Tuesday, March 26, 2024 6:30:04 AM
NDA resubmission for AXS-07!!!
Who knows how long it will take them to give the answer on this?
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. The CRL identified the need for additional CMC data pertaining to the drug product and manufacturing process. Axsome believes that the issues raised in the CRL are addressable and intends to provide potential timing for a resubmission following consultation with the FDA.
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Recent AXSM News
- Axsome Therapeutics Recognizes May as Mental Health Awareness Month • GlobeNewswire Inc. • 05/01/2024 11:00:00 AM
- Axsome Therapeutics Highlights Innovative Neuroscience Portfolio at the American Academy of Neurology (AAN) 2024 Annual Meeting • GlobeNewswire Inc. • 04/15/2024 11:00:00 AM
- Axsome Therapeutics to Report First Quarter 2024 Financial Results on May 6 • GlobeNewswire Inc. • 04/10/2024 11:00:00 AM
- Axsome Therapeutics Initiates ENGAGE Phase 3 Trial of Solriamfetol for the Treatment of Binge Eating Disorder • GlobeNewswire Inc. • 04/01/2024 11:00:00 AM
- Axsome Therapeutics Announces Results of CRESCENDO Narcolepsy Patient Survey Demonstrating Unmet Needs in Treated Narcolepsy Type 1 Patients • GlobeNewswire Inc. • 03/25/2024 11:00:00 AM
- Axsome Therapeutics Announces AXS-12 Achieves Primary Endpoint in the SYMPHONY Phase 3 Trial in Narcolepsy • GlobeNewswire Inc. • 03/25/2024 10:30:00 AM
- Axsome Therapeutics Initiates PARADIGM Phase 3 Trial of Solriamfetol for the Treatment of Major Depressive Disorder • GlobeNewswire Inc. • 03/19/2024 11:00:00 AM
- Axsome Therapeutics to Present at the Leerink Partners Global Biopharma Conference • GlobeNewswire Inc. • 03/05/2024 12:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/29/2024 11:34:06 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/29/2024 11:25:17 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/29/2024 10:39:05 PM
- Axsome Therapeutics to Present at the TD Cowen 44th Annual Healthcare Conference • GlobeNewswire Inc. • 02/27/2024 12:00:00 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 02/23/2024 01:10:48 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/20/2024 12:05:36 PM
- Axsome Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update • GlobeNewswire Inc. • 02/20/2024 12:00:00 PM
- Market Cautiousness Ahead of Retail Giants’ Earnings; Oil Prices Dip • IH Market News • 02/20/2024 10:37:35 AM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/14/2024 08:46:49 PM
- Axsome Therapeutics to Report Fourth Quarter and Full Year 2023 Financial Results on February 20 • GlobeNewswire Inc. • 01/23/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/08/2024 12:10:07 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/04/2024 12:11:55 PM
- Axsome Therapeutics Provides Preliminary Fourth Quarter and Full Year 2023 Net Revenue and 2024 Anticipated Milestones • GlobeNewswire Inc. • 01/04/2024 12:00:00 PM
- Axsome Therapeutics Presents New Data and Post-Hoc Analyses of Auvelity® in Patients with Major Depressive Disorder at the American College of Neuropsychopharmacology (ACNP) 2023 Annual Meeting • GlobeNewswire Inc. • 12/11/2023 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/07/2023 09:05:40 PM
- Axsome Therapeutics Hosts Solriamfetol Virtual Investor Event with Expert Thought Leaders Today • GlobeNewswire Inc. • 12/07/2023 12:00:00 PM
- Axsome Therapeutics to Host Solriamfetol Virtual Investor Event on December 7 • GlobeNewswire Inc. • 11/22/2023 12:00:00 PM
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