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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) reported its preliminary financial results for Q4 and full-year 2022, highlighting a net loss of $37.9 million, or $1.28 per diluted share, up from a loss of $34.4 million, or $1.80 per diluted share, a year prior. Full-year losses increased to $157 million from $125.8 million in 2021. The company is focused on advancing REL-1017 for major depressive disorder, making changes to the ongoing Study 302 and initiating Study 304. Cash, cash equivalents, and short-term investments totaled approximately $148.3 million as of December 31, 2022. A conference call is scheduled for March 23, 2023.
Relmada Therapeutics (Nasdaq: RLMD), a late-stage biotechnology firm specializing in CNS diseases, will announce its financial results for Q4 and full-year 2022 post-market on March 23, 2023. This will be followed by a corporate update conference call and webcast at 4:30 PM ET the same day. The company is advancing its lead program, REL-1017, targeting major depressive disorder as an adjunctive treatment. Forward-looking statements highlight potential risks, such as failure in clinical trial efficacy, regulatory approval challenges, and other uncertainties impacting future performance.
Relmada Therapeutics (Nasdaq: RLMD) announced the appointment of Fabiana Fedeli as an independent director on its Board of Directors. Fedeli, currently Chief Investment Officer at M&G Investments, brings extensive experience in international capital markets and corporate strategy. Her expertise is expected to enhance the Board's diversity and strengthen Relmada's potential commercialization efforts for its lead program, REL-1017, an adjunctive treatment for major depressive disorder (MDD). The Board looks forward to leveraging Fedeli’s insights for long-term shareholder value.
Relmada Therapeutics (Nasdaq: RLMD) has appointed Cedric O'Gorman, MD, as Chief Medical Officer. With over 20 years in life sciences, O'Gorman will oversee the clinical and regulatory aspects of the late-stage REL-1017 development program, targeting major depressive disorder (MDD). Previously, he held leadership roles in clinical development at Alpha Cognition and Axsome Therapeutics, focusing on CNS therapeutics. CEO Sergio Traversa emphasized O'Gorman's relevant expertise, particularly in aligning with REL-1017's development as they prepare for FDA regulatory discussions.
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