Axsome Therapeutics plans to submit a New Drug Application (NDA) to the FDA. Herriot Tabuteau is the CEO of the company.
6 reports, 2 independent
Updated Aug 10
Gone quiet
- Reports
- 6
- Developments
- 2
- Repetition
- 67%
New informationRepeats or wire copies
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What happened
Axsome Therapeutics plans to submit a New Drug Application (NDA) to the FDA. Herriot Tabuteau is the CEO of the company.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.Axsome Therapeutics plans NDA submissions to the FDA.1 source
- FDA rejected Axsome's NDA submission, requiring further study.
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The entities involved
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Axsome Therapeutics
American biopharmaceutical company
Nothing else this week.
- FDA
Related events
- Data was presented in Athens supporting a future U.S. NDA submission to the FDA.
- Iovance Biotherapeutics received FDA approval for its therapy, and the company is listed on Nasdaq.
- Amylyx Pharmaceuticals is seeking FDA approval for a new drug treatment.
- A clinical study led by Dr. Swee Lay Thein is underway at the National Institutes of Health and is subject to oversight by the Food and Drug Administration.
- Cogent Biosciences plans to submit an NDA to the FDA, with Andrew Robbins as President and CEO.
Coverage
Newest first; wire copies grouped- yahoo.com
- GlobeNewswireAxsome Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update Total 2Q 2025 net product revenue of $150.0 million, representing growth of 72% year-over-year and 24% s
- GlobeNewswireAxsome Therapeutics to Ring the NASDAQ Stock Market Opening Bell Today NEW YORK, July 21, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new
- Unknown outlet