- The FDA has issued a Complete Response Letter (CRL) to Axsome Therapeutics Inc's (NASDAQ:AXSM) 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.
- Related: Axsome Poised To Receive FDA Rejection For Its Migraine Candidate, Shares Fall.
- The principal reasons given in the CRL relate to chemistry, manufacturing, and controls (CMC) considerations. The CRL identified the need for additional CMC data on the drug product and manufacturing process.
- Axsome reported a Q1 FY22 cash balance of $84.7 million. It believes that its current cash and the remaining committed capital from the $300 million term loan facility are sufficient to fund anticipated operations into 2024.
- Price Action: AXSM shares closed at $31.75 on Friday.
Get all your news in one place.
100’s of premium titles.
One app.
Start reading
One app.
Get all your news in one place.
100’s of premium titles. One news app.
As Expected, FDA Rejects Axsome Therapeutics' Migraine Candidate
Sign up to read this article
Read news from 100’s of titles, curated specifically for you.
Already a member?
Sign in here
Top stories on inkl right now
One subscription that gives you access to news from hundreds of sites
Already a member?
Sign in here
Related Stories
Top stories on inkl right now
One subscription that gives you access to news from hundreds of sites
Already a member?
Sign in here
Our Picks