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: Oppenheimer 36th Annual Healthcare Life Sciences Conference, February 25-26, 2026 (Virtual)Presentation: Thursday, February 26th at 12:40 p.m. ET T ...

Core Insights - Reunion Neuroscience, Inc. announced positive topline results from its RECONNECT Phase 2 clinical trial for RE104, demonstrating a significant reduction in postpartum depression (PPD) symptoms [1][3][8] - The company plans to initiate a pivotal Phase 3 trial for RE104 in PPD in 2026, following the promising results from the Phase 2 trial [1][9][10] Clinical Trial Results - RECONNECT trial met its primary endpoint with a 30mg dose of RE104 showing a 23.0-point reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) score on Day 7, compared to a 17.2-point reduction in the control group [1][11] - 77.1% of patients treated with RE104 30mg showed a response to therapy at Day 7, while 71.4% were in remission, significantly higher than the control group [2][3] - Clinically meaningful reductions in MADRS were observed from Day 1 and maintained through Day 28 follow-up [1][2] Safety and Tolerability - RE104 was generally well-tolerated, with no serious adverse events reported; 92.7% of patients were ready for discharge within four hours post-administration [4][6] - Common treatment-emergent adverse events included nausea (43.9%) and headache (34.1%), which were mild to moderate and resolved spontaneously [5][6] Lactation Study Insights - Preliminary data from a lactation study indicated that the amount of RE104 metabolites in breastmilk was less than 0.1% of the administered dose, suggesting minimal risk for breastfeeding mothers [7][4] Future Development Plans - The company is also evaluating RE104 for adjustment disorder (AjD) related to cancer and other medical illnesses, with plans to initiate the REKINDLE Phase 2 trial in Q3 2025 [8][10] - Reunion aims to address a range of underserved mental health conditions with RE104, potentially redefining the standard of care for PPD and AjD [8][15]

Core Insights - Reunion Neuroscience Inc. announced the publication of Phase 1 study results for RE104, highlighting its favorable safety profile and short duration psychoactive experience [1][3] - The company is currently conducting the RECONNECT Phase 2 trial for RE104 in postpartum depression, with topline results expected in Q3 2025 [1][2] Group 1: Phase 1 Study Findings - The Phase 1 study involved administering a single subcutaneous dose of RE104 ranging from 5mg to 40mg to healthy adult volunteers, with psychoactive effects lasting 3-4 hours for doses above 5mg [2][6] - RE104 demonstrated a favorable safety and tolerability profile, with no serious adverse events reported, and treatment-emergent adverse events were mostly mild to moderate [3][6] - The active metabolite 4-OH-DiPT appeared rapidly in plasma, correlating with clinical assessments of drug effect [3][6] Group 2: Future Trials and Indications - Reunion Neuroscience plans to initiate the REKINDLE Phase 2 trial for adjustment disorder in Q3 2025, following the RECONNECT trial [5][7] - The company is also conducting a clinical lactation study to assess the elimination of RE104 and its metabolites in breastfeeding mothers, with final data expected in the second half of 2025 [4][5] Group 3: Company Overview - Reunion Neuroscience is focused on developing next-generation psychedelic-inspired therapeutic solutions for mental health disorders, having transitioned to a private company in 2023 and completed Series A financing in 2024 [8] - The lead product candidate, RE104, is designed to provide a shorter duration psychedelic experience compared to traditional psychedelics like psilocybin, while maintaining a similar safety profile [6][8]