Axsome Therapeutics Inc

B. Riley analyst Mayank Mamtani has identified six top biotech picks heading into third-quarter 2026 earnings season, following the Federal Reserve's 25 basis point rate hike to 4.00%, its first increase since July 2023. The unanimous 12-0 vote left room for one to two additional hikes before year-end, and with the 10-year Treasury at its highest level since 2007, small and mid-cap biotech stocks face a macro-driven drawdown that historically has presented buying opportunities. The XBI index is up 27% year-to-date but down 2% quarter-to-date, compared to the S&P 500's 13% and 4% gains respectively, while loss of exclusivity-driven pharma mergers and acquisitions track toward their strongest year since 2019, permanent FDA leadership is installed, and drug-pricing risk is largely resolved through most favored nation agreements covering 26 companies. Late third quarter and fourth quarter carry over 40 company-specific catalysts across the coverage list. The picks are Axsome Therapeutics, rated Buy with a $300 price target and up 6% year-to-date, where the analyst models AUVELITY revenue at approximately $205 million to $210 million against consensus of $215.8 million and total revenue of approximately $259 million; Cytokinetics, rated Buy with a $146 price target and up 4% year-to-date, with MYQORZO wholesale tracking to approximately $18 million for the full third quarter versus $8.9 million for all of second quarter; Eton Pharmaceuticals, rated Buy with a $70 price target and up 229% year-to-date, with consensus third-quarter 2026 and fiscal year 2026 revenue of $42 million and $149.7 million versus management's guidance of over $145 million for fiscal year 2026; Harrow, rated Buy with a $60 price target and down 31% year-to-date, with fiscal year 2026 guidance of $350 million to $365 million; TG Therapeutics, rated Buy with an $86 price target and up 95% year-to-date, positioned to compound off an approximately $1 billion U.S. Briumvi exit run-rate at year-end 2026; and Zymeworks, rated Buy with a $44 price target and up 4% year-to-date, where partner Jazz Pharmaceuticals' third-quarter 2026 report in early November provides the first commercial read on the first-line HER2-positive gastroesophageal adenocarcinoma launch following the August 25 approval and $250 million milestone.

Axsome Therapeutics said AUVELITY prescriptions are accelerating after its sales-force expansion and the drug's launch in Alzheimer's disease agitation, with weekly new-to-brand prescriptions reaching a record 3,800. Speaking at Morgan Stanley's Global Healthcare Conference, Chief Financial Officer Nick Pizzie said patients aged 65 and older now account for about 31% of new-to-brand prescriptions, up from roughly 19% before the indication's approval, and that agitation is the fastest-growing segment. Average weekly new-to-brand prescriptions were about 2,400 in the first quarter and 3,000 in the second quarter. Management reiterated its $8 billion long-term peak-sales outlook for AUVELITY, split evenly between $4 billion in major depressive disorder and $4 billion in Alzheimer's disease agitation, and reported 89% coverage of total covered lives, including 100% Medicare coverage. Pizzie said second-quarter selling, general and administrative expense of $208 million should be a reasonable reference point for the back half of the year, while research and development expense of $46 million is expected to rise modestly, and management expects revenue to grow faster than operating expenses on a very clear path toward positive cash flow and profitability.

Axsome Therapeutics reported new clinical data in major depressive disorder and Alzheimer's disease agitation at a leading psychiatry congress. The presentations focused on key programs in Axsome's central nervous system pipeline aimed at treating mood and neuropsychiatric symptoms, and management highlighted how the new findings may inform future study designs and regulatory interactions for these indications. The company is advancing multiple late-stage clinical programs, including AXS-05, AXS-12, AXS-14, and several solriamfetol indications, and the fresh congress results give more clinical detail around AXS-05 in depression and Alzheimer's agitation, feeding the thesis that future CNS indications can broaden the revenue mix beyond Auvelity, Sunosi and SYMBRAVO. Axsome, a mid-sized US pharmaceuticals player with a market cap of $11.2b, competes alongside larger CNS-focused drug developers such as Biogen and Eli Lilly and smaller specialists. The same update also stress tests a key risk: management must commercialise several CNS assets at once while running high R&D and SG&A spending, with payer scrutiny and strong rivals in both categories.

Axsome Therapeutics shares rose about 6% in Friday trading after data showed prescriptions for Auvelity reached a record high. Data from Symphony Health, part of HealthVerity, found that scripts for the depression and Alzheimer's disease agitation treatment hit roughly 23,500 this week. The US FDA granted the Alzheimer's agitation indication in late April. Mizuho analyst Graig Suvannavejh, who rates Axsome at outperform, said that while it is still early days in the launch, this appears highly indicative of a strong start for Auvelity in ADA.

Axsome Therapeutics has dosed the first patient in the phase III SUMMIT study evaluating AXS-05 for smoking cessation. The randomized, double-blind, placebo-controlled trial will assess the safety and efficacy of AXS-05 in adult smokers, with participants receiving AXS-05, bupropion, or placebo in a 1:1:1 ratio for about 12 weeks, and the primary endpoint is smoking abstinence at the end of treatment. AXS-05, marketed as Auvelity in the U.S. for major depressive disorder, was approved in April 2026 for agitation associated with Alzheimer's dementia. Auvelity generated $333 million in first-half 2026 sales, up 54.2% year over year, while Sunosi contributed $66.5 million, up 25.5%, and Symbravo added $6.3 million. Year to date, Axsome shares have risen 8.7% versus the industry's 9.7%.

Axsome Therapeutics signaled a pipeline cadence of roughly one new drug application filing per year through 2030, with its AXS-12 for cataplexy in narcolepsy receiving a PDUFA target action date of May 1, 2027. The company reported second-quarter 2026 net product revenue of $218 million, a 46% increase from the prior year, driven by AUVELITY and SUNOSI. AUVELITY net product sales reached $180.3 million, SUNOSI net product revenue was $35.8 million, and SYMBRAVO net sales were $2.3 million, though SYMBRAVO faced gross-to-net discount pressure that pushed the metric into the high 80% range due to a prior-period adjustment and patient service utilization. Management expects SYMBRAVO gross-to-net to normalize for the remainder of the year and reiterated that its current cash balance of approximately $320 million is sufficient to fund operations into cash flow positivity. Early launch metrics for AUVELITY in Alzheimer’s disease agitation showed a 126% increase in new-to-brand prescriptions among patients 65 and older during the first eight weeks compared to the same period in the prior quarter.

The Alzheimer's disease market across the seven major markets was valued at approximately USD 4 billion in 2025 and is projected to expand at a CAGR of 22.7% through 2036, according to DelveInsight. The growth is driven by increasing disease prevalence, broader adoption of disease-modifying therapies, advancements in biomarker-based diagnosis, and a robust late-stage pipeline. Key emerging therapies include Masupirdine from Suven Life Sciences, Roche's Trontinemab, Annovis Bio's Buntanetap, AB Science's Masitinib, Eli Lilly's Remternetug, Axsome Therapeutics' AUVELITY, Biovie's Bezisterim, ALZHEON's Valiltramiprosate, TauRx Therapeutics' Hydromethylthionine mesylate, Bristol Myers Squibb's COBENFY, AriBio's AR1001, Acadia Pharmaceuticals' Remlifanserin, and Cerecin's Tricaprilin. The report highlights six late-stage candidates poised to enter the market, including Masupirdine, Trontinemab, AXS-05, COBENFY, Remternetug, and Buntanetap, each with distinct mechanisms of action and anticipated clinical milestones.

Jazz Pharmaceuticals is refocusing its sleep-disorder franchise after Axsome Therapeutics disclosed an FDA filing for AXS-12 in narcolepsy, highlighting Sunosi's move from Jazz's portfolio. Jazz shares have returned 119.3% over the past year and 42.3% over five years, with a 9.1% gain in the last month. The stock closed at $247.53, about 6% below the average analyst target, while Simply Wall St estimates a fair value of $257.00, suggesting the stock is slightly undervalued. Expected approvals for dordaviprone in H3 K27M-mutant diffuse glioma and Zepzelca in first-line small cell lung cancer maintenance are seen as key growth drivers, though risks include patent expirations and reliance on a few pipeline launches.

Axsome Therapeutics is the better growth buy over Revolution Medicines right now, according to a Motley Fool analysis. Axsome already has three commercialized products—Auvelity, Sunosi, and Symbravo—and recently won two new approvals, driving double-digit revenue gains. Its late-stage pipeline includes five phase 3 programs and a regulatory submission for AXS-12 in narcolepsy. Revolution Medicines, while promising, is earlier-stage with no marketed products, and its stock has surged 135% in the first half, suggesting better buying opportunities may come on a dip. Axsome’s nearer-term growth prospects and room for further stock appreciation make it the preferred choice.

Axsome Therapeutics reported strong double-digit product revenue growth in its latest quarter, with Auvelity revenue soaring 59% to $153 million and Sunosi revenue climbing 34% to $33 million. The company recently won approval for Auvelity to treat agitation associated with Alzheimer’s disease and launched Symbravo for migraine relief, with doctors writing about 17,000 prescriptions for Symbravo in the first quarter. Axsome also has a late-stage pipeline that includes AXS-12 for narcolepsy under regulatory review and solriamfetol in phase three trials for four indications. Despite the growth, a $1,000 investment would need a 500% gain to reach $6,000, implying a trillion-dollar market value for Axsome, making it unlikely to be a millionaire-maker stock on its own.

Axsome Therapeutics has dosed the first patient in its FOCUS-3 Phase 3 trial evaluating solriamfetol as a treatment for adolescents with attention deficit hyperactivity disorder. The randomized, double-blind, placebo-controlled, multicenter study will enroll approximately 468 patients aged 12 to less than 18 years, randomized equally to one of two doses of solriamfetol or placebo for six weeks. The primary endpoint is the change from baseline to week 6 in the ADHD Rating Scale total score. Solriamfetol is a dopamine and norepinephrine reuptake inhibitor also being developed for major depressive disorder with excessive daytime sleepiness, binge eating disorder, and shift work disorder.