Lysergic acid diethylamide

-- AjD Represents an Area of Significant Unmet Need; No U.S. Food and Drug Administration (FDA)-Approved Therapies Available -- -- Following Positive Topline Data in RECONNECT Phase 2 Trial, Expect to Initiate Phase 3 Trial of RE104 in Postpartum Depression (PPD) in 2026 and RECLAIM Phase 2 Trial in Generalized Anxiety Disorder (GAD) in 1Q 2026-- MORRISTOWN, N.J., Sept. 30, 2025 (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 the dosing of the first patient in REKINDLE, a Phase 2 clinical trial evaluating RE104 for the treatment of adjustment disorder (AjD) in patients with cancer and other medical illnesses. Topline results from the study are anticipated in 2027. With RE104, Reunion Neuroscience aims to offer patients an effective, safe and fast-acting psychotropic medication to relieve distress and dysfunction in patients with AjD. RE104 is the only psychedelic therapeutic in advanced clinical development for an AjD indication in the United States. “AjD is an area of significant need for patients with cancer and other serious diseases, both because of the depressive and anxiety symptoms it introduces and the poorer medical outcomes it can engender,” said Manish Agrawal, M.D., Co-Founder and Chief Executive Officer of Sunstone Therapies and REKINDLE investigator. “The unique mechanism of action of RE104, designed to deliver both rapid and sustained benefit, represents a promising new approach that may transform the treatment of patients suffering from AjD. I am proud to be part of this pioneering effort and look forward to evaluating RE104 in REKINDLE.” “Dosing the first patient in our REKINDLE Phase 2 trial marks a significant milestone in our mission to bring RE104 to patients living with underserved mental health disorders. AjD is a debilitating and underrecognized condition that affects the emotional well-being and medical outcomes of approximately 500,000 people in the United States each year, and for which there are currently no approved options,” said Greg Mayes, President and Chief Executive Officer of Reunion Neuroscience. “Our confidence in RE104 is buoyed by positive topline data from the RECONNECT trial of RE104 for the treatment of PPD, which demonstrated RE104’s ability to deliver rapid and safe symptom relief following a single dose. We look forward to bringing similar benefit to patients facing the emotional toll of cancer and other serious medical illnesses, as we expand our clinical development efforts and work to realize the full potential of RE104.” The REKINDLE Phase 2 clinical trial (NCT07002034) is a randomized, double-blind, parallel-group, dose-controlled clinical trial evaluating the safety and efficacy of RE104 for the treatment of AjD in adult patients with cancer and other medical illnesses. The primary endpoint of the trial is the change from baseline in total Montgomery-Åsberg Depression Rating Scale (MADRS) score, a clinician rated scale measuring depression severity. A key secondary endpoint of the trial is the change from baseline in the Hamilton Anxiety Scale (HAM-A), a clinician rated scale measuring anxiety severity. The study will also assess the safety and tolerability of RE104. Reunion Neuroscience recently announced topline data from RECONNECT (NCT06342310), a multicenter, randomized, double-blind, dose-controlled Phase 2 clinical trial evaluating the safety and efficacy of a single subcutaneous dose of RE104 in adult female patients with moderate-to-severe PPD. RECONNECT met its primary endpoint, demonstrating a clinically-meaningful reduction in MADRS scores through Day 28, as well as a favorable safety and tolerability profile. These data support Reunion Neuroscience’s plans to advance RE104 into a Phase 3 trial for the treatment of PPD in 2026. Reunion Neuroscience also plans to commence RECLAIM, a Phase 2 clinical trial in Generalized Anxiety Disorder (GAD), in the first quarter of 2026. About Adjustment Disorder (AjD)AjD is a mental health condition defined as a disproportionate reaction to a stressful life event or change, which impacts the ability to function and is characterized by depression, anxiety and/or other behavioral and mood disturbances. Serious medical illnesses are known to be a key precipitant of AjD; it is estimated that approximately 500,000 people in the United States are diagnosed with AjD each year following a medical or health-related stressor. Depressive and anxiety symptoms in medically ill patients with AjD can be associated with poorer medical outcomes, treatment compliance and quality of life as well as increased health care utilization. Current treatments for AjD are not consistently effective, and there are no therapies presently approved by the U.S. Food and Drug Administration (FDA) for its treatment. Additional information on RE104’s potential in AjD can be found in the white paper authored by Reunion Neuroscience, “Adjustment Disorder Associated With Medical Illness: Unmet Needs and Rationale for RE104 as a Novel Psychedelic Therapy.” About RE104The Company’s lead product candidate, RE104, is a proprietary, potential best-in-class, patented prodrug of 4-OH-DiPT, which is administered via a single subcutaneous injection. Reunion designed RE104 to deliver a shorter acute psychoactive experience when compared to longer experience duration psychedelics such as psilocybin or LSD. About Reunion Neuroscience, Inc.Reunion Neuroscience is 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. Reunion is actively investigating the use of its lead product candidate, RE104, in postpartum depression, adjustment disorder and generalized anxiety disorder and may in the future expand to additional neuropsychiatric indications where there remains a significant unmet need that is not addressed by the current standard of care. Reunion has advanced a lead candidate, RE245, from its non-psychedelic discovery program and plans to file an IND in 2026. To learn more, visit https://reunionneuro.com, and follow Reunion on LinkedIn and Bluesky. For further information:IR Inquiries:Hannah DeresiewiczPrecision AQhannah.deresiewicz@precisionaq.com PR Inquiries:Ashley Murphy Precision AQashley.murphy@precisonaq.com

MindMed detailed promising Phase 2b results for its LSD treatment for generalized anxiety disorder as it presses on with three late-stage trials in the increasingly competitive field of psychedelic medicine. The company published data Thursday in JAMA, almost two years after first announcing that specific doses of the drug were successful at improving patients’ anxiety symptoms compared to placebo. The 100 µg dose that went into Phase 3 testing also showed a statistically significant improvement in patients’ depression symptoms, a secondary endpoint of the anxiety trial. MindMed now faces a question that all companies in the budding psychedelic field have to answer: How do you sell the drug? Less than half of the patients in the 100 µg dose arm of the Phase 3 study met the criteria to safely end the session after eight hours, but that jumped to 70% by hour nine. CEO Rob Barrow said in an interview that MindMed is not trying to fit LSD within the infrastructure and dosing period established by Johnson & Johnson and its blockbuster esketamine depression treatment. Spravato is administered in a two-hour dosing and evaluation period, twice a week for the first month of administration. That drops to one dose a week in the second month. “We don’t want to be,” he said. “This is different, and it’s different for many important reasons.” MindMed’s MM120 was administered as a one-time monotherapy, with follow-up continuing up to 12 weeks after dosing. Barrow and medical chief Dan Karlin hope that clinics administering their drug could be reimbursed based on time spent with the patient. “If you’re getting paid by the hour, and you can just fill up a room for a day with a patient and get paid for that entire day, that is extremely attractive to clinics as well, because then they don’t have to worry about turnover,” Barrow said. More than 90% of patients treated with 100 µg experienced visual perception changes, like hallucinating, and 40% reported nausea. One patient in the smaller 50 µg group experienced a panic attack 97 days after the dosing session that was deemed unrelated to the LSD, while one patient in the 100 µg group dropped out of the study due to adverse events. No patients engaged in self-harm or suicidal behavior during the trial, according to MindMed, and patients with a history of suicidal ideation who were in the trial did not report an increase in severity. Roughly 9% of the patients randomized to receive either LSD or placebo had to drop out for not following the protocol, which included taking prohibited drugs that could have affected MM120’s efficacy or safety. Karlin said patients who discontinued the trial due to protocol non-adherence did so because they experienced symptoms related to tapering off previously prescribed anxiety medications. “You see more of that in the less efficacious doses and in placebo,” he said. None of the patients in the 100 µg dose arm dropped out due to lack of protocol adherence. The first of two Phase 3 studies in generalized anxiety disorder is expected to read out in the first half of next year, with a second readout slated for the second half of 2026. A third Phase 3 trial in patients with major depressive disorder should have data in the second half of 2026. Patients in those trials will have the opportunity to receive up to four additional doses of 100 µg of MM120 over a 40-week open-label period if their anxiety or depression symptoms exceed certain thresholds. Karlin said this should simulate how people interact with the drug in the real world, where some experience a durable, single-dose effect, and others need some form of repeat dosing. “It’ll allow us to start to really provide some guidance for real-world use and what patients and physicians can expect from the drug,” he said.