MORRISTOWN, N.J. — January 20, 2026 — Leads & Copy — Reunion Neuroscience, Inc. announced the full results of RECONNECT, a Phase 2 clinical trial evaluating RE104 in adult female patients with moderate-to-severe postpartum depression (PPD). The data, which demonstrated that RE104 met its primary endpoint, were presented at the American College of Neuropsychopharmacology (ACNP) Annual Meeting.
The trial showed a statistically significant and clinically meaningful reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score on Day 7 (p=0.0094) with the 30mg dose of RE104. The study also demonstrated rapid and durable efficacy starting as early as Day 1 and continuing through Day 28, with substantial and clinically significant improvements across key measures of mood and anxiety.
Reunion Neuroscience recently completed an End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) and expects to advance RE104 into a pivotal Phase 3 trial in 2026. Based on feedback from the FDA, Reunion anticipates that the results from a single Phase 3 trial, if successful, would complete the data package required to support potential registration of RE104.
According to Mark Pollack, M.D., Chief Medical Officer of Reunion, the data underscore RE104’s potential as a new standard-of-care for PPD. He noted that the data demonstrate the rapid and durable impact of RE104 across a range of physician- and patient-reported outcomes and measures of depression, anxiety, and well-being.
The RECONNECT trial (NCT06342310) was a multi-center, randomized, double-blind, parallel-group, active dose-controlled clinical trial designed to evaluate the safety and efficacy of a single 30mg subcutaneous dose of RE104. The trial enrolled 84 adult female patients with moderate-to-severe PPD, randomized to receive RE104 30mg or a subperceptual dose of 1.5mg.
Patients in the 30mg group presented with an average MADRS total score of 33.4 and 7.64 months duration of disease, while patients in the 1.5mg group presented with an average MADRS score of 33.2 and 7.02 months duration of disease. More patients in the 30mg group were on concurrent treatment (SSRI, therapy or both) at baseline (31.7% versus 14.0%).
Key secondary endpoints included the change in MADRS at other timepoints, response rates (≥ 50% MADRS reduction), remission rates (MADRS ≤ 10), change in Hamilton Anxiety Rating Scale (HAM-A), Clinical Global Impression – Improvement (CGI-I), and Barkin Index of Maternal Function (BIMF), as well as overall safety and tolerability.
Reunion plans to initiate a pivotal Phase 3 trial of RE104 for the treatment of PPD in 2026. The company is also enrolling patients in the Phase 2 REKINDLE (NCT07002034) clinical trial in patients with adjustment disorder related to cancer and other medical illnesses, and plans to commence the Phase 2 RECLAIM clinical trial in generalized anxiety disorder in the first quarter of 2026.
RE104 is a proprietary prodrug of 4-OH-DiPT, administered via a single subcutaneous injection, designed to deliver a short, acute psychoactive experience compared to longer experience duration with psychedelics like psilocybin or LSD.
Reunion Neuroscience is focused on revolutionizing the treatment of underserved mental health disorders through the advancement of next-generation psychedelic-inspired therapeutic solutions. They are investigating the use of RE104 in postpartum depression, adjustment disorder and generalized anxiety disorder and may expand to additional neuropsychiatric indications. Reunion has advanced a lead candidate, RE245, from its non-psychedelic discovery program and plans to file an IND in 2026.
Contact:
Hannah Deresiewicz
Precision AQ
hannah.deresiewicz@precisionaq.com
Ashley Murphy
Precision AQ
ashley.murphy@precisionaq.com
Source: Reunion Neuroscience
