US FDA grants Reunion Neuroscience's luvesilocin (RE104) Breakthrough Therapy Designation for postpartum depression

The U.S. Food and Drug Administration granted Breakthrough Therapy Designation to luvesilocin, formerly known as RE104, for the treatment of postpartum depression. The designation is based on positive efficacy data from the RECONNECT Phase 2 clinical trial. The study met its primary endpoint, demonstrating a statistically significant reduction in Montgomery-Asberg Depression Rating Scale total score on Day 7. Treatment delivered rapid and durable effects starting as early as Day 1 and continuing through Day 28, with 70 percent of patients receiving the 30 milligram dose in remission at both Day 7 and Day 28. Topline results were announced in August 2025, and full data were presented at the American College of Neuropsychopharmacology Annual Meeting in January 2026. The Breakthrough Therapy Designation is intended to expedite development and review of drugs for serious conditions where preliminary clinical evidence indicates substantial improvement over available therapy. It provides eligibility for Fast Track features, enhanced FDA guidance on development, and increased engagement with senior FDA leadership. Reunion Neuroscience announced the decision on February 23, 2026. The company said it is aligned with the FDA on the registrational path for luvesilocin in postpartum depression and remains on track to initiate a Phase 3 trial in 2026. Mark Pollack, chief medical officer of Reunion, said the designation underscores the urgency of the unmet need in postpartum depression and the strength of the clinical data relative to current treatment options.