Highest-materiality recent filing
Axsome Q2 2026 revenue up 46% to $218.4M; AUVELITY Alzheimer's launch underway
Total net product revenue $218.4M, +46% YoY; AUVELITY sales $180.3M (+51% YoY), SUNOSI $35.8M (+20%), SYMBRAVO $2.3M (+461%).
FDA accepts Axsome's NDA for AXS-12 (reboxetine) for cataplexy in narcolepsy; PDUFA May 1, 2027
FDA accepted for filing Axsome's New Drug Application for AXS-12 (reboxetine) to treat cataplexy in narcolepsy.
Axsome adopts Executive Severance Plan with CIC benefits for officers
Plan effective June 5, 2026, covers CEO (Tier 1), other Section 16 execs (Tier 2), and VPs+ (Tier 3).
Axsome shareholders elect directors, ratify Deloitte, approve say-on-pay at 2026 annual meeting
Mark Saad elected Class II director with 28,675,654 votes for, 10,286,822 withheld.
Axsome settles all SUNOSI patent litigation; generic entry deferred to 2040
Resolved all outstanding SUNOSI patent litigation with the last first-to-file generic applicant.
Axsome Q1 revenue $191.2M (+57% YoY); Auvelity approved for Alzheimer's agitation
Total net product revenue $191.2M (+57% YoY); Auvelity $153.2M (+59%), Sunosi $33.9M (+34%), Symbravo $4.1M.
Axsome Therapeutics announces FDA approval of AUVELITY for Alzheimer's disease agitation
AUVELITY (dextromethorphan HBr/bupropion HCl) approved for agitation associated with dementia due to Alzheimer's disease.
Axsome acquires global rights to PDE10A inhibitor balipodect from Takeda
Obtained exclusive worldwide rights to balipodect, a selective PDE10A inhibitor, from Takeda.
Axsome Q4 revenue $196M (+65% YoY); AXS-05 PDUFA set for April 30, 2026
Total net product revenue Q4 $196.0M, FY $638.5M (+66% YoY); AUVELITY sales $507.1M (+74%).
Axsome settles SUNOSI patent litigation; generic entry delayed to 2040
Alkem can sell generic SUNOSI on/after March 1, 2040 (no pediatric exclusivity) or September 1, 2040 (if granted), subject to FDA approval.
Total preliminary 4Q net product revenue $196.0M (+65% YoY); full year $638.5M (+66% YoY).
FDA accepted sNDA for AXS-05 (dextromethorphan/bupropion) for Alzheimer's agitation; Priority Review with PDUFA date April 30, 2026.
Total net product revenue $171.0M (63% YoY growth); AUVELITY $136.1M (+69%), SUNOSI $32.8M (+35%), SYMBRAVO $2.1M (first full quarter).
Axsome receives ANDA Paragraph IV notice from Apotex for generic Symbravo
Apotex filed an ANDA seeking FDA approval to market a generic version of Symbravo (meloxicam-rizatriptan benzoate).
Axsome Q2 product revenue $150M (+72% YoY); AUVELITY sales $119.6M
Total net product revenue $150.0M, up 72% YoY and 24% sequentially.
Axsome launches SYMBRAVO for acute migraine treatment in U.S.
SYMBRAVO (meloxicam/rizatriptan) now available by prescription for acute migraine with or without aura in adults.
FDA refuses to file Axsome's NDA for AXS-14 (esreboxetine) for fibromyalgia; new trial required
FDA issued RTF letter; second placebo-controlled trial deemed inadequate due to 8-week endpoint and flexible-dose design.
Axsome stockholders approve all four proposals at 2025 annual meeting
Elected Roger A. Jeffs as Class I director with 27.3M votes for, 8.1M withheld.
Axsome settles SUNOSI patent litigation with Hetero; generic entry delayed until 2040
Settlement resolves patent litigation with Hetero over generic version of SUNOSI (solriamfetol).
Axsome enters $570M credit facility with Blackstone, retires Hercules loan
New $570M facility includes a $500M term loan (SOFR+4.75%) and a $70M revolver (SOFR+4.00%).
Axsome Q1 total net product revenue $121.5M (+62% YoY); SYMBRAVO launch on track for June 2025
Total net product revenue $121.5M (+62% YoY); AUVELITY $96.2M (+80%) and SUNOSI $25.2M (+17%).
Primary endpoint (change in MADRS total score) not met in overall MDD population.
Axsome solriamfetol Phase 3 ADHD trial meets primary endpoint (p=0.039)
AISRS total score reduced 17.7 pts vs 14.3 for placebo at Week 6 (p=0.039) with 150 mg dose.
Axsome settles Sunosi patent litigation with Hikma; generic entry deferred to 2040
Settlement with Hikma resolves patent litigation over Sunosi (solriamfetol) generic.
Axsome gets FDA support for AXS-05 sNDA in Alzheimer's agitation; filing planned 3Q 2025
FDA pre-NDA meeting minutes confirm existing data package supports supplemental NDA submission for AXS-05.
Total net product revenue FY24 $385.7M (+88%); Q4 $118.8M (+66% YoY).
Axsome settles AUVELITY patent litigation with Teva; generic entry no earlier than 2038-2039
Settlement grants Teva license to sell generic AUVELITY starting Mar 31, 2039 (if pediatric exclusivity) or Sep 30, 2038 (if not).
Axsome receives FDA approval for SYMBRAVO (meloxicam/rizatriptan) for acute migraine in adults
SYMBRAVO approved by FDA for acute treatment of migraine; expected commercially available in ~4 months.
Axsome announces preliminary FY2024 revenue $385.2M; Auvelity $291.4M
Total product revenue Q4 $118.3M, full year $385.2M (unaudited preliminary).
ACCORD-2 met primary endpoint: time to relapse delayed (HR=0.276, p=0.001); 3.6-fold lower relapse risk vs placebo.
Axsome's AXS-12 meets primary endpoint in ENCORE Phase 3 trial for narcolepsy with cataplexy
Primary endpoint met: AXS-12 significantly reduced cataplexy attacks vs placebo (p=0.017); placebo worsening +10.29 attacks/week vs +1.32 with AXS-12.
Axsome Q3 revenue $104.8M (+81% YoY); Auvelity $80.4M (+113%); net loss $64.6M
Total net product revenue $104.8M, up 81% YoY; Auvelity $80.4M (+113%), Sunosi $24.4M (+21%).
Axsome amends Hercules loan: Tranche 3 raised to $80M, covenants eased
Fifth Amendment increases Tranche 3 commitment from $75M to $80M.
FDA accepts Axsome's NDA resubmission for AXS-07 migraine treatment; PDUFA date Jan 31, 2025
FDA acknowledged Class 2 resubmission of NDA for AXS-07 for acute migraine treatment.
Axsome and Sandoz dismiss Sunosi patent litigation; Sandoz withdraws generic ANDA
Sandoz withdrew its ANDA for a generic equivalent of Sunosi (solriamfetol), leading to dismissal of patent litigation without prejudice.
Axsome Q2 revenue $87.2M (+87% YoY); Auvelity sales $65.0M (+135%)
Total net product revenue $87.2M, up 87% YoY; Auvelity $65.0M (+135%), Sunosi $22.1M (+16%).
Re-elected Herriot Tabuteau (33.3M for, 0.5M withheld) and Mark Coleman (27.1M for, 6.7M withheld) as Class III directors.
Axsome settles Sunosi patent litigation with Unichem; generic entry June 30, 2042
Settlement resolves Hatch-Waxman litigation over Sunosi (solriamfetol) following Unichem's ANDA.
Axsome Q1 net product revenue $75M (+160% YoY); net loss $68.4M; pipeline milestones on track
Auvelity net sales $53.4M (+240% YoY); Sunosi net revenue $21.6M (+64% YoY).
Axsome initiates Phase 3 ENGAGE trial of solriamfetol for binge eating disorder
Initiated ENGAGE Phase 3 trial of solriamfetol for binge eating disorder.
Axsome Therapeutics Announces AXS-12 Meets Primary Endpoint in Phase 3 SYMPHONY Trial for Narcolepsy
AXS-12 reduced weekly cataplexy attacks by 83% vs 66% for placebo (p=0.018) at Week 5.
Axsome CRESCENDO survey: 77% of treated NT1 patients still have cataplexy; 74% cognitive impairment
77% of treated NT1 patients continue to experience cataplexy attacks despite current therapy.
Axsome doses first patient in PARADIGM Phase 3 trial of solriamfetol for MDD
First patient dosed in Phase 3 PARADIGM trial of solriamfetol for major depressive disorder.
Axsome Q4 2023 net product revenue $71.5M (+193% YoY); net loss $98.7M; pipeline milestones on track
Total net product revenue $71.5M in Q4 2023 (+193% YoY); full year $204.9M (+309% YoY).
Axsome Therapeutics updates corporate presentation on February 20, 2024
Company posted updated corporate presentation to its website on February 20, 2024.
Axsome updates corporate presentation; no financial details disclosed in filing
Axsome Therapeutics filed an 8-K on Jan 8, 2024, to announce an updated corporate presentation.
Axsome reports preliminary Q4 net product revenue of $71M; full year $204M
Preliminary total net product revenue: $71M for Q4 2023, $204M for full year 2023.
Virtual investor event held Dec 7, 2023, featuring five physician thought leaders discussing solriamfetol.
Axsome Q3 product revenue $57.8M (up 244% YoY); Auvelity sales $37.7M
Total Q3 product revenue was $57.8M vs $16.8M in Q3 2022; Auvelity net sales $37.7M (36% sequential growth).
Axsome Therapeutics appoints Dr. Susan Mahony to board of directors
Board expanded from 4 to 5 directors; Dr. Mahony appointed effective Oct. 10, 2023.
The Board of Directors (the “Board”) of Axsome Therapeutics, Inc. (the “Company”), increased the size of the Board from four to five directors, and on October 8, 2023 appointed Dr. Susan Mahony as a director to be effective as of October 10, 2023 (the “Effective Date”).
Max materiality 0.90 · Median 0.75 · Most common event other_material