Why Axsome Therapeutics Is Plunging Again Today
Shares of Axsome Therapeutics (NASDAQ: AXSM) are down 14% to $23.53 apiece as of 2:30 p.m. EDT after a brutal sell-off on Aug. 9 wiped out nearly 50% of its equity value. Investors are still upset that the U.S. Food and Drug Administration (FDA) outlined deficiencies in Axsome's New Drug Application filing for its central nervous system drug, AXS-05 -- which will lengthen the approval process.
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The FDA issued neither a complete response letter nor a refusal to file -- leading many shareholders to wonder if the stock is oversold in the face of a small blunder. But the setback did bring up a few issues. Axsome planned to submit its NDA filing for AXS-05 last year after the drug succeeded in a phase 3 study to treat depression, but it got delayed due to a COVID-19-related logistical delay from one vendor.
Source Fool.com
