Recent 8-K filings for AXSM

• May 4, 2026, 7:59 PM ET earnings materiality 0.85 positive item 2.02item 8.01item 9.01 ◈ Earnings Releases

  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.

• April 30, 2026, 7:59 PM ET regulatory materiality 0.85 positive item 8.01item 9.01

  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.

• April 1, 2026, 7:59 PM ET M&A materiality 0.85 positive item 8.01item 9.01

  Axsome acquires global rights to PDE10A inhibitor balipodect from Takeda

  Obtained exclusive worldwide rights to balipodect, a selective PDE10A inhibitor, from Takeda.

• February 23, 2026, 6:59 PM ET earnings materiality 0.85 positive item 2.02item 9.01

  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%).

• February 17, 2026, 6:59 PM ET other material materiality 0.75 positive item 8.01item 9.01

  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.

• January 12, 2026, 6:59 PM ET earnings materiality 0.75 positive item 2.02item 8.01item 9.01

  Axsome reports preliminary 4Q and FY 2025 net product revenue of $196M and $638.5M, up 65% and 66% YoY

  Total preliminary 4Q net product revenue $196.0M (+65% YoY); full year $638.5M (+66% YoY).

• December 31, 2025, 6:59 PM ET regulatory materiality 0.75 positive item 8.01item 9.01

  FDA grants Priority Review to AXS-05 for Alzheimer's agitation; pre-NDA meeting supports AXS-12 narcolepsy filing

  FDA accepted sNDA for AXS-05 (dextromethorphan/bupropion) for Alzheimer's agitation; Priority Review with PDUFA date April 30, 2026.

• November 3, 2025, 6:59 PM ET earnings materiality 0.80 positive item 2.02item 8.01item 9.01

  Axsome Q3 2025 net product revenue $171M, up 63% YoY; submits sNDA for AXS-05 in Alzheimer's agitation

  Total net product revenue $171.0M (63% YoY growth); AUVELITY $136.1M (+69%), SUNOSI $32.8M (+35%), SYMBRAVO $2.1M (first full quarter).

• August 20, 2025, 7:59 PM ET litigation materiality 0.80 negative item 8.01item 9.01

  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).

• August 4, 2025, 7:59 PM ET earnings materiality 0.80 positive item 2.02item 8.01item 9.01

  Axsome Q2 product revenue $150M (+72% YoY); AUVELITY sales $119.6M

  Total net product revenue $150.0M, up 72% YoY and 24% sequentially.

• June 10, 2025, 7:59 PM ET other material materiality 0.60 positive item 8.01item 9.01

  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.

• June 9, 2025, 7:59 PM ET regulatory materiality 0.75 negative item 8.01item 9.01

  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.

• June 9, 2025, 7:59 PM ET other materiality 0.10 neutral item 5.07item 9.01

  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.

• May 27, 2025, 7:59 PM ET other material materiality 0.75 positive item 8.01item 9.01

  Axsome settles SUNOSI patent litigation with Hetero; generic entry delayed until 2040

  Settlement resolves patent litigation with Hetero over generic version of SUNOSI (solriamfetol).

• May 13, 2025, 7:59 PM ET debt materiality 0.80 positive item 1.01item 1.02item 2.03item 3.02item 8.01item 9.01

  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%).

• May 5, 2025, 7:59 PM ET earnings materiality 0.75 positive item 2.02item 8.01item 9.01

  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%).

• April 1, 2025, 7:59 PM ET other material materiality 0.65 neutral item 8.01item 9.01

  Axsome's solriamfetol misses primary endpoint in Phase 3 MDD trial; subgroup with severe EDS shows improvement

  Primary endpoint (change in MADRS total score) not met in overall MDD population.

• March 25, 2025, 7:59 PM ET other material materiality 0.85 positive item 8.01item 9.01

  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.

• March 5, 2025, 6:59 PM ET litigation materiality 0.75 positive item 8.01item 9.01

  Axsome settles Sunosi patent litigation with Hikma; generic entry deferred to 2040

  Settlement with Hikma resolves patent litigation over Sunosi (solriamfetol) generic.

• March 3, 2025, 6:59 PM ET regulatory materiality 0.75 positive item 8.01item 9.01

  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.

• February 18, 2025, 6:59 PM ET earnings materiality 0.80 positive item 2.02item 8.01item 9.01

  Axsome Q4/FY24 revenue $118.8M/$385.7M; Auvelity growth 124% YoY; Symbravo approved; pipeline NDA submissions on track

  Total net product revenue FY24 $385.7M (+88%); Q4 $118.8M (+66% YoY).

• February 10, 2025, 6:59 PM ET litigation materiality 0.85 neutral item 8.01item 9.01

  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).

• January 31, 2025, 6:59 PM ET regulatory materiality 0.90 positive item 8.01item 9.01

  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.

• January 13, 2025, 6:59 PM ET earnings materiality 0.75 positive item 2.02item 8.01item 9.01

  Axsome announces preliminary FY2024 revenue $385.2M; Auvelity $291.4M

  Total product revenue Q4 $118.3M, full year $385.2M (unaudited preliminary).

• December 30, 2024, 6:59 PM ET other material materiality 0.75 neutral item 8.01item 9.01

  Axsome AXS-05 succeeds in ACCORD-2 Phase 3 for Alzheimer's agitation; ADVANCE-2 misses primary endpoint

  ACCORD-2 met primary endpoint: time to relapse delayed (HR=0.276, p=0.001); 3.6-fold lower relapse risk vs placebo.

• November 26, 2024, 6:59 PM ET other material materiality 0.90 positive item 8.01item 9.01

  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.

• November 12, 2024, 6:59 PM ET earnings materiality 0.75 positive item 2.02item 8.01item 9.01

  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%).

• October 1, 2024, 7:59 PM ET debt materiality 0.55 positive item 1.01item 9.01

  Axsome amends Hercules loan: Tranche 3 raised to $80M, covenants eased

  Fifth Amendment increases Tranche 3 commitment from $75M to $80M.

• September 4, 2024, 7:59 PM ET regulatory materiality 0.70 positive item 8.01item 9.01

  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.

• August 21, 2024, 7:59 PM ET litigation materiality 0.65 positive item 8.01item 9.01

  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.

• August 5, 2024, 7:59 PM ET earnings materiality 0.75 positive item 2.02item 9.01

  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%).

• June 11, 2024, 7:59 PM ET other material materiality 0.10 neutral item 5.07item 9.01

  Axsome Therapeutics stockholders elect directors, ratify auditor, approve executive compensation at 2024 annual meeting

  Re-elected Herriot Tabuteau (33.3M for, 0.5M withheld) and Mark Coleman (27.1M for, 6.7M withheld) as Class III directors.

• June 5, 2024, 7:59 PM ET other material materiality 0.65 positive item 8.01item 9.01

  Axsome settles Sunosi patent litigation with Unichem; generic entry June 30, 2042

  Settlement resolves Hatch-Waxman litigation over Sunosi (solriamfetol) following Unichem's ANDA.

• May 6, 2024, 7:59 PM ET earnings materiality 0.65 neutral item 2.02item 9.01 ◈ Earnings Releases

  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

26 positive 2 negative 6 neutral

source · AXSM on sec.gov