Trump signed an executive order Saturday directing FDA to issue Commissioner’s National Priority Vouchers (CNPVs) to psychedelic drugs with breakthrough therapy designation, potentially compressing review timelines from 6-12 months to 1-2 months.
The order lands after months of building investor skepticism about the regulatory pathway for these therapies, according to RBC Capital Markets. In August 2024, FDA rejected Lykos Therapeutics’ MDMA-assisted therapy for PTSD, citing selection bias and functional unblinding in its clinical trial. When the complete response letter was published in mid-2025, Lykos founder Rick Doblin called the verdict inconsistent, claiming the FDA moved the goalposts after the company addressed its concerns. The biotech has since rebranded as Resilient Pharmaceuticals.
Earlier this year, Compass Pathways’ psilocybin therapy COMP360 was reportedly in the running for a CNPV but didn’t make the cut. COMP360 holds FDA breakthrough therapy designation for PTSD and treatment-resistant depression. Jefferies says a potential 2027 approval would mark the first FDA-approved psychedelic. Compass shares jumped 25% to $8.33 before Monday’s opening bell. Definium Therapeutics, which holds breakthrough designation for DT120 in generalized anxiety disorder, gained roughly 13% to $25.73.
The EO doesn’t change what FDA requires in a clinical dossier. CNPVs shorten the review queue for drugs that already cleared the breakthrough hurdle; FDA’s standards stay put.
A 2027 COMP360 approval would place the first FDA-approved psychedelic on the market.
— Sarah Chen