President Trump signed an executive order directing the FDA and other federal agencies to accelerate research and improve access to psychedelic drugs for serious mental illnesses. The order instructs the FDA to provide Commissioner’s National Priority Vouchers (CNPVs) to “appropriate” psychedelic drugs that meet criteria tied to the Breakthrough Therapy designation. Market participants also focused on funding requirements that direct HHS to spend at least $50 million via ARPA-H to support and partner with state governments running programs for psychedelic development. One specific program update included COMP360 receiving a CNPV, positioning it as a likely early beneficiary of the accelerated pathway.
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