FDA is directed to grant Commissioner’s National Priority Vouchers to breakthrough-designated psychedelic drugs under an executive order Trump signed Saturday, a move that could cut review timelines from 6-12 months to 1-2 months.
The order arrives after a rough run for the space. FDA rejected Lykos Therapeutics’ MDMA-assisted therapy for PTSD in August 2024, citing selection bias and functional unblinding in its clinical trial. Founder Rick Doblin called it inconsistent: “There is a changing of the goal post,” he said in September 2025, claiming FDA didn’t consider the biotech’s responses to its concerns. The company has since rebranded as Resilient Pharmaceuticals.
Earlier this year, reports emerged that Compass Pathways’ psilocybin therapy COMP360 had been in the running for a CNPV but was left out. COMP360 carries breakthrough designation and is under review for PTSD and treatment-resistant depression. Jefferies expects a potential go-ahead in 2027, which would mark the first FDA-approved psychedelic.
Markets didn’t wait. 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 around 13% to $25.73.
RBC Capital Markets told investors the EO is “a substantial step towards diminishing regulatory risk in this emerging class of therapies, enabling investor comfort.” Jefferies called it an “official stamp of validation” — confirmation that government support is “real/actionable.”
Sarah Chen