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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, Inc. (NASDAQ: RLMD) announced updates on its late-stage development for REL-1017, a treatment for major depressive disorder (MDD). The new RELIANCE III trial will randomize 364 patients, expected to finish by Q2 2022. The FDA confirmed no two-year carcinogenicity study is required, and existing data is sufficient for assessing cardiac safety in regulatory submissions. REL-1017 has shown promising results in previous trials, indicating potential for rapid, effective treatment of MDD.
Relmada Therapeutics (NASDAQ: RLMD) announced that CEO Sergio Traversa will present at the Oppenheimer Fall Healthcare Life Sciences and MedTech Summit on September 21, 2021, at 12:25 PM ET. Attendees can access a live webcast of the event here or through the Relmada website. The company is advancing REL-1017, a novel NMDA receptor channel blocker, in late-stage development for major depressive disorder (MDD), demonstrating promising results in Phase 2 trials. An archived replay will be available for 90 days post-event.
Relmada Therapeutics, Inc. (NASDAQ: RLMD) announced that CEO Sergio Traversa will present at the 19th Annual Morgan Stanley Global Healthcare Conference on September 10, 2021, at 12:30 PM ET. A live webcast of the event will be available, and participants can access it through the provided link. Relmada's lead program, REL-1017, is a novel NMDA receptor blocker in late-stage development for major depressive disorder (MDD), showing promising results in Phase 2 trials with significant improvements over placebo. An archived replay will be available post-presentation.
Relmada Therapeutics (Nasdaq: RLMD) reported financial results for Q2 and the first half of 2021. The pivotal Phase 3 RELIANCE program for REL-1017 is progressing, with a successful human abuse potential study showing significant safety results. The company also acquired rights to a novel psilocybin program, enhancing growth prospects. In Q2, R&D expenses surged to $17.3 million, contributing to a net loss of $26.6 million or $1.56 per share. Cash reserves stood at $109.1 million as of June 30, 2021, down from $117.1 million at year-end 2020.
Relmada Therapeutics, Inc. (Nasdaq: RLMD) announced it will release its financial results for the second quarter of 2021 on August 10, 2021, after the market closes. The company, which focuses on CNS diseases, will host a conference call at 4:30 PM ET on the same day to discuss the results. Investors can access a replay of the webcast on the company’s website. Relmada is in late-stage development for its lead program, REL-1017, aimed at treating major depressive disorder.
Relmada Therapeutics (Nasdaq: RLMD) announced top-line results from a human abuse potential (HAP) study for REL-1017, a novel NMDA receptor channel blocker aimed at treating major depressive disorder (MDD). The study demonstrated that at all tested doses (25 mg, 75 mg, 150 mg), REL-1017 showed a statistically significant difference in likability compared to oxycodone (40 mg), indicating minimal abuse potential. These findings support the ongoing development of REL-1017, highlighting its potential as a safe alternative treatment for MDD. Further data will be submitted to the FDA.
Relmada Therapeutics (Nasdaq: RLMD) has acquired development and commercial rights to a novel psilocybin program from Arbormentis LLC for $15 million upfront, plus potential milestone payments exceeding $150 million. This acquisition, focused on neurological and psychiatric disorders, aligns with Relmada's commitment to advancing CNS treatments. The company’s lead program, REL-1017, is in Phase III for major depressive disorder. The partnership aims to leverage expertise in neuroplasticity to develop innovative therapies addressing mental health challenges.
Relmada Therapeutics, Inc. (Nasdaq: RLMD) announced that data on REL-1017, its lead product candidate, will be showcased in two poster presentations at the CPDD 83rd Annual Meeting from June 21 to June 24, 2021. Both presentations, scheduled for June 21, 2021, will detail findings from studies demonstrating that REL-1017 showed no reinforcing properties compared to oxycodone and exhibited no withdrawal effects or physical dependence. REL-1017 is an NMDA receptor channel blocker in late-stage development as a treatment for major depressive disorder (MDD).
Relmada Therapeutics, Inc. (Nasdaq: RLMD) announced that CEO Sergio Traversa will participate in a fireside chat at the Goldman Sachs 42nd Annual Global Healthcare Conference on June 10, 2021, at 8:00 a.m. Eastern Time. Interested parties can access a live webcast of the event through the company's website, where an archived replay will be available for one year. Relmada focuses on major depressive disorder (MDD) and is advancing its lead program, REL-1017, a novel NMDA receptor channel blocker, currently in late-stage development.
Relmada Therapeutics, Inc. (Nasdaq: RLMD) has announced that CEO Sergio Traversa will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on June 4, 2021, at 10:30 am Eastern Time. The event will provide insights into the company's focus on treating central nervous system diseases, particularly major depressive disorder (MDD), with its lead program, REL-1017, currently in late-stage development. Participants can access the live webcast via the provided links, with an archived replay available for 30 days post-event.
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