Shares of Axsome Therapeutics (AXSM 1.11%) have sunk 19.8% as of 10:36 a.m. ET on Monday. The decline comes after the company revealed that it expects to receive a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for AXS-07 in treating migraine.
The FDA set a PDUFA date of April 30, 2022, for its review of the NDA for AXS-07. Axsome now looks for a thumbs-down by that date after the agency informed it on Friday that chemistry, manufacturing, and controls problems identified during the review of the NDA are unresolved.
Axsome seems to be taking one step forward and two steps back these days. Just last week, the company announced that it had agreed to the FDA's proposed postmarketing requirements for AXS-05 in treating major depressive disorder. This move appeared to pave the way for a likely approval from the agency.
Now, though, a rejection for AXS-07 in migraine looks inevitable. Axsome simply doesn't have enough time to resolve the problems identified by the FDA in the regulatory filing for the experimental drug.
It's not the end of the road for AXS-07 by any stretch, though. Axsome will almost certainly work as quickly as possible to correct any deficiencies in its manufacturing process for the drug and refile its NDA.
We don't know at this point what the specific problems identified by the FDA are or how long it might take for Axsome to revolve them. However, the company is scheduled to provide its first-quarter update on May 2. Investors could learn more about what's next for AXS-07 in Axsome's conference call with analysts.