FDA will issue Commissioner’s National Priority Vouchers to psychedelic Breakthrough Therapy drugs, including Compass Pathways’ COMP360 psilocybin program, under an April 18 presidential executive order. The directive could cut review times to 1-2 months.\n\nThat’s a meaningful shift for a class that’s had a rough few years. In August 2024, FDA rejected Lykos Therapeutics’ MDMA-assisted PTSD therapy citing selection bias. COMP360, targeting PTSD and treatment-resistant depression, was left off the initial CNPV awardees list despite being shortlisted.\n\nRBC Capital Markets called the order a “substantial step towards diminishing regulatory risk in this emerging class of therapies, enabling investor comfort,” in an April 19 note to investors.\n\nThe CNPVs at stake can compress review timelines in ways standard expedited pathways don’t fully replicate. The question is which Breakthrough Therapy-designated psychedelic programs are now positioned to collect one, and whether COMP360 gets back on the list it was already shortlisted for.\n\nThe order also raises broader questions about the CNPV program itself. Regulatory experts have already flagged concerns about a possible connection between CNPVs and Trump administration drug pricing priorities. Attaching them to psychedelics, a category with growing commercial interest, adds another layer of scrutiny to what’s supposed to be a scientific designation.\n\nCOMP360 was shortlisted before the initial list dropped. The April 18 order may change that calculus.\n\nSarah Chen