Axsome Stock Drops To 52-Week Low On FDA Response Letter For Depression Candidate

Wrapped up in its Q2 earnings release, Axsome Therapeutics Inc AXSM said that on July 30, it received an FDA letter for a marketing application for AXS-05 for the treatment of major depressive disorder (MDD).
The letter stated that the deficiencies preclude discussion of labeling and post-marketing requirements/commitments at this time.
The letter did not disclose the deficiencies. The FDA said that the review is ongoing. The target action date for the application is August 22.
Axsome believes that its cash of $141.2 million at June 30, along with a $225 million term loan facility, is sufficient to fund anticipated operations into at least 2024.
Separately, Axsome announced that AXS-05 met the primary endpoint by substantially and statistically significantly delaying the relapse of depressive symptoms compared to placebo.
AXS-05 significantly prevented relapse of depression over at least six months compared to placebo.
The MERIT Phase 2 trial evaluated 44 treatment-resistant depression (TRD) patients.
Price Action: AXSM shares are down 41.7% at $29.81 during the market session on the last check Monday.
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