Axsome expects migraine drug to be rejected as manufacturing issues arise
A New York-based biopharma company now expects a rejection from the FDA for its potential migraine drug as it’s facing manufacturing questions.
Axsome Therapeutics, according to an SEC filing on Monday, was informed by the FDA that chemistry, manufacturing and controls (CMC) issues were identified during the FDA’s review of NDA for its migraine candidate known as AXS-07, setting up the anticipated CRL.
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