Name in SEC filings: Axsome Therapeutics, Inc.
| Program | Event | Stage | Stated timing | Filing |
|---|---|---|---|---|
| AXS-14 | submission | — | 2025 | 8-K · |
| AXS-05 | NDA/BLA submission | — | 3Q 2025 | 8-K · |
| AXS-12 | NDA/BLA submission | — | 1Q 2026 | 8-K · |
| AXS-05 | target date (company stated) | PDUFA | April 30, 2026 | SEC filing · |
| solriamfetol | /data readout | Phase 3 | 4Q 2026 | EX-99.1 · |
| AXS-12 (reboxetine) | PDUFA target date (company stated) | PDUFA | May 1, 2027 | SEC filing · |
| solriamfetol | Topline/data readout | Phase 3 | 2027 | EX-99.1 · |
Source: ORION, orionbiotechai.com/company/AXSM, data as of Oct 13, 2026
https://www.orionbiotechai.com/company/AXSM
solriamfetol · Topline/data readout · 4Q 2026
SEC sources last checked .
○ Quote matched to filing (not yet reviewed by founder) · ✓ Checked by founder.
fibromyalgia
NDA/BLA submission1Q 2025
Stage: —
Public float: $4,400,000,000 · as of · SEC filing
NDA submission for AXS-14 in fibromyalgia (1Q 2025)
8-K · Filed · Last checked
Resolution filing: · SEC filing
Alert me · Calendar: same stage and window-end month (2025-03)
Alzheimer’s disease agitation
NDA/BLA submission3Q 2025
Stage: —
Public float: $4,400,000,000 · as of · SEC filing
sNDA submission for AXS-05 in Alzheimer’s disease agitation on track for 3Q 2025
8-K · Filed · Last checked
Resolution filing: · SEC filing
Alert me · Calendar: same stage and window-end month (2025-09)
cataplexy in narcolepsy
NDA/BLA submission1Q 2026
Stage: —
Public float: $4,400,000,000 · as of · SEC filing
AXS-12 for narcolepsy, NDA submission (1Q 2026)
8-K · Filed · Last checked
Resolution filing: · SEC filing
Alert me · Calendar: same stage and window-end month (2026-03)
agitation associated with Alzheimer disease dementia
PDUFA target date (company stated)April 30, 2026
Stage: PDUFASEC filing · “PDUFA target action date”
Public float: $4,400,000,000 · as of · SEC filing
PDUFA target action date of April 30, 2026
SEC filing · Filed · Last checked
Resolution filing: · SEC filing
Alert me · Calendar: same stage and window-end month (2026-04)
Topline/data readout4Q 2026
Stage: Phase 3SEC filing · “Phase 3”
Public float: $4,400,000,000 · as of · SEC filing
Clinical Trial Topline Results: o Phase 3 ENGAGE trial of solriamfetol in binge eating disorder (4Q 2026)
EX-99.1 · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2026-12)
cataplexy in narcolepsy
PDUFA target date (company stated)May 1, 2027
Stage: PDUFASEC filing · “PDUFA) target action date”
Public float: $4,400,000,000 · as of · SEC filing
Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027
SEC filing · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2027-05)
Topline/data readout2027
Stage: Phase 3SEC filing · “Phase 3; Phase 3”
Public float: $4,400,000,000 · as of · SEC filing
Clinical Trial Topline Results: o Phase 3 ENGAGE trial of solriamfetol in binge eating disorder (4Q 2026) o Phase 3 SUSTAIN trial of solriamfetol in shift work disorder (2027)
EX-99.1 · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2027-12)
Company periods and sentences are quoted as written. A matching disclosure uses the SEC filing date for the same program and event type. As of .
| Program / event | Stated period and SEC wording | Disclosure in stated period |
|---|---|---|
| AXS-12 (reboxetine)FDA decision | May 1, 2027“Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| AXS-12 (reboxetine)FDA decision | May 1, 2027“PDUFA target action date of May 1, 2027” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| AXS-12 (reboxetine)FDA decision | May 1, 2027“PDUFA target action (May 1, 2027” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| solriamfetolClinical results | 4Q 2026“Clinical Trial Topline Results: o Phase 3 ENGAGE trial of solriamfetol in binge eating disorder (4Q 2026)” Filed · EX-99.1 | Still within period As of Oct 19, 2026 |
| solriamfetolClinical results | 2027“Clinical Trial Topline Results: o Phase 3 ENGAGE trial of solriamfetol in binge eating disorder (4Q 2026) o Phase 3 SUSTAIN trial of solriamfetol in shift work disorder (2027)” Filed · EX-99.1 | Period not started The stated period has not started yet, so there is nothing to compare. |
| AXS-12 (reboxetine)FDA decision | May 1, 2027“Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| AXS-12 (reboxetine)FDA decision | May 1, 2027“PDUFA target action date of May 1, 2027” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| AXS-05FDA decision | April 30, 2026“PDUFA target action date of April 30, 2026” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| AXS-05FDA decision | April 30, 2026“Prescription Drug User Fee Act (PDUFA) date of April 30, 2026” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| AXS-05FDA decision | April 30, 2026“Prescription Drug User Fee Act (PDUFA) action goal date of April 30, 2026” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| AXS-05FDA decision | April 30, 2026“Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2026” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| AXS-05FDA decision | April 30, 2026“PDUFA target action (April 30, 2026” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| AXS-12Submission | 1Q 2026“AXS-12 for narcolepsy, NDA submission (1Q 2026)” Filed · EX-99.1 | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| AXS-05FDA decision | April 30, 2026“PDUFA action goal date of April 30, 2026” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| AXS-12Submission | in January 2026“Axsome anticipates completing the NDA submission in January 2026.” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| AXS-12Submission | in the fourth quarter of 2025“Axsome plans to submit an NDA to the FDA for AXS-12 for the treatment of cataplexy in narcolepsy in the fourth quarter of 2025.” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| AXS-12Submission | 4Q 2025“AXS-12 for narcolepsy, NDA submission (4Q 2025)” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| AXS-05Submission | 3Q 2025“sNDA submission for AXS-05 in Alzheimer’s disease agitation on track for 3Q 2025” Filed · EX-99.2 | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| AXS-05Submission | 3Q 2025“NDA submission for AXS-05 in Alzheimer’s disease agitation on track for 3Q 2025” Filed · EX-99.1 | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| AXS-05Submission | in the third quarter of 2025“Axsome is on track to submit the sNDA to the FDA in the third quarter of 2025.” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| AXS-05Submission | 3Q 2025“AXS-05 for Alzheimer’s disease agitation, sNDA submission (3Q 2025)” Filed · EX-99.1 | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| AXS-12Submission | 4Q 2025“NDA submission for AXS-12 for cataplexy in patients with narcolepsy anticipated in 4Q 2025” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| AXS-12Submission | in the fourth quarter of 2025“Axsome plans to submit an NDA to the FDA for AXS-12 for the treatment of cataplexy in narcolepsy in the fourth quarter of 2025.” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| AXS-12Submission | 4Q 2025“AXS-12 for narcolepsy, NDA submission (4Q 2025)” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| AXS-05Submission | in the third quarter of 2025“The Company is on track to submit the sNDA in the third quarter of 2025.” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| AXS-05Submission | 3Q 2025“NDA submission for AXS-05 in Alzheimer’s disease agitation on track for 3Q 2025” Filed · EX-99.1 | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| AXS-05Submission | 3Q 2025“AXS-05 for Alzheimer’s disease agitation, sNDA submission (3Q 2025)” Filed · EX-99.1 | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| AXS-12Submission | in the second half of 2025“The Company anticipates submitting an NDA to the FDA in the second half of 2025.” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| AXS-12Submission | 2025“NDA submission for AXS-12 for cataplexy in patients with narcolepsy anticipated in 2H 2025” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| AXS-12Submission | 2H 2025“AXS-12 for narcolepsy, NDA submission (2H 2025)” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| AXS-05Submission | in the third quarter of 2025“Axsome anticipates submitting the planned sNDA in the third quarter of 2025.” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| AXS-05Submission | in the second half of 2025“Based on the results from these studies, Axsome plans to submit a New Drug Application (NDA) for AXS-05 for the treatment of Alzheimer’s disease agitation to the FDA in the second half of 2025.” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| AXS-05Submission | 2H 2025“AXS-05 for Alzheimer’s disease agitation, NDA submission (2H 2025)” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| AXS-12Submission | in the second half of 2025“Based on the results from these studies, Axsome plans to submit an NDA for AXS-12 for the treatment of cataplexy in patients with narcolepsy to the FDA in the second half of 2025.” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| AXS-12Submission | 2H 2025“AXS-12 for narcolepsy, NDA submission (2H 2025)” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| AXS-14Submission | 1Q 2025“NDA submission for AXS-14 in fibromyalgia (1Q 2025)” Filed · EX-99.2 | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| AXS-14Submission | 1Q 2025“AXS-14 for fibromyalgia, NDA submission (1Q 2025)” Filed · EX-99.1 | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| AXS-05Submission | for the second half of 2025“planned NDA submission of AXS-05 in Alzheimer’s disease agitation, which is targeted for the second half of 2025.” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| AXS-05Submission | in the second half of 2025“Axsome plans to submit an NDA for AXS-05 in Alzheimer’s disease agitation to the FDA in the second half of 2025, based on the efficacy and safety data from these studies.” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| AXS-05Submission | in the second half of 2025“Axsome plans to submit an NDA for AXS-05 in Alzheimer’s disease agitation to the FDA in the second half of 2025, based on the efficacy and safety data from the above controlled and long-term studies.” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| AXS-14Submission | November 2024“NDA submission for AXS-14 for the management of fibromyalgia anticipated November 2024” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| AXS-14Submission | in November 2024“Axsome is completing preparations for the submission of the NDA for AXS-14 for the management of fibromyalgia and expects to submit the NDA to the FDA in November 2024.” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| AXS-14Submission | November 2024“AXS-14 for fibromyalgia, NDA submission (November 2024)” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
“Not compared” means ORION has not matched this wording against a complete set of SEC filings for its period. It says nothing either way about whether a matching filing exists. Wording without exact dates is not given calendar dates.
Historical summaries and source dates are retained separately from the SEC timing quotes above. Earlier publications were collected retrospectively.
Historical catalog checked .
No historical announcement trail is retained for this company in this catalog.
Original ClinicalTrials.gov record · Open the selected study
These are selected linked records and dated source metadata, not a live registry recheck or the company’s full pipeline. Company announcements and the selected registry study are separate evidence sets. No stage or event timing is borrowed between them.
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