The FDA moved to speed reviews for three psychedelic drug programs, issuing national priority review vouchers tied to Compass Pathways’ psilocybin treatment-resistant depression program, Usona Institute’s psilocybin-like candidate for major depressive disorder, and Transcend Therapeutics’ MDMA-like approach for post-traumatic stress disorder. The agency also confirmed its selections in connection with the voucher program under the Trump administration’s push to broaden access to mental health treatments. Compass disclosed it received a voucher, while other companies were identified by a person familiar with the matter. In a separate update, the FDA also issued commissioner vouchers focused on psychedelic development, underscoring the agency’s effort to funnel additional review incentives into the category. For developers, the vouchers can materially change development and commercial timelines by making review pathways faster and providing assets that can be monetized depending on downstream regulatory outcomes.
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