AXSM · Axsome Therapeutics, Inc.

💊 Upcoming FDA Decisions

PoA = estimated probability of approval: base rates calibrated against BioRadar's verified FDA outcomes, adjusted for application type, modality, therapy area and cash runway. Not investment advice. See the full PDUFA calendar →

📣 What AXSM Says Is Next

• in 2027 · Solriamfetol: “The Company anticipates topline results from the SUSTAIN Phase 3 trial in 2027.”
  Company press release, Aug 10, 2026 · SEC filing
• fourth quarter of 2026 · Solriamfetol: “The Company anticipates topline results from the ENGAGE Phase 3 trial in the fourth quarter of 2026.”
  Company press release, Aug 10, 2026 · SEC filing
• in 2026 · “Schizophrenia: Phase 3 trial-enabling activities for AXS-20 in schizophrenia are anticipated in 2026.”
  Company press release, May 4, 2026 · SEC filing

Quoted word for word from the company's press releases filed with the SEC. Timing is the company's own guidance, not a BioRadar estimate.

🧪 Trial & FDA Catalysts

• Dec 2026 · Phase 3 · Recruiting · Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Dis
  Registry primary completion date, not a results date
• Dec 2026 · Phase 3 · Recruiting · Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfet
  Registry primary completion date, not a results date
• Dec 2027 · Phase 3 · Enrolling · A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge
  Registry primary completion date, not a results date
• Dec 2027 · Phase 3 · Enrolling · An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolesc
  Registry primary completion date, not a results date
• Dec 2027 · Phase 3 · Recruiting · Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
  Registry primary completion date, not a results date
• Mar 2028 · Phase 3 · Recruiting · Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research D
  Registry primary completion date, not a results date

📊 Drug Pipeline

Also used in these trials (approved or third-party drugs, not AXSM's own candidates): Meloxicam, Bupropion Hydrochloride.

Source: ClinicalTrials.gov trials sponsored by the company, one row per candidate at its most advanced registered trial. FDA approvals: Drugs@FDA. Wrong or missing drug? Report it

💰 Cash Runway & Dilution Risk

AXSM holds $319.9M in cash and short-term investments (as of Jun 30, 2026) and burns about $26.8M/quarter from operations, an estimated runway of 35.8 months at that rate (BioRadar estimate, not company guidance).

Dilution pressure: 25 · Moderate

• Cash runway 36 months
• ATM program on file since Nov 2025 +15
• Shelf registration (S-3ASR, Nov 2025) +10

Recent financing filings on SEC EDGAR:

• Nov 3, 2025 · Shelf registration with ATM program, up to $250M · S-3ASR
• May 13, 2025 · Private placement (8-K Item 3.02) · 8-K

Source: SEC EDGAR (XBRL cash flow and financing filings). Dilution Watch: every company ranked → · Get an alert when AXSM files for a raise →

👥 Who Owns AXSM

Share count 52,380,818 (latest 10-Q/10-K). Insiders: each officer's, director's and 10% owner's latest Form 3, 4 or 5, direct and indirect shares; options are not counted. 5%+ holders: latest Schedule 13D or 13G of each holder above 5%. Institutions: the total held by all 13F filers (Yahoo Finance); the table lists the largest (13F quarter ending 2026-06-30). Sources have different dates, so the split is approximate. Source: SEC EDGAR.

📈 Recent Insider Activity (Form 4)

Only open-market purchases (P) and sales (S) are trading decisions. Awards (A), option exercises (M) and tax withholding (F) are compensation mechanics. Source: SEC Form 4.

📅 Past FDA Decisions & Stock Reactions

Browse all historical PDUFA outcomes →