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

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🧠 Reunion Neuroscience announced it will present full data from its RECONNECT Phase 2 clinical trial at upcoming psychiatric medicine conferences.

💊 The Phase 2 trial evaluated luvesilocin, a psychedelic-inspired prodrug administered via subcutaneous injection, in adult female patients with moderate-to-severe postpartum depression.

✅ The study met its primary endpoint, demonstrating statistically significant and clinically meaningful reduction in depression scores (MADRS) on Day 7 for treated patients.

📉 Clinically meaningful reductions in depression were observed as early as the first day following administration and maintained through a 28-day follow-up period.

📊 Significant improvements were also seen in secondary endpoints, including response rates, remission rates, and other measures of postpartum depression symptoms.

🤝 Reunion Neuroscience aligned with the U.S. Food and Drug Administration (FDA) on a registrational development path for luvesilocin based on these positive results.

🚀 The company plans to advance luvesilocin into a pivotal Phase 3 trial in 2026, with expectations that success could support potential registration for postpartum depression treatment.

🎤 Mark Pollack, M.D., Chief Medical Officer of Reunion Neuroscience, will present the data at the ASCP Annual Meeting on Tuesday, May 26, 2026.

📅 The company also plans to present findings at a poster session at the American Psychiatric Association (APA) Annual Meeting in San Francisco in May 2026.

🆕 Luvesilocin was granted Breakthrough Therapy Designation by the FDA for postpartum depression following positive data from the RECONNECT trial.

🔬 Reunion is also currently enrolling patients in additional Phase 2 trials: REKINDLE for adjustment disorder and RECLAIM for generalized anxiety disorder.

💼 Luvesilocin is designed to offer rapid efficacy with a short psychoactive experience, aiming to be more convenient than longer-acting psychedelics like psilocybin or LSD.

🧬 Reunion Neuroscience also advanced a non-psychedelic lead candidate, RE245, from its discovery program and plans to file an Investigational New Drug (IND) for it in 2026.

⚠️ This clinical stage biopharmaceutical company focuses on addressing underserved mental health disorders where standard of care options are limited.

Bullish Signals
  • Reunion Neuroscience successfully met the primary endpoint of the RECONNECT Phase 2 trial, demonstrating a statistically significant and clinically meaningful reduction in depression for patients with postpartum depression as measured by the MADRS total score.
  • The drug showed rapid efficacy with clinically meaningful reductions observed on the first day following administration, a distinct advantage over longer psychedelic experiences like psilocybin or LSD that require extended monitoring.
  • Based on these robust data, Reunion aligned with the FDA to advance luvesilocin into a pivotal Phase 3 trial in 2026, a strategic step toward potential registration for treating postpartum depression.
  • The company has already secured Breakthrough Therapy Designation from the FDA for luvesilocin in PPD following positive Phase 2 results, validating the strong regulatory pathway forward.
  • Reunion is actively enrolling patients in multiple concurrent Phase 2 trials, including REKINDLE for adjustment disorder (NCT07002034) and RECLAIM for generalized anxiety disorder (NCT07489651), indicating broad pipeline development beyond PPD.
  • The lead candidate luvesilocin is a patented prodrug designed for convenient subcutaneous administration, offering a novel delivery method for next-generation psychedelic-inspired therapeutic solutions.
  • In addition to its psychedelic program, Reunion has advanced a non-psychedelic discovery program with lead candidate RE245 and plans to file an IND in 2026, diversifying its pipeline opportunities.
Risk Factors
  • Reunion Neuroscience is a clinical-stage biopharmaceutical company, indicating it has not yet achieved any approved products or generated revenue from its pipeline.
  • The Phase 2 trial results were previously only presented as a poster session at the ACNP Annual Meeting before being fully detailed later, which could raise questions about transparency or timing of data disclosure.
  • Registration of luvesilocin in PPD will require a successful pivotal Phase 3 trial in 2026, and the company explicitly states that if this trial is not successful, registration may not be achieved.
  • Reunion has multiple ongoing clinical trials (REKINDLE for AjD and RECLAIM for GAD), increasing operational risk if patient recruitment or data generation faces challenges in any of them.
  • The company plans to file an IND for its non-psychedelic candidate RE245 in 2026, but the timeline and likelihood of regulatory approval are uncertain at this stage.
  • The drug is administered via subcutaneous injection and requires monitoring during administration due to psychoactive effects, which could limit patient convenience compared to oral alternatives.
Full Analysis
Reunion Neuroscience is scheduled to present full data from its Phase 2 RECONNECT trial at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting on May 26, 2026, in Miami, Florida, and at the American Psychiatric Association (APA) Annual Meeting in San Francisco in May 2026. The trial evaluated luvesilocin, a proprietary subcutaneous prodrug of 4-OH-DiPT, specifically for treating moderate-to-severe postpartum depression (PPD) in adult female patients. The company reported that the RECONNECT trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) total score by Day 7. Clinically meaningful reductions were observed for patients treated with the 30mg dose of luvesilocin starting on the first day following administration and were maintained through a 28-day follow-up period. Additionally, substantial improvements in secondary endpoints, including MADRS response and remission rates, as well as other measures of PPD-related symptoms, were noted. Following these positive results, Reunion Neuroscience has aligned with the U.S. Food and Drug Administration (FDA) on a path for registrational development and received Breakthrough Therapy Designation for luvesilocin in PPD. The company expects to advance into a pivotal Phase 3 trial in 2026; if successful, a single Phase 3 trial could complete the data package required for potential registration. The lead drug candidate is designed for rapid efficacy with a short psychoactive experience to improve convenience over longer-acting agents like psilocybin or LSD. Reunion is concurrently evaluating luvesilocin for other indications including adjustment disorder, generalized anxiety disorder, and other mood disorders, with ongoing Phase 2 trials REKINDLE for adjustment disorder and RECLAIM for GAD. The company also has a non-psychedelic candidate, RE245, in its pipeline with an Investigational New Drug (IND) filing planned for 2026.