Articles from Reunion Neuroscience Inc.

-- Breakthrough Therapy Designation Based on Positive RECONNECT Phase 2 Clinical Data ---- Aligned with U.S. Food and Drug Administration on Registrational Path for Luvesilocin in Postpartum Depression (PPD); On Track to Initiate Phase 3 Trial in 2026 -- 

MORRISTOWN, N.J., Feb. 19, 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 its participation in the following upcoming conferences:

-- Met Primary Endpoint with 30mg Dose of RE104 with 23.0-Point Total Score Reduction in Montgomery-Åsberg Depression Rating Scale (MADRS) on Day 7 (p=0.0094) ---- 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 ---- Aligned with U.S. Food and Drug Administration (FDA) on Registrational Path for RE104 in PPD; On Track to Initiate Phase 3 Trial in 2026 --

-- Aligned with U.S. Food and Drug Administration (FDA) on Registrational Path for RE104 in Postpartum Depression (PPD); On Track to Initiate Phase 3 Trial in 2026 -- -- Enrolling Phase 2 REKINDLE Trial of RE104 in Adjustment Disorder (AjD); Initial Data Expected in 1Q 2027 ---- On Track to Initiate Phase 2 RECLAIM Trial in Generalized Anxiety Disorder (GAD) in 1Q 2026 --

-- AjD Represents an Area of Significant Unmet Need; No U.S. Food and Drug Administration (FDA)-Approved Therapies Available --

-- Upsized Series A Financing Brings Total Amount Raised to $133 Million --

-- Achieved Primary Endpoint with 30mg Dose of RE104 Demonstrating 23.0-Point Reduction from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Score on Day 7, a 5.8-Point Greater Reduction Than Patients Treated with 1.5mg Dose (p=0.0094) --

-- Phase 1 Data Highlight RE104 Favorable Safety Profile and Short Duration Psychoactive Experience --

-- Enrollment Completed on Schedule; Topline Results Expected Q3 2025 --

-- AjD is a Mental Health Condition Triggered By a Stressful Life Event; Particularly Common in People with Serious Medical Illness --

Reunion to Participate in the ‘New Treatment Options Panel’ Discussion at the 2025 Maternal Mental Health FORUM on March 18 at 2:30 p.m. ET

Patient Enrollment Ongoing in Phase 2 RECONNECT Trial of RE104 in Postpartum Depression (PPD); Topline Data Anticipated Mid-2025

MORRISTOWN, N.J., Dec. 11, 2024 (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 therapeutic solutions, presented a poster detailing RE104 Phase 1 data at the American College of Neuropsychopharmacology (ACNP) 63rd Annual Meeting in Phoenix, Arizona.

Reunion to Sponsor Scholarships that will Train Healthcare Professionals on Maternal Mental Health Disorders, including Postpartum Depression

MORRISTOWN, N.J., Sept. 10, 2024 (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 therapeutic solutions, today announced the appointment of Mark Pollack, M.D., as Chief Medical Officer. Dr. Pollack previously served as a member of Reunion’s Advisory Board and is a highly accomplished psychiatrist with decades of leadership experience in neuroscience-focused drug development and clinical research. Pollack replaces Dr. Robert Alexander who will continue to remain involved with Reunion as a strategic advisor.

Initiative Coincides with Start of Reunion’s Phase 2 RECONNECT Study in Postpartum Depression

MORRISTOWN, N.J., July 23, 2024 (GLOBE NEWSWIRE) -- Reunion Neuroscience Inc., a clinical-stage biopharmaceutical company committed to pushing the boundaries of neuroscience, today announced that the first patient has been dosed in the RECONNECT Phase 2 clinical trial of RE104 for the treatment of postpartum depression (PPD). RE104 was designed to be a safe, fast-acting, single-dose therapy to benefit patients suffering from underserved mental health disorders, including PPD.

MORRISTOWN, N.J., May 20, 2024 (GLOBE NEWSWIRE) -- Reunion Neuroscience Inc., a clinical-stage biopharmaceutical company committed to pushing the boundaries of neuroscience, today announced the publication of the results of preclinical studies in ACS Chemical Neuroscience that validate the decisions to pursue RE104, a proprietary, patented prodrug of 4-OH-DiPT as a potential therapeutic in depressive disorders. The paper, titled “RE104: Synthesis and Activity of a Novel Serotonergic Psychedelic Prodrug of 4-Hydroxy-N,N-diisopropyltryptamine,” was co-authored by Robert Alexander, Ph.D., Reunion’s Chief Medical Officer, and Michael D. Ehlers, M.D., Ph.D., Chief Scientific Officer and Venture Partner at Apple Tree Partners, with Nathan Bryson, Ph.D., Reunion’s Chief Scientific Officer, as senior author.

MORRISTOWN, N.J., April 03, 2024 (GLOBE NEWSWIRE) -- Reunion Neuroscience Inc., a venture backed clinical-stage biopharmaceutical company committed to pushing the boundaries of neuroscience, today announced that the clinical dataset from the Company’s Phase 1 study of its lead asset, RE104, will be presented in both a podium and poster at the Anxiety and Depression Association of America (ADAA) Conference taking place April 11-14, 2024, in Boston, MA. The presentations will highlight the Phase 1 findings on RE104, a proprietary, potential best-in-class, patented prodrug of 4-OH-DiPT, a psilocybin-like compound. In a Phase 1 study, RE104 produced a psychedelic, psychoactive state similar in intensity and quality to psilocybin, but lasting only about half the time (3-4 hours) while demonstrating a similar, favorable safety profile. Reunion is evaluating RE104 in patients with underserved mental health disorders, beginning with postpartum depression (NCT06342310).