Shares of Axsome Therapeutics (AXSM 2.51%) were rising 6.8% as of 12:05 p.m. EST on Monday. The gain came after the company provided its third-quarter update earlier in the morning.
Axsome posted a net loss of $34.9 million, or $0.93 per share, in the third quarter. That was a little better than the average analysts' estimate of a net loss of $0.95 per share. The company didn't generate any revenue in the quarter.
While this bottom-line result was better than expected, the biotech stock probably enjoyed an even bigger boost from Axsome's encouraging pipeline update. In particular, the company stated that it thinks the deficiencies identified by the U.S. Food and Drug Administration (FDA) in the regulatory filing for AXS-05 in treating major depressive disorder (MDD) are addressable.
The FDA was originally scheduled to make an approval decision on AXS-05 in treating MDD by Aug. 22. However, it informed Axsome on Aug. 20 that its review would not be completed by that date. The FDA recently told Axsome that there were two deficiencies related to analytical methods in the Chemistry, Manufacturing, and Controls section of the New Drug Application for AXS-05.
Axsome could have another key catalyst on the way. The FDA set a Prescription Drug User Fee Act (PDUFA) date of April 30, 2022, for its review of AXS-07 in treating migraine. However, the agency told Axsome that date could slip if it can't complete an inspection of a contract manufacturing facility due to COVID-19-related travel restrictions.