Drugs / AXS-07
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | migraine disorder | 2024-08-05 | “the resubmission of the Company’s New Drug Application (NDA) for AXS-07 for the acute treatment of migraine” gcs-web.com ↗ “The Company has resubmitted its New Drug Application (NDA) for AXS-07 for the acute treatment of migraine.” gcs-web.com ↗ “Axsome submitted an NDA for AXS-07 for the acute treatment of migraine in the second quarter.” gcs-web.com ↗ “NDA resubmission for AXS-07 for the treatment of migraine accepted by the FDA” gcs-web.com ↗ |
| Rejected (CRL) | US (FDA) | — | migraine disorder | 2022-05-02 | “received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for AXS-07” gcs-web.com ↗ “FDA in the complete response letter may impact the potential approvability of the Company’s NDA for AXS-07 for the acute treatment of migraine” gcs-web.com ↗ “complete response letter may impact the potential approvability of the Company’s NDA for AXS-07 for the acute treatment of migraine” gcs-web.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT03896009 | Mar → Dec 2019 | migraine disorder | Axsome Therapeutics, Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2025-02-24 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces SYMBRAVO® (meloxicam and rizatriptan) Achieves Primary Endpoint in the EMERGE Phase 3 Trial in Migraine Patients Experiencing Inadequate Response to Oral CGRP Inhibitors gcs-web.com ↗
SYMBRAVO demonstrated statistically significantly greater migraine treatment response compared to prior treatment with an oral CGRP inhibitor (p<0.001, mTOQ-4 total score, primary endpoint) |
| 2024-11-12 | Axsome Therapeutics, Inc. | Regulatory Axsome Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update gcs-web.com ↗
NDA resubmission for AXS-07 for the treatment of migraine accepted by the FDA with PDUFA goal date of January 31, 2025 |
| 2024-09-04 | Axsome Therapeutics, Inc. | Regulatory Axsome Therapeutics Announces FDA Acceptance of NDA Resubmission for AXS-07 for the Acute Treatment of Migraine gcs-web.com ↗ |
| 2024-04-15 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Highlights Innovative Neuroscience Portfolio at the American Academy of Neurology (AAN) 2024 Annual Meeting gcs-web.com ↗
Presentations related to the AXS-07 clinical program in migraine include new pooled efficacy data from the MOMENTUM and INTERCEPT Phase 3 trials. |
| 2022-05-02 | Axsome Therapeutics, Inc. | Regulatory Axsome Therapeutics Receives FDA Complete Response Letter for New Drug Application for AXS-07 for the Acute Treatment of Migraine gcs-web.com ↗
Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for AXS-07 for the acute treatment of migraine. |
| 2021-09-14 | Axsome Therapeutics, Inc. | Regulatory Axsome Therapeutics Announces FDA Acceptance of New Drug Application for AXS-07 for the Acute Treatment of Migraine gcs-web.com ↗
Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that 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, and has set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2022 for the NDA. |
| 2020-12-31 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces Positive Efficacy and Safety Results from the Phase 3 MOVEMENT Long-Term Trial of AXS-07 in the Acute Treatment of Migraine gcs-web.com ↗
Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced positive results from the long-term, open-label Phase 3 MOVEMENT trial of AXS-07, Axsome’s novel, oral, multi-mechanistic investigational medicine in the acute treatment of migraine. |
| 2020-09-24 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Presents New Data from MOMENTUM Phase 3 Trial with AXS-07 Demonstrating Rapid Onset of Action and Reduced Symptom Recurrence in the Acute Treatment of Migraine gcs-web.com ↗
Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that AXS-07, the Company’s novel, oral, multi-mechanistic investigational medicine for the acute treatment of migraine, rapidly relieved and substantially reduced relapse of migraine pain, as compared to the potent active comparator rizatriptan, in the MOMENTUM Phase 3 trial. |
| 2020-04-06 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces AXS-07 Achieves Both Co-Primary Endpoints and Prevents Migraine Pain Progression in the INTERCEPT Phase 3 Trial in the Early Treatment of Migraine gcs-web.com ↗
In the trial, AXS-07 met the co-primary endpoints of freedom from migraine pain and freedom from most bothersome symptoms as compared to placebo. |
| 2019-12-30 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces AXS-07 Achieves Co-Primary and Key Secondary Endpoints in MOMENTUM Phase 3 Migraine Trial in Patients with History of Inadequate Response gcs-web.com ↗
AXS-07 also met the key secondary endpoint, demonstrating statistically significant superiority to the active comparator rizatriptan on sustained freedom from migraine pain. |
| 2019-09-05 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Presents Positive AXS-07 Phase 1 Trial Results at the 19th Congress of the International Headache Society gcs-web.com ↗
Results of the Phase 1 trial demonstrated that AXS-07 is rapidly absorbed after oral administration, with the MoSEIC meloxicam component also displaying an extended plasma half-life, suggesting the potential for enhanced and sustained efficacy. |
| 2019-02-06 | Axsome Therapeutics, Inc. | Regulatory Axsome Therapeutics Receives FDA Agreement under Special Protocol Assessment (SPA) for the MOMENTUM Phase 3 Trial of AXS-07 in Migraine gcs-web.com ↗
The SPA provides agreement that the MOMENTUM trial design adequately addresses objectives that, if met, will support the regulatory submission for approval of AXS-07 for the indication of acute treatment of migraine in adults with or without aura. |
All press releases naming this drug 23 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AXS-07 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03896009 ↗ |
| Route | Oral | “AXS-07 is an oral, investigational medicine” NCT03896009 ↗ |