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

Reunion Neuroscience — Privately held Reunion Neuroscience said the FDA granted Breakthrough Therapy Designation to luvesilocin (formerly RE104), a subcutaneous prodrug of the psilocybin-like compound 4-OH-DiPT, for postpartum depression.

The designation followed Phase 2 RECONNECT data in which 70% of patients on the 30 mg dose reached remission by Day 7, sustained through Day 28. Reunion expects to begin a pivotal Phase 3 PPD trial in 2026, adding another psychedelic-derived asset to the FDA's expedited-review roster.

Source: globenewswire.com

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