Axsome Therapeutics, Inc. (AXSM) Stock Analysis
Breakout setup
Healthcare · Biotechnology
Sell if holding. Engine safety override at $252.66: Quality below floor (3.8 < 4.0) triggers a hard block regardless of the otherwise-positive setup — overall score 5.5/10. Specifically: Below-average business quality; Rich valuation.
Axsome Therapeutics markets three FDA-approved CNS medicines in the U.S. — AUVELITY for MDD (approved August 2022), SUNOSI for excessive daytime sleepiness (acquired 2022), and SYMBRAVO for acute migraine (approved January 2025) — which together generated $638.5 million in... Read more
Sell if holding. Engine safety override at $252.66: Quality below floor (3.8 < 4.0) triggers a hard block regardless of the otherwise-positive setup — overall score 5.5/10. Specifically: Below-average business quality; Rich valuation. Chart setup: Golden cross, above all MAs, RSI 67, MACD bullish. Score 5.5/10, moderate confidence.
Passes 6/7 gates (positive momentum, clean insider activity, no SEC red flags, earnings proximity 48d clear, semi cycle peak clear, materials cycle peak clear). Fails on favorable risk/reward ratio. Suitability: moderate.
About Axsome Therapeutics, Inc.
About Axsome Therapeutics, Inc.
Axsome Therapeutics generated $638.5 million in combined revenue from three FDA-approved CNS products in 2025, representing 66% growth year-over-year: AUVELITY (approved August 2022 for major depressive disorder), SUNOSI (acquired 2022 for excessive daytime sleepiness in patients with obstructive sleep apnea or narcolepsy), and SYMBRAVO (approved January 2025 for acute migraine). The lead pipeline asset, AXS-05, received Priority Review designation from the FDA in December 2025 for Alzheimer's disease agitation, with a PDUFA target action date of April 30, 2026.
Axsome commercializes all three approved products directly in the United States through a focused sales and marketing organization, targeting approximately 21 million U.S. MDD patients, 22 million adults with obstructive sleep apnea or narcolepsy, and 39 million adults experiencing migraine. SUNOSI's ex-U.S. rights outside 12 Asian markets — retained by originator SK Biopharmaceuticals — are licensed to Pharmanovia under a 2023 agreement covering Europe and parts of the Middle East and North Africa. Manufacturing is outsourced to third-party contract manufacturers under non-exclusive commercial supply agreements with no material contractual obligations beyond ordered supply. The company carries a credit facility with Blackstone Alternative Credit Advisors providing up to $570.0 million in term and revolving credit — closed May 8, 2025, bearing interest at SOFR plus 4.75% and maturing May 8, 2030.
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The primary near-term binary risk is the FDA decision on AXS-05 for Alzheimer's disease agitation. The FDA granted Priority Review and Breakthrough Therapy designation for this indication. Across four Phase 3 trials, three met their primary endpoint and one did not, providing mixed but largely positive efficacy data. If the FDA declines approval, the commercial trajectory of the company's self-described lead product candidate could be materially disrupted. A parallel setback illustrates pipeline-wide regulatory exposure: the AXS-14 fibromyalgia NDA received a Refusal to File letter in 2025 because one pivotal trial used an endpoint structure the FDA deemed inadequate, with the FORWARD Phase 3 trial now underway to address the deficiency.
See also: Healthcare · Biotechnology
From Axsome Therapeutics, Inc.'s most recent 10-K filing, extracted June 9, 2026.
Recent developments
updated 2026-06-15Recent Developments — Axsome Therapeutics, Inc.
Latest news
- NEWS Axsome to Present New Sleep Disorder Data at SLEEP 2026, To Highlight AXS-12 and Solriamfetol Data for Narcolepsy and OS — benzinga Jun 15, 2026 positive
- NEWS 10 Health Care Stocks Whale Activity In Today's Session — benzinga Jun 5, 2026 neutral
- NEWS Axsome Therapeutics Presents New SYMBRAVO Data At AHS 68th Annual Scientific Meeting — benzinga Jun 4, 2026 positive
- NEWS Axsome Therapeutics Resolves All Patent Litigation Related To Axsome's Product SUNOSI — benzinga Jun 3, 2026 positive
- NEWS Axsome Therapeutics Presents New AUVELITY Data In Major Depressive Disorder At ASCP 2026 Annual Meeting — benzinga May 26, 2026 positive
Generated 2026-06-15T18:11:46Z.
Upcoming dated catalysts
Thesis
Key Metrics
Quality Signals
Options Flow
Concentration Risks(10-K Item 1A)
- MEDIUMpipelineAXS-05 for Alzheimer's disease agitation10-K Item 1: 'Our lead product candidate, AXS-05 (dextromethorphan and bupropion), is currently being developed for the treatment of Alzheimer's disease (AD) agitation'
Model-generated analysis — not investment advice. Not a registered investment advisor. Past performance does not guarantee future results.
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Rating Breakdown
5 floor-breakers·1 ceiling hit
Ranks in the bottom of its industry peers on the composite signal. Better names in the same sector exist.static
Priced at a premium — multiples above sector norms. Needs delivery on growth + margins to justify.static
Clinical-stage biotech: losses expected pre-commercialisation. Quality floor doesn't distinguish R&D investment from operational decay — components above tell the real story.static
Technicals below the gate floor. Component breakdown shows what dragged the score down.static
No near-term catalyst priced in. Thesis progression will come from fundamentals grinding, not event reaction.static
Price Targets
Position Sizing
Risk Alerts
Earnings
Verdict History
Frequently Asked Questions
Sell if holding. Engine safety override at $252.66: Quality below floor (3.8 < 4.0) triggers a hard block regardless of the otherwise-positive setup — overall score 5.5/10. Specifically: Below-average business quality; Rich valuation. Chart setup: Golden cross, above all MAs, RSI 67, MACD bullish. Prior stop was $235.12. Score 5.5/10, moderate confidence.
Take-profit target: $252.77 (0.0% upside). Prior stop was $235.12. Stop-loss: $235.12.
Target reached (-1.9% upside); Quality below floor (3.8 < 4.0).
Axsome Therapeutics, Inc. trades at a P/E of N/A (forward 43.3). TrendMatrix value score: 3.3/10. Verdict: Sell.
27 analysts cover AXSM with a consensus score of 4.3/5. Average price target: $275.
What does Axsome Therapeutics, Inc. do?Axsome Therapeutics markets three FDA-approved CNS medicines in the U.S. — AUVELITY for MDD (approved August 2022),...
Axsome Therapeutics markets three FDA-approved CNS medicines in the U.S. — AUVELITY for MDD (approved August 2022), SUNOSI for excessive daytime sleepiness (acquired 2022), and SYMBRAVO for acute migraine (approved January 2025) — which together generated $638.5 million in revenue for 2025, representing 66% annual growth. The pipeline is anchored by AXS-05 for Alzheimer's disease agitation, with Priority Review designation and a PDUFA target date of April 30, 2026.