Psychedelic drug developers fall after Usona submits depressive drug application
CMPS•Shares of Compass Pathways fell 29% after Usona Institute submitted a marketing application for psilocybin to treat major depressive disorder. Jefferies said approval could come in late 2026 or early 2027, while shares of Definium Therapeutics, Helus Pharma and GH Research also declined.
1. Shares slide after filing
Compass Pathways shares fell 29% to $8.22 in afternoon trading after Usona Institute submitted a marketing application for psilocybin in major depressive disorder. Jefferies said the filing could support approval in late 2026 or early 2027 and position Usona as the first to win approval for a psychedelic therapy.
2. Review and competition
Jefferies said Usona and Compass Pathways’ COMP360 are eligible for expedited review under the CNPV program, putting the two psilocybin therapies on similar review timelines. It said Usona’s application may raise questions about first-mover advantages in pricing and regulation, while listed peers have stronger clinical datasets and greater commercial resources. Usona’s plans to commercialize the treatment remain unclear; Jefferies said Compass would protect its intellectual property “aggressively” even if Usona launches.
3. Other developers fall
Definium Therapeutics shares fell 10.5%, Helus Pharma shares fell 17% and GH Research shares fell 1.8%. Jefferies saw limited impact on Definium and Helus because their programs use different psychedelic compounds.
