Compass Pathways announced positive Phase 3 data for COMP360 psilocybin therapy in treatment-resistant depression, showing statistically significant improvements in depression scores and durability through 26 weeks, with plans to file for FDA approval in Q4 2026.
COMPASS Pathways announced positive Phase 3 results for COMP360 psilocybin in treatment-resistant depression, showing statistically significant improvements across two pivotal trials with durability signals through 26 weeks and a generally well-tolerated safety profile.
Palvella Therapeutics announced positive topline results from its Phase 3 SELVA study of QTORIN 3.9% rapamycin for microcystic lymphatic malformations, meeting all primary and secondary endpoints with strong tolerability. The company plans an NDA submission in H2 2026.