Posted by Michael Wonder on 23 Feb 2026
US FDA grants Reunion Neuroscience’s luvesilocin (RE104) breakthrough therapy designation status
23 February 2026 - Reunion Neuroscience today announced that the US FDA has granted breakthrough therapy designation to luvesilocin (formerly RE104) for the treatment of postpartum depression.
Breakthrough therapy designation for luvesilocin is supported by strong positive efficacy data from the RECONNECT Phase 2 clinical trial.
