Přípravek Auvelity společnosti Axsome dosáhl v první polovině roku 2026 tržeb ve výši 333 milionů USD, což představuje meziroční nárůst o 54,2 %, tažený léčbou velké deprese.
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.
Tržby přípravku Auvelity od společnosti Axsome Therapeutics dosáhly ve 2. čtvrtletí 180,3 milionu USD, což představuje meziroční nárůst o 51 %, po dubnovém schválení FDA pro léčbu neklidu spojeného s demencí v důsledku Alzheimerovy choroby a červnovém uvedení pro tuto indikaci.
Axsome Therapeutics (AXSM -0.47%) entered 2026 with Auvelity already generating more than half a billion dollars in annual sales for major depressive disorder. Now the drug is expanding into a second potentially massive market: agitation associated with Alzheimer's disease.
In April, the FDA approved Auvelity for agitation associated with dementia due to Alzheimer's disease, making it the first approved treatment for the condition that isn't an antipsychotic. Axsome launched it for the new indication in June. And the early numbers look good.
Auvelity generated $180.3 million in second-quarter sales, up 51% year over year. During the first eight weeks following the Alzheimer's launch, new patient starts among people 65 and older jumped 126% compared with the same period in the previous quarter.
Auvelity is becoming a much bigger drug
Auvelity was originally approved in 2022 for major depressive disorder. By 2025, sales reached $507.1 million. Now, Alzheimer's agitation treatment dramatically expands that opportunity.
Image source: Getty Images.
To clarify, agitation can include excessive movement, restlessness, verbal aggression, and physical aggression. It's also one of the most difficult symptoms for caregivers to manage.
Axsome now believes Auvelity can eventually generate at least $8 billion in annual peak sales, with roughly half coming from depression and half from Alzheimer's agitation. To be clear, that's a company estimate rather than a forecast, and management hasn't said when it expects Auvelity to reach that level. Still, the trajectory is hard to ignore.
The drugmaker expanded the Auvelity sales force from roughly 300 representatives to more than 600 to reach psychiatrists, neurologists, geriatric specialists, and primary-care doctors. Insurance coverage has also reached approximately 89% of covered lives. . If the Alzheimer's launch continues to gain traction, Auvelity could potentially generate several billion dollars annually by the end of the decade.
This isn't just about Auvelity
Axsome already has two other commercial products. There's Sunosi, which is used to treat excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. That generated $35.8 million in Q2 revenue. Then there's Symbravo, Axsome's migraine treatment. This one is much newer and only generated $2.3 million in Q2 sales, but underlying demand is growing quickly, with prescriptions rising 30% from the previous quarter to approximately 23,500 in Q2. Axsome believes the drug could eventually generate $500 million to $1 billion in annual peak sales.
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There's also the pipeline, which includes AXS-12 and AXS-14. AXS-12 is being developed for narcolepsy, with an FDA decision currently scheduled for May 1, 2027. AXS-14 is being developed for fibromyalgia and has already produced positive Phase 3 results. Axsome is also studying solriamfetol, a "wakefulness-promoting" medication in additional conditions, including ADHD, depression, and binge eating disorder.
Overall, management believes its pipeline could support an average of one new FDA drug application filing per year through 2030. Of course, not all of those programs will necessarily succeed. But Axsome no longer needs every pipeline candidate to work, for the company to grow substantially.
What could Axsome look like in 2030?
The biggest risk is execution. Axsome is spending aggressively to commercialize its drugs. Selling, general, and administrative expenses totaled $208.1 million in Q2, yet the company posted a $51.3 million net loss despite generating $218.4 million in product revenue.
That spending makes sense if Auvelity continues scaling rapidly. It becomes more problematic if the Alzheimer's launch disappoints. But if it plays out as management expects, Axsome could have a multibillion-dollar flagship drug supported by several additional commercial products by 2030.
Now, Auvelity doesn't need to reach $8 billion by 2030 for that scenario to work. If depression treatment sales keep climbing, Alzheimer's agitation becomes another major market, and even a few pipeline programs reach commercialization, Axsome could graduate from a successful biotech to a sizable neuroscience pharmaceutical company.
Axsome Therapeutics uvedla, že předepisování AUVELITY zrychluje po rozšíření prodejního týmu a novém spuštění na agitaci u Alzheimerovy choroby. Firma očekává, že tento segment bude nejrychleji rostoucí.
Biotech Is Heating Up—These 2 Red-Hot Stocks Stand OutAxsome Therapeutics NASDAQ: AXSM executives said the company is seeing accelerating prescription growth for AUVELITY following its sales-force expansion and the recent launch of the drug in Alzheimer’s disease agitation, while management expects operating expenses to remain relatively stable in the second half of the year.
Speaking at Morgan Stanley’s Global Healthcare Conference, Chief Financial Officer Nick Pizzie said the majority of AUVELITY prescription growth in the second quarter was tied to major depressive disorder and the expanded commercial organization. More recently, however, the Alzheimer’s disease agitation indication has begun to contribute more meaningfully to new-to-brand prescription trends.
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5 medical stocks growing earnings by triple digits“The agitation indication is the fastest-growing segment within the NBRXs,” Pizzie said, referring to new-to-brand prescriptions. He said patients aged 65 and older represented about 19% of AUVELITY new-to-brand prescriptions in the four weeks preceding approval for the new indication, compared with roughly 31% more recently.
Pizzie said AUVELITY reached a record 3,800 weekly new-to-brand prescriptions on the Friday before the conference. Average weekly new-to-brand prescriptions were about 2,400 in the first quarter and 3,000 in the second quarter, he said. The company had also recorded three consecutive weeks of its highest new-to-brand prescription levels.
AUVELITY Launch Metrics and Sampling Struggling Axsome Stock Could Bounce Back on Drug Trial SuccessChief Operating Officer Mark Jacobson said Axsome expects the commercial effects of both its expanded field force and Alzheimer’s disease agitation launch to emerge over one to two quarters, rather than produce an immediate jump in overall prescription data.
He said the company is focused on new-to-brand prescriptions and new prescribers as earlier indicators of adoption, which it expects eventually to translate into total prescription growth. Jacobson added that physician feedback on AUVELITY in Alzheimer’s disease agitation has been encouraging, with prescribers reporting that the product is working well and demonstrating a favorable tolerability profile.
The company is using a sampling program that includes a three-week titration pack for Alzheimer’s disease agitation. Jacobson said sample conversion rates can fluctuate during the early launch period, including because some patients transitioning from other therapies may be titrated more slowly or receive maintenance-dose samples.
Axsome has not disclosed sample conversion rates and does not plan extensive commentary on its sampling strategy, Jacobson said. Still, he said the company is seeing samples convert into prescriptions and expects its third-quarter results to provide a more complete view of the launch. Pizzie said Axsome is considering providing investors with additional launch metrics when it reports its first full quarter of results for the new indication.
Commercial Opportunity and Market Access Management reiterated its long-term $8 billion peak-sales model for AUVELITY, including $4 billion each in major depressive disorder and Alzheimer’s disease agitation. Pizzie characterized the assumptions underlying that outlook as conservative.
In major depressive disorder, AUVELITY had captured approximately 26 basis points of the overall antidepressant market as of the end of the second quarter, according to Pizzie. He said that level of market share corresponded with a run rate approaching three-quarters of a billion dollars, while 1% of the total market would represent more than $3 billion in sales.
For Alzheimer’s disease agitation, Pizzie cited more than 20 million prescriptions and said that roughly 99% of the market had previously consisted of generic, off-label treatments. Jacobson said the company’s model uses lower persistence assumptions for Alzheimer’s disease agitation than it uses in depression, despite clinical results showing durable responses and low discontinuation rates.
Axsome has more than doubled its commercial team and added a long-term-care team, Pizzie said. The company has 89% coverage of total covered lives, including 100% Medicare coverage, and has first-line or first-switch positioning in a majority of covered plans, he added. The expanded organization is intended to deepen coverage among high-decile prescribers while expanding outreach to primary care providers.
Pipeline, Spending and Cash Flow Jacobson highlighted several development programs for solriamfetol, with attention focused on attention-deficit/hyperactivity disorder, major depressive disorder with excessive sleepiness, binge eating disorder and shift work disorder. Two pediatric ADHD studies are underway, and positive results from both could support a filing, he said. A completed adult ADHD study was positive, according to Jacobson.
The company expects a fourth-quarter readout from the ENGAGE trial in binge eating disorder. Jacobson said Axsome would likely need an additional study for a filing if ENGAGE is positive. For shift work disorder, he said the company expects that one positive study could support an application because of the condition’s relationship to solriamfetol’s existing approved uses.
For AXS-12 in cataplexy and narcolepsy, Jacobson said Axsome sees a $500 million to $1 billion commercial opportunity. He cited daytime dosing, a distinct safety and tolerability profile, and clinical benefits in cataplexy, sleep, excessive daytime sleepiness and cognition as potential differentiators. Pizzie said the PDUFA date is May 1, 2027.
Pizzie said selling, general and administrative expense of $208 million in the second quarter should be a reasonable reference point for the back half of the year, as the cost of the sales-force expansion was largely included in that figure. Research and development expense, which was $46 million in the second quarter, is expected to rise modestly as the company runs five Phase 3 trials.
Management said revenue is expected to grow faster than operating expenses, creating operating leverage. Pizzie declined to specify the quarter in which Axsome expects to reach cash-flow positivity, but said the company has a “very clear path” toward positive cash flow and profitability thereafter.
Jacobson also said Axsome plans to continue investing in commercial execution and pipeline development, including label-expansion efforts for marketed products. The company recently began the Phase 3 SUMMIT trial of AUVELITY in smoking cessation and is evaluating other potential indications across its portfolio.
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.
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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Axsome Therapeutics uvedla, že výnosy ve 2. čtvrtletí vzrostly na 218,4 milionu USD, hlavně díky přípravku Auvelity. Firma zároveň rozšířila prodejní síť na zhruba 630 lidí.
Biotech Is Heating Up—These 2 Red-Hot Stocks Stand OutAxsome 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.
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5 medical stocks growing earnings by triple digitsChief 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.
Struggling Axsome Stock Could Bounce Back on Drug Trial SuccessPizzie 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.
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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Axsome Therapeutics má podle průměrného cílového kurzu 285,42 USD potenciál růstu o 35 % během příštích 12 měsíců. Ve 2. čtvrtletí tržby vzrostly meziročně o 46 % na 218,4 milionu USD.
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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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 uvedla, že její hotovost má financovat provoz až do dosažení kladného cash flow. Akcie přitom za poslední tři měsíce klesly asi o 15 %.
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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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.
NEW YORK, Aug. 31, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that the first patient has been dosed in the SUMMIT Phase 3 trial of AXS-05 for smoking cessation.
SUMMIT (Studying NMDA and Sigma-1 in Smoking Cessation Treatment) is a Phase 3 randomized, double-blind, active- and placebo-controlled, multicenter trial to assess the efficacy and safety of AXS-05 as a smoking cessation treatment in adults. Active smokers will be randomized in a 1:1:1 ratio to receive AXS-05, bupropion, or placebo for approximately 12 weeks. The primary endpoint will be smoking abstinence at the end of the 12-week treatment period.
About Smoking Cessation
Approximately 34 million adults in the U.S. smoke cigarettes and more than half of those live with a smoking-related disease.1 Smoking is the single largest cause of preventable disease in the U.S., accounting for 1 in 5 deaths.2 The overall cost of smoking exceeds $300 billion annually in the U.S. making it a significant health-economic need.1 Nearly 70% of adult smokers say they want to quit but only 3-5% who attempt to quit without assistance are successful for 6-12 months.1,3
About AXS-05
AXS-05 (dextromethorphan-bupropion) is a novel, oral, investigational N-methyl-D-aspartate (NMDA) receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor under development for smoking cessation. AXS-05 is covered by a robust patent estate extending out to at least 2043. AXS-05 (AUVELITY®) is approved in the U.S. for the treatment of major depressive disorder in adults and agitation associated with dementia due to Alzheimer’s disease. AXS-05 is not approved by the FDA as a smoking cessation treatment.
About Axsome Therapeutics
Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.
Forward Looking Statements
Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company’s ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.
U.S. Department of Health and Human Services. (2020). Smoking Cessation: A Report of the Surgeon General.U.S. Centers for Disease Control and Prevention. (2020). Tobacco-Related MortalityHughes, J.R. et al. Shape of the relapse curve and long-term abstinence among untreated smokers. Addiction. 2003. (99):29-38.
Axsome Therapeutics ve 2. čtvrtletí zvýšila tržby o 46 % na 218,4 milionu USD, hlavně díky přípravku Auvelity. Wall Street vidí průměrný cenový cíl 285,42 USD, tedy asi 37% růst.
Axsome Therapeutics (AXSM -0.13%), a biotech company, has performed fairly well this year. The company's shares are up 16% versus the S&P 500's 11%. Could the stock rise even higher? Wall Street certainly thinks so. Axsome Therapeutics' average price target (according to Yahoo! Finance) of $285.42 implies about a 37% upside from its current level. Let's find out why Wall Street is bullish on the stock and whether it's time to buy it.
Image source: The Motley Fool.
Axsome Therapeutics' recent financial results Axsome Therapeutics has made significant clinical and regulatory progress over the past few years. The company earned approval for Auvelity as a treatment for depression, and more recently won a label expansion for the medicine in treating Alzheimer's disease (AD) agitation. Axsome Therapeutics' approved portfolio also includes Symbravo, a migraine therapy, and Sunosi, which treats daytime sleepiness due to narcolepsy. Axsome Therapeutics' sales are growing rapidly. In the second quarter, the company's revenue increased by 46% year over year to $218.4 million. Auvelity is the main growth driver.
It contributed $180.3 million in net product sales, up 51% compared to the year-ago period. The good news is that Auvelity's indication in AD agitation is still brand-new. The U.S. Food and Drug Administration granted it in April. So, as the medicine gains significant traction in this market, it will help boost its sales. And there is a large addressable opportunity here. AD agitation affects more than five million patients in the U.S., and treatment options are limited.
So, Auvelity could fill an unmet need. Eventually, it could also earn another label expansion in smoking cessation, since Axsome is gearing up to start a phase 2/3 study in that indication. Axsome Therapeutics' Sunosi could also receive label expansions. It is currently being investigated in phase 3 studies as a potential treatment for depression, ADHD, and binge eating disorder. If it can land these additional approvals, it would become more successful and help improve Axsome Therapeutics' financial results.
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Why the future looks bright Axsome Therapeutics' pipeline doesn't end with Auvelity and Sunosi. In fact, the company boasts a rich lineup of mid and late-stage candidates that could transform its approved portfolio over the next few years. Here are some of these products. One of them is AXS-12, an investigational medicine for cataplexy in narcolepsy. This candidate has already cleared phase 3 studies and is currently under review by U.S. regulators.
Axsome Therapeutics estimates peak sales for AXS-12 between $500 million and $1 billion in narcolepsy. Then there is AXS-14, an investigational therapy for fibromyalgia. It is currently undergoing late-stage studies, as is the biotech's AXS-20, which is being developed to treat schizophrenia. Between these and other products in development, Axsome Therapeutics estimates that it could generate peak sales above $16 billion.
The company won't get there in a year or two. But considering its current market cap of roughly $11 billion, Axsome Therapeutics may be an attractive stock to buy even if it can land $16 billion in annual revenue by 2040. Here is why. Assuming a price-to-sales ratio of 3 by 2040 -- which is a reasonable assumption in the biotech industry -- if Axsome Therapeutics generates $16 billion in revenue by then, the company's market cap will be $48 billion. From its current level of $11 billion, it would grow at a compound annual rate of 11.1% over the next 14 years, which is a pretty strong return.
Of course, there are risks. Axsome Therapeutics could fail to launch one or more of its current pipeline projects due to clinical or regulatory setbacks. It could also face stronger competition in markets where it currently performs well, such as depression treatments, where several pharmaceutical giants dominate. However, the $16 billion projection only takes into account the company's more advanced programs, not several earlier projects that may also contribute to the top-line down the road.
So, even with the risk of clinical setbacks, Axsome Therapeutics has a large enough pipeline to generate competitive returns over the long run. Wall Street is right to be bullish, and investors should seriously consider buying this healthcare stock.
Axsome Therapeutics ve 2. čtvrtletí 2026 zvýšila čisté tržby z produktů na 218,4 milionu USD, meziročně o 46 %. AUVELITY přidal 51 % na 180,3 milionu USD.
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 >>>> .
Axsome Therapeutics oznámila, že FDA přijala k posouzení její NDA pro AXS-12 na léčbu kataplexie u narkolepsie. Úřad stanovil cílové datum rozhodnutí na 1. května 2027.
July 15, 2026 07:00 ET | Source: Axsome Therapeutics, Inc.
FDA sets PDUFA target action date of May 1, 2027
NEW YORK, July 15, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s New Drug Application (NDA) for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027. The FDA also indicated that it does not currently plan to hold an advisory committee meeting to discuss the application.
About Narcolepsy
Narcolepsy is a serious and debilitating orphan neurological condition that causes dysregulation of the sleep-wake cycle and is characterized clinically by excessive daytime sleepiness, cataplexy, hypnagogic hallucinations, sleep paralysis, and disrupted nocturnal sleep.1-3 Cataplexy is seen in an estimated 70% of narcolepsy patients and is a sudden reduction or loss of muscle tone while a patient is awake, typically triggered by strong emotions such as laughter, fear, anger, stress, or excitement.4-5 Narcolepsy is a life-long condition that interferes with cognitive, psychological, and social functioning, increases the risk of work- and driving-related accidents, and is associated with a 1.5-fold higher mortality rate.6-8
About AXS-12
AXS-12 (reboxetine) is a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator under development for the treatment of narcolepsy. AXS-12 is thought to modulate noradrenergic activity to maintain muscle tone during wakefulness, and noradrenergic and cortical dopaminergic signaling to promote wakefulness and cognition function. AXS-12 has been granted U.S. Food and Drug Administration (FDA) Orphan Drug Designation for the treatment of narcolepsy. AXS-12 is not approved by the FDA.
About Axsome Therapeutics
Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.
Forward Looking Statements
Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company’s ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.
American Academy of Sleep Medicine. The International Classification of Sleep Disorders. Third Edition (ICSD-3). 2014.National Institute of Neurological Disorders and Stroke. Narcolepsy. https://www.ninds.nih.gov/health-information/disorders/narcolepsy. Accessed September 2024.España RA, Scammell TE. Sleep neurobiology from a clinical perspective. Sleep. 2011 Jul 1;34(7):845-58.Narcolepsy Network. About Narcolepsy. https://narcolepsynetwork.org/about-narcolepsy/. Accessed September 2024.Swick TJ. Treatment paradigms for cataplexy in narcolepsy: past, present, and future. Nat Sci Sleep. 2015 Dec 11;7:159-69.Tadrous R, O'Rourke D, Mockler D, Broderick J. Health-related quality of life in narcolepsy: A systematic review and meta-analysis. J Sleep Res. 2021 Dec;30(6):e13383.Patil SP, Ayappa IA, Caples SM, Kimoff RJ, Patel SR, Harrod CG. Treatment of Adult Obstructive Sleep Apnea With Positive Airway Pressure: An American Academy of Sleep Medicine Systematic Review, Meta-Analysis, and GRADE Assessment. J Clin Sleep Med. 2019 Feb 15;15(2):301-334.Ohayon MM, Black J, Lai C, Eller M, Guinta D, Bhattacharyya A. Increased mortality in narcolepsy. Sleep. 2014 Mar 1;37(3):439-44.
Axsome Therapeutics zahájila klinickou studii fáze 3 FOCUS-2 se solriamfetolem u dětí ve věku 6 až méně než 12 let s ADHD. První pacient už dostal dávku.
July 07, 2026 07:00 ET | Source: Axsome Therapeutics, Inc.
The FOCUS-2 trial in children complements the recently announced FOCUS-3 trial in adolescents with ADHD
NEW YORK, July 07, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that the first patient has been dosed in the FOCUS-2 Phase 3 trial evaluating solriamfetol as a treatment for children with attention deficit hyperactivity disorder (ADHD).
FOCUS-2 (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol in children aged 6 to less than 12 years with ADHD. Approximately 468 patients will be randomized in a 1:1:1 ratio to receive one of two doses of solriamfetol or placebo for 6 weeks. The primary endpoint will be the change from baseline to week 6 in the ADHD Rating Scale (ADHD-RS-5) total score.
Previously, Axsome announced the initiation of the FOCUS-3 Phase 3 trial of solriamfetol in adolescents aged 12 to less than 18 years with ADHD.
About Attention Deficit Hyperactivity Disorder (ADHD)
Attention deficit hyperactivity disorder (ADHD) is a chronic neurobiological and developmental disorder characterized by a persistent pattern of inattention, hyperactivity, or impulsivity, that interferes with functioning or development.1 Impairments in cognition are apparent in attention, planning and problem solving, working memory, and behavioral inhibition.2,3 An estimated 15.5 million adults and 7 million children in the U.S. are affected by ADHD,4,5 with approximately two-thirds or more of children with ADHD continuing to experience symptoms into adulthood.6 The total annual societal excess cost associated with adult ADHD in the U.S. has been estimated at over $120 billion.7
About Solriamfetol
Solriamfetol is a dopamine and norepinephrine reuptake inhibitor (DNRI), TAAR1 agonist, and 5-HT1A agonist being developed for the treatment of attention deficit hyperactivity disorder (ADHD), major depressive disorder (MDD) with excessive daytime sleepiness (EDS), binge eating disorder (BED), and excessive sleepiness associated with shift work disorder (SWD).
About Axsome Therapeutics
Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.
Forward Looking Statements
Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company’s ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.
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.
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.
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