITY launched for treatment of agitation associated with dementia due to Alzheimer's disease in June 2026 NDA submission for AXS-12 for cataplexy in narcolepsy accepted by the FDA with PDUFA target action date of May 1, 2027 FOCUS-2 and FOCUS-3 Phase 3 trials of solriamfetol in children and adolescents with ADHD initiated Company to host conference call today at 8:00 AM Eastern NEW YORK, Aug. 10, 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 financial results for the second quarter of 2026 and provided a general business update. “The second quarter was highly productive for Axsome.

Wall Street analysts forecast that Axsome Therapeutics (AXSM - Free Report) will report quarterly loss of -$0.99 per share in its upcoming release, pointing to a year-over-year decline of 7.6%. It is anticipated that revenues will amount to $224.52 million, exhibiting an increase of 49.6% compared to the year-ago quarter.

The consensus EPS estimate for the quarter has undergone a downward revision of 14.8% in the past 30 days, bringing it to its present level. This represents how the covering analysts, as a whole, have reassessed their initial estimates during this timeframe.

Before a company reveals its earnings, it is vital to take into account any changes in earnings projections. These revisions play a pivotal role in predicting the possible reactions of investors toward the stock. Multiple empirical studies have consistently shown a strong association between trends in earnings estimates and the short-term price movements of a stock.

While investors typically rely on consensus earnings and revenue estimates to gauge how the business may have fared during the quarter, examining analysts' projections for some of the company's key metrics often helps gain a deeper insight.

Given this perspective, it's time to examine the average forecasts of specific Axsome metrics that are routinely monitored and predicted by Wall Street analysts.

Based on the collective assessment of analysts, 'Revenues- Product sales, net' should arrive at $222.61 million. The estimate suggests a change of +49.4% year over year.

Analysts forecast 'Product Sales, net- Auvelity' to reach $174.71 million. The estimate indicates a year-over-year change of +46.1%.

Analysts expect 'Product Sales, net- Sunosi' to come in at $33.79 million. The estimate suggests a change of +12.6% year over year.

View all Key Company Metrics for Axsome here>>>

Shares of Axsome have demonstrated returns of -15.1% over the past month compared to the Zacks S&P 500 composite's +3.5% change. With a Zacks Rank #4 (Sell), AXSM is expected to lag the overall market performance in the near future. You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here >>>> .

Here are three stocks added to the Zacks Rank #5 (Strong Sell) List today:

Blend Labs (BLND - Free Report) designs and develops software, that offers a platform which focuses on mortgage lending, as well as provides an application experience for home buying process for both buyers and lenders. The Zacks Consensus Estimate for its current year earnings has been revised almost 12.5% downward over the last 60 days.

Axsome Therapeutics (AXSM - Free Report) is a biopharmaceutical company, which is focused on developing novel therapies for the management of central nervous system disorders for which there are limited treatment options available. The Zacks Consensus Estimate for its current year earnings has been revised 7.9% downward over the last 60 days.

Bay Commercial Bank (BCML - Free Report) provides commercial banking products and services to businesses and individuals. The Zacks Consensus Estimate for its current year earnings has been revised almost 6.6% downward over the last 60 days.

View the entire Zacks Rank #5 List.

Posted by Defense World Staff on Jul 27th, 2026

Caxton Associates LLP bought a new stake in Axsome Therapeutics, Inc. (NASDAQ:AXSM – Free Report) during the 1st quarter, according to its most recent filing with the Securities and Exchange Commission. The fund bought 4,311 shares of the company’s stock, valued at approximately $729,000.

Other hedge funds have also made changes to their positions in the company. Kemnay Advisory Services Inc. acquired a new stake in shares of Axsome Therapeutics during the 4th quarter worth approximately $31,000. Hollencrest Capital Management lifted its holdings in Axsome Therapeutics by 400.0% in the first quarter. Hollencrest Capital Management now owns 200 shares of the company’s stock valued at $34,000 after acquiring an additional 160 shares during the last quarter. Ameriflex Group Inc. purchased a new position in Axsome Therapeutics in the fourth quarter worth approximately $37,000. Advisory Services Network LLC purchased a new position in Axsome Therapeutics in the third quarter worth approximately $40,000. Finally, GAMMA Investing LLC grew its position in Axsome Therapeutics by 65.4% in the fourth quarter. GAMMA Investing LLC now owns 268 shares of the company’s stock worth $49,000 after acquiring an additional 106 shares during the period. Hedge funds and other institutional investors own 81.49% of the company’s stock.

Wall Street Analyst Weigh In A number of equities research analysts have commented on the company. Oppenheimer set a $280.00 target price on Axsome Therapeutics in a research report on Monday, May 4th. Robert W. Baird increased their price target on Axsome Therapeutics from $241.00 to $246.00 and gave the stock an “outperform” rating in a report on Tuesday, May 5th. Piper Sandler reiterated an “overweight” rating and set a $258.00 price target on shares of Axsome Therapeutics in a report on Monday, May 4th. BMO Capital Markets assumed coverage on Axsome Therapeutics in a research report on Monday, July 20th. They set an “outperform” rating and a $310.00 price objective for the company. Finally, Royal Bank Of Canada boosted their price objective 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 research analysts have rated the stock with a Strong Buy rating, nineteen have assigned a Buy rating and two have assigned a Sell rating to the company’s stock. According to data from MarketBeat.com, Axsome Therapeutics has a consensus rating of “Moderate Buy” and a consensus price target of $261.48.

Get Our Latest Analysis on Axsome Therapeutics

Insider Activity at Axsome Therapeutics In other news, Director Susan Mahony sold 300 shares of the stock in a transaction dated Tuesday, June 9th. The shares were sold at an average price of $237.21, for a total transaction of $71,163.00. Following the sale, the director owned 1,129 shares of the company’s stock, valued at approximately $267,810.09. This represents a 20.99% 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 the SEC website. The sale was made to cover tax withholding obligations related to the vesting of equity awards. Also, Director Mark Coleman sold 6,000 shares of the stock in a transaction dated Monday, June 1st. The stock was sold at an average price of $230.30, for a total transaction of $1,381,800.00. Following the sale, the director directly owned 35,140 shares in the company, valued at $8,092,742. This represents a 14.58% decrease in their position. The SEC filing for this sale provides additional information. Insiders sold a total of 155,852 shares of company stock worth $37,230,112 over the last ninety days. Company insiders own 20.60% of the company’s stock.

Axsome Therapeutics Price Performance NASDAQ:AXSM opened at $241.00 on Monday. Axsome Therapeutics, Inc. has a 52 week low of $96.09 and a 52 week high of $260.19. The stock’s fifty day moving average is $239.25 and its two-hundred day moving average is $200.80. The stock has a market capitalization of $12.40 billion, a price-to-earnings ratio of -64.61 and a beta of 0.60. The company has a quick ratio of 1.32, a current ratio of 1.39 and a debt-to-equity ratio of 2.27.

Axsome Therapeutics (NASDAQ:AXSM – Get Free Report) last issued its quarterly earnings data on Monday, May 4th. The company reported ($1.26) earnings per share for the quarter, missing analysts’ consensus estimates of ($0.85) by ($0.41). The firm had revenue of $191.20 million during the quarter, compared to analyst estimates of $191.10 million. Axsome Therapeutics had a negative net margin of 26.59% and a negative return on equity of 267.16%. The firm’s revenue was up 57.4% compared to the same quarter last year. Research analysts anticipate that Axsome Therapeutics, Inc. will post -2.45 EPS for the current year.

Axsome Therapeutics Profile (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.

Read More Five stocks we like better than Axsome Therapeutics RTX and Lockheed Earnings: Can Strong Guidance Reset the Defense Trade? These 4 Earnings Reports Expose the Market’s Growing Economic Divide Broadcom May Be the Biggest Winner From Alphabet’s Earnings Volatility Is Back and These 3 Market Tollbooths Are Best Positioned to Profit Want to see what other hedge funds are holding AXSM? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Axsome Therapeutics, Inc. (NASDAQ:AXSM – Free Report).

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Key Takeaways Axsome's NDA for AXS-12 to treat cataplexy in narcolepsy has been accepted for FDA review.Axsome expects the FDA's final decision on the AXS-12 application by May 1, 2027.The FDA does not currently plan to hold an advisory committee meeting to discuss the AXS-12 NDA. Axsome Therapeutics (AXSM - Free Report) announced that the FDA has accepted the company’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.

The regulatory agency has also indicated that it does not plan to hold an advisory committee meeting to discuss the NDA currently.

Axsome recently submitted an NDA to the FDA seeking approval for AXS-12 for the treatment of cataplexy in narcolepsy.

AXSM’s Price PerformanceYear to date, shares of Axsome have rallied 30.1% compared with the industry’s rise of 1.9%.

Image Source: Zacks Investment Research

AXSM Eyes Expansion With Potential Nod to AXS-12A potential nod to AXS-12 should boost Axsome’s narcolepsy franchise.

Axsome completed its acquisition of a commercialized drug targeting narcolepsy, Sunosi (solriamfetol), from Jazz Pharmaceuticals (JAZZ - Free Report) in 2022.

Sunosi’s net product sales were $33.9 million in the first quarter of 2026, up 34% from the year-ago quarter’s level.

The acquisition of Sunosi from Jazz diversified Axsome’s commercial portfolio. The drug has become an important revenue driver for Axsome.

However, competition in the target market is growing, which remains a concern.

Alkermes (ALKS - Free Report) is developing alixorexton, a novel, investigational, oral, selective orexin 2 receptor agonist, in late-stage studies for the treatment of narcolepsy type 1 and narcolepsy type 2.

ALKS is also developing alixorexton in mid-stage studies for treating idiopathic hypersomnia. The successful development and potential approval of alixorexton is likely to induce acute competition for Axsome’s Sunosi as well as AXS-12.

Jazz’s other sleep disorder drugs, Xyrem and Xywav, also have a strong foothold in the target market.

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

A better-ranked stock in the biotech sector is Liquidia Corporation (LQDA - Free Report) , 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 Liquidia’s 2026 earnings per share have risen from $2.97 to $3.02, while estimates for 2027 have increased from $4.81 to $4.92 during the same time. LQDA shares have surged 125.4% 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%.

July 14, 2026 07:00 ET  | Source: Axsome Therapeutics, Inc.

NEW YORK, July 14, 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 it will report its financial results for the second quarter of 2026 on Monday, August 10, 2026, before the opening of the U.S. financial markets. Axsome management will then host a conference call at 8:00 a.m. Eastern Time to discuss these results and provide a business update.

To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic) or +1 (201) 389-0851 (international). A live webcast of the conference call can be accessed on the “Webcasts & Presentations” page of the “Investors” section of the Company’s website at www.axsome.com. A replay of the conference call will be available on the Company’s website for approximately 30 days following the live 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, and multiple early- to 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]

Key Takeaways Axsome dosed the first patient in the phase III FOCUS-2 study of solriamfetol for children with ADHD.The placebo-controlled study will evaluate solriamfetol's safety and efficacy in children with ADHD.Axsome is also running separate phase III ADHD studies in adolescents and adults for solriamfetol. Axsome Therapeutics (AXSM - Free Report) announced that it has dosed the first patient in the phase III FOCUS-2 study evaluating solriamfetol for the treatment of attention deficit hyperactivity disorder (ADHD) in children aged six to less than 12 years.

The randomized, double-blind, placebo-controlled phase III FOCUS-2 study is designed to assess the safety and efficacy of solriamfetol in children aged six to less than 12 years with ADHD. The primary endpoint of the study is to see the change from baseline to week six in the ADHD Rating Scale (ADHD-RS-5) total score.

Last month, the company initiated the phase III FOCUS-3 study evaluating solriamfetol for treating ADHD in adolescents aged 12 to less than 18 years.

Axsome is also conducting the phase III FOCUS study, which is evaluating solriamfetol for treating ADHD in adults.

AXSM’s Price PerformanceYear to date, shares of Axsome have rallied 36.8% compared with the industry’s increase of 6.8%.

Image Source: Zacks Investment Research

Axsome currently markets solriamfetol as Sunosi for treating narcolepsy.

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

AXSM's Other Ongoing Studies on SolriamfetolBesides ADHD, Axsome is evaluating solriamfetol in separate phase III studies for treating major depressive disorder (MDD), binge eating disorder (BED) and excessive sleepiness associated with shift work disorder (SWD).

In February 2026, Axsome initiated the phase III CLARITY study evaluating solriamfetol for the treatment of MDD with excessive daytime sleepiness symptoms. The primary endpoint of the study will be to check the time from randomization to relapse of depressive symptoms.

The phase III ENGAGE study is evaluating solriamfetol in BED, with top-line data from the same expected in the second half of 2026. The phase III SUSTAIN study is evaluating solriamfetol in SWD in adults, with top-line data expected to be announced in 2027.

Sunosi has become an important revenue driver for Axsome since its acquisition from Jazz. The drug generated sales worth $33.9 million in the first quarter of 2026, reflecting an increase of 34% on a year-over-year basis.

Successful development and potential approval for Sunosi in additional indications are likely to boost sales further in future quarters.

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

Some better-ranked stocks in the biotech sector are Kiniksa Pharmaceuticals (KNSA - 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 Kiniksa Pharmaceuticals’ 2026 earnings per share have risen from $1.24 to $1.25, while estimates for 2027 have increased from $1.70 to $1.76 during the same time. KNSA shares have soared 63.1% year to date.

Kiniksa Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 1.53%.

Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $3.02, while estimates for 2027 have increased from $2.91 to $4.92 during the same time. LQDA shares have surged 135.5% 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 (AXSM 1.68%) has been going through a particularly significant growth phase in recent years, launching drugs for central nervous system (CNS) conditions and pushing several candidates through late-stage clinical trials. Investors have recognized the company's potential and piled into the stock -- it's climbed more than 220% over the past three years.

And considering these product launches are pretty recent, and any pipeline success could produce new revenue drivers, it's fair to say this biopharma company is in the early days of its growth story. Considering this, is Axsome stock a millionaire maker? Let's take a look at what the numbers say.

Image source: Getty Images.

Three approved drugs First, though, let's take a close look at Axsome's story as a commercial-stage company. Axsome specializes in the treatment of CNS disorders, a market that spans Alzheimer's disease, major depressive disorder, narcolepsy, fibromyalgia, and other conditions. So Axsome's capabilities open the door to many markets that could support growth over time. The company sells Auvelity for agitation linked to Alzheimer's disease, and the drug is also approved for depression. Axsome's other products are Sunosi for daytime sleepiness associated with sleep apnea or narcolepsy, and Symbravo for migraine relief.

The two most recent approvals include the Alzheimer's indication for Auvelity in April of this year and the approval of Symbravo in January of last year. So the company is in the early stages of growth in those areas -- and the potential of Axsome's drugs was evident in the latest earnings report.

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Double-digit product revenue growth Auvelity product revenue soared 59% in the quarter to $153 million, and Sunosi revenue climbed 34% to $33 million. Symbravo only launched early last year, so it doesn't have a year-over-year comparison figure -- but the company offered clues that give investors reason to be optimistic about the drug's potential. Doctors wrote about 17,000 prescriptions for the migraine drug in the first quarter, and based on the drug's growth, Axsome is increasing its Symbravo sales force.

It's also important to note that the company may still progress on payer coverage for Symbravo, which should trigger additional growth. Right now, coverage is at 57% compared to more than 80% for the company's other drugs.

Another potentially big growth driver for Axsome is the Alzheimer's indication. Auvelity was just made available to these patients in June, with a sales force of more than 600 to bring the treatment to the attention of doctors, from primary care physicians to neurologists and geriatric specialists.

Another potential launch on the horizon Meanwhile, Axsome has submitted AXS-12 for narcolepsy to regulators for review, so another product launch may be on the horizon. And the company has solriamfetol in phase three trials for four indications: attention deficit hyperactivity disorder, major depressive disorder, binge eating disorder, and shift work disorder. Finally, AXS-14 for fibromyalgia is also in a phase 3 trial. So the company's late-stage pipeline is almost bursting at the seams, which could lead to explosive growth in the coming years if all goes smoothly.

It's clear that Axsome is a young biopharmaceutical company that's on the rise, due to recently launched drugs and candidates that are nearing the finish line. Now let's get back to our question: Could this stock make you a millionaire?

Axsome stock has climbed quite a bit in recent times, but it still could have plenty of room to run as the era of revenue growth unfolds. The company has $305 million in cash and says this position will help it fund operations "into cash flow positivity." So we really are at the start of the Axsome story.

Still, a look at the numbers shows us just how difficult it is to reach $1 million by investing in one stock. For example, if you invested $1,000 in Axsome stock and it climbed 500%, you would have $6,000. That would leave Axsome stock trading at more than $1,400 -- and at a trillion-dollar market value. That's very unlikely.

But this doesn't mean you should avoid Axsome stock. The best way to reach $1 million through investing is to buy shares of many quality companies -- and Axsome would make an excellent part of the group -- and hold on for the long term.

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

NEW YORK, June 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 that the first patient has been dosed in the FOCUS-3 Phase 3 trial evaluating solriamfetol as a treatment for adolescents with attention deficit hyperactivity disorder (ADHD).

FOCUS-3 (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 adolescents aged 12 to less than 18 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.

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.