Reunion Neuroscience receives FDA Breakthrough Therapy Designation for luvesilocin
The designation for postpartum depression is based on positive Phase 2 RECONNECT data, and the company plans to start a Phase 3 trial in 2026.
Latest Reunion Neuroscience News & Updates
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Clinical-stage biopharmaceutical company developing mental health therapeutics
reunionneuro.com- Company type
- Public company
- Number of employees
- 10–30
- Industry
- Pharmaceuticals
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Latest news about Reunion Neuroscience (Reunion)
In short: Reunion reported positive Phase 2 postpartum depression results and received FDA Breakthrough Therapy designation for luvesilocin.
Company announcements
Reunion Neuroscience reports positive Phase 2 results for RE104
The 30mg dose met the primary endpoint with a 23.0-point MADRS reduction at Day 7 and durable benefit through Day 28; Phase 3 is planned for 2026.
Reunion Neuroscience closes $133 million Series A financing
The final tranche increased from $21 to $51 million, and it plans a Phase 2 GAD trial of RE104 in 1Q 2026.
Reunion Neuroscience reports positive Phase 2 results for RE104
The 30mg dose met the primary endpoint, reducing MADRS scores by 23.0 points at Day 7 versus 17.2 for the 1.5mg control.
Media coverage
U.S. FDA Grants Reunion Neuroscience’s Luvesilocin (RE104) Breakthrough Therapy Designation Status
Reunion Neuroscience is 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.
U.S. FDA Grants Reunion Neuroscience’s Luvesilocin (RE104) Breakthrough Therapy Designation Status
MORRISTOWN, N.J., Feb. 23, 2026 (GLOBE NEWSWIRE) -- Reunion Neuroscience, Inc., a clinical-stage biopharmaceutical company committed to revolutionizing the treatment of underserved mental health ...
Reunion’s psychedelic drug headed to late-stage testing
The drug, which functions similar to psilocybin, scored positive enough results in a mid-stage study...
Reunion's psychedelic prodrug reduces postpartum depression symptoms in phase 2 study
Key secondary endpoints, such a self-reporting measure of overall maternal functioning, were also supportive of Reunion Neuroscience's primary endpoint win. (iStock / Getty Images Plus...
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