Yeji

$AXSM

Axsome Therapeutics, Inc.

Runway:44 mo
NasdaqMarket cap: —CIK 0001579428

Upcoming catalysts

4 surfaced
FDA approvalDate TBD~ low confidence
$AXSMAxsome Therapeutics, Inc.
“a dual-acting dopamine and norepinephrine reuptake inhibitor indicated to improve wakefulness in adult patients living with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea, which was approved by the U.S. Food and Drug Administration ("FDA") in 2019”
CRLDate TBD
$AXSMAxsome Therapeutics, Inc.
axs-07 · acute treatment of migraine
“Axsome received a Complete Response Letter (CRL) from the FDA regarding its NDA for AXS-07 for the acute treatment of migraine. The CRL did not identify or raise any concerns about the clinical efficacy or safety data in the NDA and the FDA did not request any new clinical trials to support the approval of AXS-07. The principal reasons given in the CRL relate to chemistry, manufacturing, and controls (CMC) considerations.”
NDA/BLA filedDate TBD
$AXSMAxsome Therapeutics, Inc.
symbravo
“On August 19, 2025, Axsome Therapeutics, Inc. (the "Company") received a Paragraph IV Certification Notice Letter (the "Notice Letter") from Apotex Inc. ("Apotex"), providing notification to the Company that Apotex has submitted an Abbreviated New Drug Application ("ANDA") to the U.S. Food and Drug Administration ("FDA") seeking approval to manufacture, use, or sell a generic version of Symbravo ® (meloxicam-rizatriptan benzoate).”
NDA/BLA filedDate TBD
$AXSMAxsome Therapeutics, Inc.
axs-07 · acute treatment of migraine
“the U.S. Food and Drug Administration has accepted for filing the Company's New Drug Application for AXS-07 for the acute treatment of migraine.”

Drug pipeline

symbravo
auvelity
axs-07
acute treatment of migraine
axs-05
major depressive disorder
axs-14
Management of fibromyalgia
sunosi
excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea
AXS-07 (MoSEIC meloxicam and rizatriptan)
Migraine
Solriamfetol 300 mg
Major Depressive Disorder
AXS-02 (oral zoledronate)
Complex Regional Pain Syndrome
Solriamfetol 150 mg Oral Tablet
Narcolepsy
Solriamfetol 75mg, 150 mg, or 300 mg
Binge-Eating Disorder
Solriamfetol 150 mg
ADHD
Solriamfetol
Excessive Daytime Sleepiness
Sunosi (solriamfetol)
Narcolepsy
AXS-14 (Esreboxetine)
Fibromyalgia
AXS-05 (dextromethorphan and bupropion) oral tablets
Major Depressive Disorder
AXS-12 (reboxetine)
Narcolepsy
AXS-02
Osteoarthritis, Knee
AXS-05 (dextromethorphan-bupropion)
Agitation in Patients With Dementia of the Alzheimer's Type

Recent & active trials

NCTDrugPhaseStatusPrimary completion
NCT06413420Sunosi (solriamfetol)—Recruiting2029-09-01
NCT07484217Solriamfetol 150 mgPhase 3Recruiting2028-12-01
NCT07398417AXS-14 (Esreboxetine)Phase 3Recruiting2028-03-01
NCT06878976Solriamfetol 75mg, 150 mg, or 300 mgPhase 3Enrolling By Invitation2026-12-01
NCT06568367Solriamfetol 150 mgPhase 3Recruiting2026-12-01
NCT06223880axs-05Phase 4Recruiting2026-03-01
NCT06413433Solriamfetol 150 mgPhase 3Recruiting2025-12-01
NCT06736509axs-05Phase 3Terminated2025-02-17
NCT05972044Solriamfetol 150 mgPhase 3Completed2025-02-07
NCT06360419Solriamfetol 300 mgPhase 3Completed2024-12-31
NCT04947553axs-05Phase 3Completed2024-12-03
NCT05550207AXS-07 (MoSEIC meloxicam and rizatriptan)Phase 3Completed2024-11-27
NCT05557409axs-05Phase 3Completed2024-11-21
NCT05113745AXS-12 (reboxetine)Phase 3Completed2024-11-15
NCT05059223AXS-12 (reboxetine)Phase 3Completed2024-03-15
NCT04797715axs-05Phase 3Completed2022-11-21
NCT04789174SolriamfetolPhase 4Completed2022-09-19
NCT05008341Solriamfetol 150 mg Oral TabletPhase 1Completed2022-04-15
NCT04634669axs-05Phase 2Terminated2022-02-18
NCT04608396axs-05Phase 2Completed2021-07-30

Recent catalysts

FDA approvalApr 30, 2026· 37d ago· success
$AXSMAxsome Therapeutics, Inc.
auvelity
“openFDA SUPPL (EFFICACY) approval of AUVELITY — application NDA215430”
NDA/BLA filedDec 31, 2025· 157d ago· unknown
$AXSMAxsome Therapeutics, Inc.
“On December 31, 2025, Axsome Therapeutics, Inc. (the ”
CRLJun 9, 2025· 362d ago
$AXSMAxsome Therapeutics, Inc.
axs-14 · Management of fibromyalgia
“Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced it has received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for AXS-14 (esreboxetine) for the management of fibromyalgia.”
PDUFAJan 31, 2025· 491d ago
$AXSMAxsome Therapeutics, Inc.
axs-07 · acute treatment of migraine
“The FDA designated the resubmission as a Class 2 resubmission and set a Prescription Drug User Fee Act (PDUFA) action goal date of January 31, 2025.”
FDA approvalJan 30, 2025· 492d ago· success
$AXSMAxsome Therapeutics, Inc.
symbravo
“openFDA ORIG (TYPE 4) approval of SYMBRAVO — application NDA215431”
NDA/BLA filedSep 4, 2024· 640d ago· unknown
$AXSMAxsome Therapeutics, Inc.
axs-07 · acute treatment of migraine
“the U.S. Food and Drug Administration has acknowledged the resubmission of the Company's New Drug Application for AXS-07 for the acute treatment of migraine.”
FDA approvalAug 19, 2022· 1387d ago
$AXSMAxsome Therapeutics, Inc.
auvelity
“the U.S. Food and Drug Administration (FDA) has approved AUVELITY TM for the treatment of major depressive disorder (MDD) in adults.”
FDA approvalAug 18, 2022· 1388d ago· success
$AXSMAxsome Therapeutics, Inc.
auvelity
“openFDA ORIG (TYPE 3/4) approval of AUVELITY — application NDA215430”
PDUFAApr 30, 2022· 1498d ago· failure
$AXSMAxsome Therapeutics, Inc.
axs-07 · acute treatment of migraine
“the Company expects to receive a Complete Response Letter with respect to this NDA on or about the Prescription Drug User Fee Act target action date of April 30, 2022.”
CRLApr 30, 2022· 1498d ago
$AXSMAxsome Therapeutics, Inc.
axs-07 · acute treatment of migraine
“the Company expects to receive a Complete Response Letter with respect to this NDA on or about the Prescription Drug User Fee Act target action date of April 30, 2022.”
CRLApr 29, 2022· 1499d ago
$AXSMAxsome Therapeutics, Inc.
axs-07 · acute treatment of migraine
“On April 29, 2022, the Company received a Complete Response Letter (the \”
NDA/BLA filedSep 14, 2021· 1726d ago
$AXSMAxsome Therapeutics, Inc.
axs-07 · acute treatment of migraine
“the U.S. Food and Drug Administration (FDA) has accepted for filing the Company\'s New Drug Application (NDA) for AXS-07 for the acute treatment of migraine”
PDUFAAug 22, 2021· 1749d ago· unknown
$AXSMAxsome Therapeutics, Inc.
axs-05 · major depressive disorder
“the U.S. Food and Drug Administration informed the Company in a teleconference on August 20, 2021, that its review of the new drug application for AXS-05 for the treatment of major depressive disorder would not be completed by the Prescription Drug User Fee Act target action date of August 22, 2021.”
FDA approvalMar 20, 2019· 2635d ago
$AXSMAxsome Therapeutics, Inc.
sunosi · excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea
“Sunosi received U.S. Food and Drug Administration approval on March 20, 2019 to improve wakefulness in adult patients with EDS associated with narcolepsy or OSA”