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.
The exact nature of the CMC issues is currently unknown, but the company’s stock price fell by about 20% early Monday.
Investment analysts at William Blair expect the AXS-07 NDA to be delayed by about a year, with six months to correct the issues and six months for FDA to re-review.
“On our call, management indicated that the CMC issues with AXS-07 in migraine were mutually exclusive of those that have been addressed for AXS-05 in depression,” the investor note says. “We expect additional details in the coming days once the company has received formal action from the FDA, potentially on the company’s first-quarter earnings call scheduled for May 2.”
William Blair also noted that these issues are exclusive to AXS-07, and have no link to any other products in development at Axsome.
“In the meantime, movement continues on the AXS-05 review, with management expecting a regulatory decision this quarter, and we believe the agreement on post-marketing requirements is a positive,” the Blair analysts wrote.
Back in 2020, after clearing a late-stage study, Axsome’s AXS-05 faced several challenges. The drug, which is meant to treat major depressive disorder, had then failed to meet its main goal for the AXS-05 pill, delaying any further action.
In 2021, the FDA explained its concerns with AXS-05 in a letter, outlining how FDA had identified deficiencies that preclude labeling discussions with Axsome.
However, last week, AXS-05 appeared to be back on the cusp of approval again.