Axsome Therapeutics, Inc.

What the company does

• Fully integrated biopharmaceutical company focused on developing medicines for central nervous system (CNS) disorders.
• Combines in-house discovery and development with proprietary medicinal chemistry and formulation technologies to create differentiated CNS therapies.
• Supports U.S. commercialization with its own sales and marketing infrastructure and pursues strategic partnerships for commercialization outside the U.S.

Commercial products

• AUVELITY® (dextromethorphan and bupropion)
  • Indication: treatment of major depressive disorder (MDD) in adults.
  • AUVELITY is the first and only oral NMDA receptor antagonist approved for MDD in adults with rapid-acting efficacy on the label.
• SUNOSI® (solriamfetol)
  • Indication: excessive daytime sleepiness (EDS) associated with obstructive sleep apnea or narcolepsy.
  • U.S. rights were acquired from Jazz Pharmaceuticals in 2022; ex-U.S. rights were also acquired in 2022; commercialization is ongoing.
• SYMBRAVO® (MoSEI™ meloxicam-rizatriptan)
  • Indication: acute treatment of migraine with or without aura in adults.
  • FDA approved in January 2025; U.S. launch in June 2025.
• Revenue context
  • Combined product revenues for AUVELITY, SUNOSI, and SYMBRAVO were $638.5 million in 2025, a 66% increase versus 2024.

Lead and development pipeline

• AXS-05 (dextromethorphan-bupropion)
  • Lead product candidate being developed for Alzheimer’s disease (AD) agitation and smoking cessation.
  • December 2025: FDA accepted an sNDA for AD agitation with Priority Review; PDUFA target date April 30, 2026.
• Solriamfetol (SUNOSI) expanded indications
  • Phase 3 programs in ADHD; MDD with EDS symptoms; binge eating disorder (BED); and excessive sleepiness associated with shift work disorder (SWD).
• AXS-12 (reboxetine)
  • Narcolepsy program with focus on cataplexy; FDA pre-NDA meeting minutes from December 2025 support NDA submission for cataplexy.
  • Orphan Drug Designation has been granted.
• AXS-14 (esreboxetine)
  • Fibromyalgia program developed after Pfizer license; NDA submission in 2025 received FDA adequacy questions and a FORWARD Phase 3 trial was initiated to address feedback.
• AXS-17 (AZD7325)
  • Epilepsy program; global rights acquired in November 2025 through the acquisition of Baergic Bio to pursue epilepsy indications.
• Other programs
  • Additional late-stage and earlier-stage candidates targeting various CNS conditions.

Commercial strategy and manufacturing

• Built a U.S.-focused commercial infrastructure and may pursue co-promotion or strategic partnerships to extend reach.
• Drug substance and product manufacturing is outsourced to contract manufacturing organizations (CMOs); the company does not own manufacturing facilities.
• CMOs are periodically audited for quality; supply arrangements with third parties support clinical and commercial needs.

Licensing, collaborations, and strategic assets

• Pfizer: exclusive U.S. license for reboxetine/esreboxetine data and U.S. development and commercial rights to AXS-12 and AXS-14 in fibromyalgia.
• Antecip Bioventures: license for AXS-05 with a 3.0% royalty on net sales; licenses extend country-by-country and terminate on the later of patent expiry or ten years from first commercial sale in a country.
• Jazz Pharmaceuticals, SK Biopharmaceuticals, and Aerial Biopharma: royalty framework tied to SUNOSI, with milestones up to $162.5 million, $1.0 million development milestones, and tiered royalties.
• Pharmanovia: licensed Europe and certain MENA markets for SUNOSI.
• Asset acquisitions (late 2025)
  • Baergic Bio, Inc.: acquired global rights to AXS-17 (AZD7325) for epilepsy; $2.3 million upfront; contingent milestones up to $159.5 million plus tiered royalties.
  • DeuteRx, LLC: acquired deuterium-stabilized S-bupropion; contingent milestones up to $523 million; tiered low single-digit royalties.

Intellectual property, exclusivity, and regulatory landscape

• Patent portfolio includes over 600 issued patents and more than 450 pending applications worldwide.
• Primary protection: AXS-05 (AUVELITY) through the 2040s, AXS-07 (SYMBRAVO) through the 2040s, AXS-12 through 2039; SUNOSI has Orange Book protection through 2042.
• Uses data exclusivity, settlements, and exclusivity arrangements to manage generic competition.
• Engages regulatory pathways including 505(b)(2) options, orphan drug designations, and expedited review programs such as Fast Track, Priority Review, and Breakthrough Therapy where applicable.
• Faces industry-standard risks around patent challenges, regulatory approvals, and post-approval compliance.