Core Insights - Reunion Neuroscience is advancing RE104, a psychedelic-inspired therapeutic solution, targeting significant unmet needs in mental health disorders, specifically Adjustment Disorder (AjD) and postpartum depression (PPD) [1][2][3] Company Overview - Reunion Neuroscience is a clinical-stage biopharmaceutical company focused on developing next-generation psychedelic therapies for underserved mental health conditions [7] - The company aims to address conditions like AjD, PPD, and Generalized Anxiety Disorder (GAD) with innovative treatments that have no current FDA-approved options [1][7] Product Development - RE104 is the only psychedelic therapeutic in advanced clinical development for AjD in the U.S., designed to provide rapid and sustained relief from distress and dysfunction [2][3] - The company has initiated the REKINDLE Phase 2 trial for RE104 in AjD, with topline results expected in 2027, and plans to start a Phase 3 trial for PPD in 2026 [1][4] - Positive topline data from the RECONNECT Phase 2 trial for PPD demonstrated a significant reduction in depression severity, supporting the advancement of RE104 into further trials [4] Market Need - AjD affects approximately 500,000 individuals in the U.S. annually, particularly those with serious medical illnesses, and is associated with poorer medical outcomes and quality of life [3][5][6] - Current treatments for AjD are inconsistent, highlighting the need for effective therapies like RE104 [6] Clinical Trial Details - The REKINDLE trial is a randomized, double-blind, dose-controlled study assessing the safety and efficacy of RE104 in adult patients with AjD [3][4] - Primary and secondary endpoints include changes in depression and anxiety severity measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) and Hamilton Anxiety Scale (HAM-A) [3]

Core Insights - Reunion Neuroscience has successfully closed its Series A financing, raising a total of $133 million, with the final tranche increasing from $21 million to $51 million due to meeting certain efficacy parameters in the RECONNECT study [1][2]. Company Developments - The funds from the Series A financing will fully support the ongoing REKINDLE Phase 2 clinical trial for Adjustment Disorder (AjD) and will also be used to expand the clinical development of RE104 into generalized anxiety disorder (GAD) [2]. - Reunion plans to initiate the RECLAIM Phase 2 clinical trial for RE104 in adults with GAD in the first quarter of 2026 [2][3]. Product Information - RE104 is a proprietary prodrug designed to provide a short, acute psychoactive experience, differing from traditional psychedelics [6]. - The RECLAIM trial will evaluate the safety and efficacy of RE104, with the primary endpoint being the change in Hamilton Anxiety Scale (HAM-A) score from baseline at Week 4 [4]. Market Context - GAD affects approximately 6.8 million adults in the U.S. annually, with current treatment options having significant limitations, leading to a substantial unmet need for effective alternatives [3][4]. - Current treatments for GAD include SSRIs, SNRIs, and psychosocial therapies, but many patients do not respond adequately to these options [3]. Clinical Validation - The RECONNECT study demonstrated clinically meaningful reductions in MADRS scores for postpartum depression, supporting the advancement of RE104 into a Phase 3 trial in 2026 [5]. - The company has received positive feedback from industry experts regarding the potential of RE104 to improve treatment outcomes for patients with limited alternatives [4]. Future Plans - Reunion Neuroscience is also investigating RE104 for additional neuropsychiatric indications, aiming to address significant unmet needs in mental health treatment [7].

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]