Usona Files Psilocybin NDA, Accelerating Race Against Compass Pathways
Usona Institute has submitted a New Drug Application (NDA) to the FDA for its psilocybin candidate targeting major depressive disorder. This makes it the second psychedelic application under review, following Resilient Pharmaceuticals' MDMA filing. Both Usona and competitor Compass Pathways hold Commissioner’s National Priority Vouchers, potentially leading to FDA decisions by late 2026 or early 2027. While Usona has filed, Compass plans to submit its NDA for treatment-resistant depression this quarter. The race remains close, with both companies undergoing FDA site inspections and working on risk mitigation strategies.
Key points
- Usona Institute completed its NDA submission to the FDA for psilocybin to treat major depressive disorder.
- This is the second psychedelic NDA currently under FDA review, after Resilient Pharmaceuticals refiled its MDMA application for PTSD.
- Both Usona and Compass Pathways possess Commissioner’s National Priority Vouchers, aiming for FDA decisions within two months of filing.
- Compass Pathways intends to file its NDA for treatment-resistant depression in the current quarter, with an update expected on November 3.
- FDA site inspections have occurred for both Usona and Compass, with Usona currently addressing agency questions and designing its REMS program.
Background
Previous coverage noted that psilocybin shows rapid depression relief in trials, though long-term gains may fade. The current filings represent a significant step in commercializing psychedelic therapies, moving from research to regulatory approval. The competitive landscape includes other developers like AbbVie and Otsuka, who participated in Usona’s recent 'Models of Care Summit' in Fitchburg, Wisconsin.
Why it matters
The filing accelerates the timeline for the first approved psychedelic drug in the U.S., potentially impacting treatment options for depression. The close race between nonprofit Usona and for-profit Compass Pathways highlights differing commercial strategies, including pricing, labeling, and patent protections. A decision in late 2026 or early 2027 could reshape mental health treatment standards and market dynamics.
What to watch
Compass Pathways is expected to provide an update on its NDA filing status on November 3. FDA decisions for both Usona and Compass could arrive by late 2026 or early 2027, contingent on the two-month timeline of their priority vouchers. Further developments will depend on the completion of risk evaluation and mitigation strategy (REMS) programs and final agency reviews.
- Usona Files Psilocybin for Depression NDA as Race With Compass Tightens Psychedelic Alpha
- CMPS, HELP Stocks On Track For Worst Day In Months On Competitive FDA Psychedelic Race Fears Yahoo Finance
- Press Release: Compass Pathways Announces Third Quarter 2026 Financial Results and Business Highlights Moomoo
- Form 8K COMPASS PATHWAYS PLC For: 3 November By Investing.com Investing.com UK
- 1 Reason Compass Pathways Is Worth a Second Look This Month The Motley Fool
Want the full story? Read the original reporting
Read on Psychedelic Alpha