Recent 8-K filings for AXSM
Highest-materiality recent filing
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.
- In MOMENTUM trial, 77% of patients did not require rescue medication within 24h; superior to rizatriptan on sustained pain freedom.
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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.
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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.
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Axsome acquires global rights to PDE10A inhibitor balipodect from Takeda
Obtained exclusive worldwide rights to balipodect, a selective PDE10A inhibitor, from Takeda.
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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%).
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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.
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Total preliminary 4Q net product revenue $196.0M (+65% YoY); full year $638.5M (+66% YoY).
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FDA accepted sNDA for AXS-05 (dextromethorphan/bupropion) for Alzheimer's agitation; Priority Review with PDUFA date April 30, 2026.
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Total net product revenue $171.0M (63% YoY growth); AUVELITY $136.1M (+69%), SUNOSI $32.8M (+35%), SYMBRAVO $2.1M (first full quarter).
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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).
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Axsome Q2 product revenue $150M (+72% YoY); AUVELITY sales $119.6M
Total net product revenue $150.0M, up 72% YoY and 24% sequentially.
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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.
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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.
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Axsome settles SUNOSI patent litigation with Hetero; generic entry delayed until 2040
Settlement resolves patent litigation with Hetero over generic version of SUNOSI (solriamfetol).
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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%).
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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%).
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Primary endpoint (change in MADRS total score) not met in overall MDD population.
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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.
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Axsome settles Sunosi patent litigation with Hikma; generic entry deferred to 2040
Settlement with Hikma resolves patent litigation over Sunosi (solriamfetol) generic.
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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.
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Total net product revenue FY24 $385.7M (+88%); Q4 $118.8M (+66% YoY).
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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).
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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.
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Axsome announces preliminary FY2024 revenue $385.2M; Auvelity $291.4M
Total product revenue Q4 $118.3M, full year $385.2M (unaudited preliminary).
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ACCORD-2 met primary endpoint: time to relapse delayed (HR=0.276, p=0.001); 3.6-fold lower relapse risk vs placebo.
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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.
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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%).
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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.
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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.
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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%).
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Axsome settles Sunosi patent litigation with Unichem; generic entry June 30, 2042
Settlement resolves Hatch-Waxman litigation over Sunosi (solriamfetol) following Unichem's ANDA.
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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).
Earnings & guidance
Materiality & sentiment trend
Max materiality 0.90 · Median 0.75 · Most common event earnings