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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) has completed patient treatment in the Phase 3 RELIANCE III trial for its NMDA receptor channel blocker, REL-1017, aimed at treating major depressive disorder (MDD). Top-line data is expected early next quarter, following the FDA's Fast Track Designation for REL-1017. This trial is part of a broader clinical program including two other Phase 3 studies and an open-label safety study. Previous trials have shown promising antidepressant effects and a favorable safety profile for REL-1017.
Relmada Therapeutics (Nasdaq: RLMD) announced its corporate update and preliminary financial results for the second quarter of 2022. The FDA granted Fast Track designation for REL-1017 to treat major depressive disorder (MDD). The company appointed John Hixon as Head of Commercial to prepare for market entry. Financials revealed a net loss of $39.9 million, increasing from $26.6 million year-over-year, while R&D expenses rose to $24.6 million. As of June 30, 2022, cash and equivalents stood at approximately $212 million. Key trial results for REL-1017 are anticipated in the latter half of 2022.
Relmada Therapeutics (Nasdaq: RLMD) announced that the FDA has granted Fast Track designation to its novel NMDA receptor blocker, REL-1017, for treating major depressive disorder (MDD). This designation accelerates the development and review process for drugs addressing serious conditions. REL-1017 is currently involved in a Phase 3 trial as a monotherapy and supporting adjunctive treatment studies. The drug showed promising results in Phase 2 trials, demonstrating rapid and sustained antidepressant effects with a favorable safety profile.
Relmada Therapeutics (Nasdaq: RLMD) announced it will report Q2 2022 financial results on August 11, 2022, after market close. A conference call and live audio webcast are scheduled for the same day at 4:30 PM ET. The company’s lead product, REL-1017, is in late-stage development for major depressive disorder (MDD) and has shown promising results in a Phase 2 trial, demonstrating rapid and sustained antidepressant effects compared to placebo. The trial also confirmed a favorable safety profile, as previously noted in Phase 1 studies.
Relmada Therapeutics (Nasdaq: RLMD) announced the appointment of John Hixon as the new Head of Commercial, bringing over 36 years of experience in biopharmaceutical marketing. This strategic addition aims to enhance commercial efforts for REL-1017, a promising treatment for major depressive disorder (MDD), which is nearing Phase III clinical trial readouts. Hixon emphasized REL-1017's potential to transform treatment for patients with MDD, supported by positive Phase 2 trial results showing significant antidepressant effects and favorable safety profiles.
Relmada Therapeutics (NASDAQ: RLMD), a late-stage biotechnology firm focused on central nervous system diseases, announced that CEO Sergio Traversa will participate in the Goldman Sachs 43rd Annual Global Healthcare Conference on June 14, 2022, at 10:40am PT / 1:40pm ET. The event will discuss the company's lead program, REL-1017, a new chemical entity in late-stage development for major depressive disorder (MDD). A webcast of the presentation will be available, with an archived replay accessible for 90 days.
Relmada Therapeutics, Inc. (NASDAQ: RLMD) will participate in the 2022 Jefferies Global Healthcare Conference on June 8, 2022, from 4:00 PM to 4:25 PM ET. CEO Sergio Traversa and CFO Maged Shenouda will engage in a fireside chat. The event will be available via webcast, which can be accessed through the Relmada website, with an archived replay available for 90 days post-event. Relmada is focused on developing REL-1017, a novel treatment for major depressive disorder that has shown promising results in Phase 2 trials.
Relmada Therapeutics (Nasdaq: RLMD) announced that data on its lead candidate, REL-1017, will be showcased at the American Society of Clinical Psychopharmacology Annual Meeting from May 31 to June 3, 2022. The poster presentations will discuss human abuse potential studies comparing REL-1017 to ketamine and oxycodone. REL-1017 is under late-stage development as a rapid-acting antidepressant for major depressive disorder (MDD) and has demonstrated significant antidepressant effects in a Phase 2 trial. For more information, visit here.
Relmada Therapeutics, Inc. (Nasdaq: RLMD) reported its preliminary financial results for Q1 2022, showing a net loss of $39.7 million, or $1.40 per diluted share, compared to $22.2 million, or $1.34 per diluted share, in Q1 2021. R&D expenses increased significantly to $25.0 million from $14.0 million, driven by the Phase 3 Reliance program for REL-1017. The company appointed Gino Santini as Corporate Development Strategic Advisor and anticipates key clinical data readouts for REL-1017 in mid to late 2022. As of March 31, 2022, cash reserves totaled $220.6 million.
Relmada Therapeutics (Nasdaq: RLMD) announced the publication of preclinical data for REL-1017 in Frontiers in Pharmacology. The study confirmed that REL-1017 does not produce Olney's lesions, a concern with other NMDAR blockers. In tests, REL-1017-treated rats showed no neurotoxic effects or impaired behavior. These findings support REL-1017's safety profile, reinforcing its potential as a treatment for major depressive disorder (MDD). The drug is in late-stage development, with positive Phase 2 trial results indicating robust antidepressant effects.
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