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Relmada Therapeutics, Inc. (Nasdaq: RLMD) is a clinical-stage biotechnology company focusing on the development of treatments for central nervous system (CNS) disorders, particularly major depressive disorder (MDD). The company's lead product candidate, REL-1017, is a new chemical entity (NCE) and NMDA receptor channel blocker. It is currently being evaluated in late-stage clinical trials as an adjunctive treatment for MDD in adults.
REL-1017 has shown promise in clinical studies, demonstrating rapid and sustained improvements in depressive symptoms with a favorable safety profile. The ongoing clinical development program includes two Phase 3 trials: Reliance II (Study 302) and Relight (Study 304), which are designed to assess the efficacy and safety of REL-1017 in patients with MDD who have an inadequate response to their current antidepressant therapies.
Relmada Therapeutics is also advancing a novel non-psychedelic/low dose psilocybin program (REL-P11) for the treatment of metabolic conditions. Initial preclinical studies have shown significant therapeutic potential in improving metabolic parameters, and the company plans to initiate Phase 1 and Phase 2a trials in obese patients with steatotic liver disease.
In recent corporate updates, Relmada has reported significant progress in its clinical development plans, with study enrollments proceeding as expected and additional preclinical and Phase 1 studies supporting future regulatory submissions. The company is well-funded to continue its research and development activities, aiming for multiple clinical milestones and potential regulatory filings in the near future.
Relmada Therapeutics (Nasdaq: RLMD) announced the presentation of data on its lead product candidate, REL-1017, at the ASPET Annual Meeting, which runs virtually from April 27 to April 30, 2021. The poster titled, REL-1017 (esmethadone) Did Not Produce Initial or Cumulative Neurotoxic Effects, highlights REL-1017's safety profile and its potential as a rapid-acting antidepressant. Previously, REL-1017 received FDA Fast Track designation for treating major depressive disorder (MDD) as an adjunctive treatment following positive Phase 2 trial results.
Relmada Therapeutics (Nasdaq: RLMD) has initiated the second pivotal Phase 3 trial of its lead candidate REL-1017 as an adjunctive treatment for major depressive disorder (MDD), which affects over 17 million Americans. The RELIANCE program consists of two studies, each targeting 364 patients who have not adequately responded to standard antidepressants. Primary outcomes will be measured by the Montgomery and Asberg Depression Rating Scale (MADRS) at day 28. Top-line data from both trials is expected in the first half of 2022, building on promising results from a previous Phase 2 trial.
Relmada Therapeutics (Nasdaq: RLMD) announced its fourth quarter and full year 2020 financial results, reporting a net loss of $20.8 million for Q4 and $59.5 million for the year. The company is advancing its lead candidate, REL-1017, intended for major depressive disorder (MDD). Following a successful Phase 2 trial, the Phase 3 program is underway, with the first trial, RELIANCE I, actively enrolling patients. Relmada has significant cash reserves of approximately $117.1 million, which is projected to support upcoming studies and milestones into 2022.
Relmada Therapeutics (Nasdaq: RLMD) will report its fourth quarter and full-year financial results for 2020 on March 23, 2021, after market close. This announcement precedes a conference call and live audio webcast scheduled for the same day at 4:30 PM ET. The company focuses on central nervous system diseases, particularly major depressive disorder, with its lead program, REL-1017, in late-stage development. A replay of the webcast will be accessible on their Investor Relations page.
Relmada Therapeutics, Inc. (Nasdaq: RLMD) announced that CEO Sergio Traversa will participate in a fireside chat at the Oppenheimer 31st Annual Healthcare Conference on March 16, 2021, at 10:40 a.m. ET. A live webcast will be available on the investor section of the company's website, with a replay accessible for 90 days post-event.
Relmada focuses on central nervous system diseases, particularly major depressive disorder, and is advancing its lead program, REL-1017, into late-stage development.
Relmada Therapeutics, Inc. (Nasdaq: RLMD) announced that CEO Sergio Traversa will participate in a fireside chat at the 2021 SVB Leerink Global Healthcare Conference on February 25, 2021, at 3:40 p.m. ET. The event will be webcast live, with a replay available for 90 days. Relmada focuses on addressing central nervous system diseases, particularly major depressive disorder (MDD), with its lead program, REL-1017, in late-stage development as an adjunctive treatment for MDD in adults. The press release includes forward-looking statements regarding risks and uncertainties.
Relmada Therapeutics (Nasdaq: RLMD) announced the enrollment of the first patient in its Phase 3 trial (RELIANCE I) for REL-1017 as an adjunctive treatment for major depressive disorder (MDD). CEO Sergio Traversa highlighted this as a significant milestone, emphasizing guidance from the FDA based on positive Phase 2 results. The Phase 3 program features two trials involving 400 MDD patients across 55 sites in the U.S. Key endpoints include assessing changes in depression scores at day 28, with top-line results expected in the first half of 2022.
Relmada Therapeutics, Inc. (Nasdaq: RLMD) will have its CEO, Sergio Traversa, participate in two virtual investor conferences. The first is the Jefferies London Healthcare Conference on November 19, 2020, at 10:50 AM EST, with a live webcast available on their website. The second is the Piper Sandler 32nd Annual Healthcare Conference, where a fireside chat will be accessible starting November 23, 2020. Relmada specializes in therapies for CNS diseases, focusing on major depressive disorder (MDD) with its lead program REL-1017.
Relmada Therapeutics (Nasdaq: RLMD) has expanded its leadership with the appointments of Paolo Manfredi, M.D., as Acting Chief Scientific Officer and Marco Pappagallo, M.D., as Acting Chief Medical Officer. Both bring extensive experience in CNS therapies. The company is on track to start its pivotal Phase III trial of REL-1017 for major depressive disorder (MDD) by Q4 2020, along with other significant milestones planned for 2021, including human abuse potential studies and additional trials. REL-1017 has demonstrated promising results in previous studies.
Relmada Therapeutics (Nasdaq: RLMD) received a Notice of Allowance from the Canadian Intellectual Property Office for its patent on REL-1017, a novel NMDA receptor antagonist. This patent broadens its intellectual property in Canada, a key market for treating psychological disorders such as depression and anxiety. The company is set to initiate its Phase 3 program for REL-1017 in Q4 2020 after receiving FDA clearance to proceed without further trials. REL-1017 showed promising Phase 2 results, demonstrating significant antidepressant effects and a favorable safety profile.
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