Reunion Neuroscience to Present Full Data from RECONNECT Phase 2 Clinical Trial at Upcoming ASCP and APA Annual Meetings

MORRISTOWN, N.J., May 11, 2026 (GLOBE NEWSWIRE) -- 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 it will share the full results of the RECONNECT, a Phase 2 trial evaluating luvesilocin in adult female patients with moderate-to-severe postpartum depression (PPD), in an oral presentation at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting 2026 – Psychiatry and AI: Promises, Perils, and Pathways Forward in Miami, FL.

As previously presented in a poster session at the American College of Neuropsychopharmacology (ACNP) Annual Meeting, RECONNECT met its primary endpoint, with a statistically significant and clinically meaningful reduction in depression as measured by the MADRS total score observed on Day 7. Clinically meaningful reductions in MADRS were observed for luvesilocin 30mg-treated patients on the first day following administration and maintained through the 28-day follow-up. Substantial and clinically meaningful improvements in other key secondary endpoints, including MADRS response and remission rates and other measures of PPD-related symptoms, were also observed.

Based on these data, Reunion Neuroscience aligned with the U.S. Food and Drug Administration (FDA) on a registrational path for luvesilocin in PPD. The Company expects to advance luvesilocin into a pivotal Phase 3 trial in 2026. Based on feedback from the FDA, Reunion expects that the results from this single Phase 3 trial, if successful, would complete the data package required to support potential registration of luvesilocin in PPD.

Details of the ASCP presentation are as follows:

Title: RE104: A Novel Serotonergic Psychedelic 4-OH-DiPT Prodrug for the Treatment of Postpartum Depression 
Session: Pharmaceutical Pipeline Session
Session Date and Time: Tuesday, May 26, 2026 from 2:00 – 4:00 PM ET
Presentation Time: Tuesday, May 26, 2026 from 2:00 – 2:10 PM ET
Presenter: Mark Pollack, M.D., Chief Medical Officer, Reunion Neuroscience

Reunion Neuroscience will also present data in a poster session entitled, “RE104: A Novel Psychedelic Agent for Postpartum Depression,” at the 2026 American Psychiatric Association (APA) Annual Meeting, May 18, 2026 in San Francisco, CA.

About Luvesilocin
Luvesilocin is a proprietary, potential best-in-class, patented prodrug of 4-OH-DiPT, which is administered via a subcutaneous injection. Reunion designed luvesilocin to deliver rapid efficacy with a short psychoactive experience, making luvesilocin more convenient than the longer experience and monitoring required with psychedelics like psilocybin or LSD.

Reunion is evaluating luvesilocin as a subcutaneous administration for the treatment of mood and anxiety disorders, including PPD, adjustment disorder (AjD), generalized anxiety disorder (GAD) and other potential indications. Following positive data from the Phase 2 RECONNECT trial, the U.S. Food and Drug Administration granted luvesilocin Breakthrough Therapy Designation in PPD. Reunion expects to initiate a pivotal Phase 3 clinical trial in PPD in 2026, which, if successful, could support potential registration of luvesilocin. Additionally, Reunion is enrolling patients in the Phase 2 REKINDLE (NCT07002034) clinical trial in patients with AjD related to cancer and other medical illnesses and the Phase 2 RECLAIM (NCT07489651) clinical trial in patients with GAD.

About Reunion Neuroscience, Inc.
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. Reunion is actively investigating the use of its lead product candidate, luvesilocin, in postpartum depression, adjustment disorder and generalized anxiety disorder and may in the future expand to additional neuropsychiatric indications where there remains a significant unmet need that is not addressed by the current standard of care. Reunion has advanced a lead candidate, RE245, from its non-psychedelic discovery program and plans to file an IND in 2026. To learn more, visit https://reunionneuro.com, and follow Reunion on LinkedIn and Bluesky.

For further information:
IR Inquiries:
Hannah Deresiewicz
Precision AQ
hannah.deresiewicz@precisionaq.com

PR Inquiries:
Ashley Murphy
Precision AQ
ashley.murphy@precisionaq.com

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