U.S. FDA Grants Reunion Neuroscience’s Luvesilocin (RE104) Breakthrough Therapy Designation Status
MORRISTOWN, New Jersey, February 23, 2026 – Reunion Neuroscience, Inc., a clinical-stage biopharmaceutical company committed to revolutionizing the treatment of underserved mental health disorders through the advancement of next-generation psychedelic-inspired therapeutic solutions, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to luvesilocin (formerly RE104) for the treatment of postpartum depression (PPD).
