Why Axsome Therapeutics Stock Is Sinking Today
Shares of Axsome Therapeutics (NASDAQ: AXSM) 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.
Source Fool.com
