공고 • Jul 23
Reunion Neuroscience Inc. Announces First Patient Dosed in Phase 2 Clinical Trial of RE104 for the Treatment of Postpartum Depression Reunion Neuroscience Inc. 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. The RECONNECT Phase 2 clinical trial (NCT06342310) is a multicenter, randomized, double-blind, parallel-group, active dose-controlled clinical trial evaluating the safety and efficacy of a single subcutaneous dose of RE104 in adult female patients with moderate-to-severe PPD. The primary endpoint of the trial is the change in total Montgomery-Åsberg Depression Rating Scale (MADRS) score, a 10-item clinician rated scale measuring depression severity from baseline, at Day 7. Key secondary endpoints include the change in total MADRS score from baseline at Day 1, 14 and 28, MADRS response indicating a = 50% reduction in symptoms, MADRS remission with a score of = 10, as well as safety and tolerability. The Company’s lead product candidate, RE104, is a proprietary, potential best-in-class, patented prodrug of 4-OH-DiPT. Reunion designed RE104 to deliver a short duration psychedelic experience compared to longer duration psychedelics like psilocybin. In a Phase 1 clinical trial, RE104 produced a psychedelic 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. RE104 is currently being evaluated in the RECONNECT Phase 2 (NCT06342310) clinical trial, a multicenter, randomized, double-blind, active dose-controlled clinical trial in moderate-to-severe Postpartum Depression (PPD) patients. Reunion is actively evaluating the use of RE104 in additional neuropsychiatric indications, including adjustment disorder in cancer patients, where there remains a significant unmet need that is not addressed by the current standard of care. Postpartum depression (PPD) is one of the most common medical complications during and after pregnancy and is estimated to affect approximately 10-15% of all mothers of newborns. PPD is a form of major depression that can severely impact women and their families. According to the Centers for Disease Control and Prevention, the leading underlying cause of pregnancy-related death during the first postpartum year are due to mental health conditions, with suicide being the leading manner of death. Women suffering from PPD often experience significant changes in mood, appetite and sleep contributing to feelings of hopelessness, lack of concentration, loss of energy, poor self-esteem and maternal disinterest. 공고 • Sep 20
Reunion Neuroscience Inc. Announces FDA Clearance of IND Application to Initiate A Phase 2 Study of Re104 for the Treatment of Postpartum Depression Reunion Neuroscience Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 2 study of RE104, a novel serotonergic psychedelic compound, for the treatment of postpartum depression (PPD). The Phase 2 study, the RECONNECT Trial, is a multicenter, randomized, double-blind, parallel-group, active-dose placebo-controlled study, which will evaluate the safety and efficacy of a single subcutaneous dose of RE104 in adult female patients with PPD. The study is expected to begin in fourth quarter 2023 with a targeted data readout in late 2024. 공고 • Aug 19
Reunion Neuroscience Inc. Files Form 15 Reunion Neuroscience Inc. has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its Common Shares under the Securities Exchange Act of 1934, as amended. 공고 • Aug 02
Reunion Neuroscience's Shares to Be De-Listed from the Toronto Stock Exchange on the Close of Markets on or Around August 2, 2023 Reunion Neuroscience Inc. and MPM BioImpact ("MPM") announced the completion of the previously announced plan of arrangement (the "Arrangement") effective August 1, 2023, whereby MPM acquired Reunion in an all-cash transaction valued at approximately USD 13.1 million by way of a court-approved plan of arrangement under Section 192 of the Canada Business Corporations Act. Pursuant to the terms and conditions of a definitive arrangement agreement entered into by Reunion and affiliates of MPM on May 31, 2023, all holders of outstanding common shares ("Shares") of Reunion are entitled to receive USD 1.12 in cash for each Share held immediately prior to the effective time of the Arrangement. As previously announced, the Arrangement was approved by shareholders of the Company at its special meeting of shareholders held on July 12, 2023 and by the Ontario Superior Court of Justice (Commercial List) on July 14, 2023. With the completion of the Arrangement, the Shares are expected to be de-listed from the Toronto Stock Exchange on the close of markets on or around August 2, 2023. The Company is in the process of applying to cease to be a reporting issuer under applicable Canadian securities laws. The Shares will be delisted from the Nasdaq Global Select Market and deregistered under the Securities Exchange Act of 1934, as amended. 
