Axsome Stock Drops To 52-Week Low On FDA Response Letter For Depression Candidate
- Wrapped up in its Q2 earnings release, Axsome Therapeutics Inc (NASDAQ: 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.
- Related content: Benzinga's Full FDA Calendar.
© 2025 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Posted-In: Biotech Earnings News Guidance Short Ideas Health Care Small Cap FDA
