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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 that clinical data for REL-1017 will be presented at the 2021 ASCP Annual Meeting from June 1-4, 2021. The presentation, titled "REL-1017 is Safe, Well-Tolerated and Exerts Rapid, Robust and Sustained Antidepressant Effects", will feature insights from Marco Pappagallo, MD. REL-1017 aims to provide a rapid-acting, oral antidepressant treatment for major depressive disorder (MDD). The FDA granted Fast Track designation for REL-1017 in April 2017, confirming its promising safety and efficacy profile.
Relmada Therapeutics (RLMD) provided a corporate update and financial results for Q1 2021. The company is advancing its lead product, REL-1017, for major depressive disorder (MDD) through its pivotal Phase 3 trials, RELIANCE I and II, which are currently enrolling participants. The company reported a net loss of $22.2 million for the quarter, up from $10.7 million in Q1 2020, with increased R&D expenses totaling $14 million. Cash reserves decreased to $102.7 million from $117.1 million at year-end 2020. Multiple key clinical data releases are expected in the coming quarters.
Relmada Therapeutics, Inc. (Nasdaq: RLMD) will release its financial results for Q1 2021 after market close on May 12, 2021. A corporate update conference call and audio webcast are scheduled for 4:30 PM ET on the same day. The company focuses on developing treatments for central nervous system diseases, particularly major depressive disorder, with its lead program, REL-1017, currently in late-stage development.
Relmada Therapeutics (Nasdaq: RLMD) announced the presentation of clinical data for its lead product candidate, REL-1017, at the virtual American Psychiatric Association Annual Meeting from May 1-3, 2021. Two posters will be showcased: one on rapid antidepressant effects in Major Depressive Disorder (MDD), and another on therapeutic response related to life-years impacted by MDD. REL-1017, an NMDA receptor channel blocker, is in late-stage studies for adjunctive MDD treatment, with previous trials showing significant efficacy and safety.
Relmada Therapeutics (Nasdaq: RLMD) announced the presentation of data on its lead product, REL-1017, at the 2021 Society of Biological Psychiatry Annual Meeting, occurring virtually from April 29 to May 1, 2021. Six posters will detail REL-1017's effects as an NMDA receptor antagonist, showing promise for treating major depressive disorder (MDD). Previous Phase 2 trials indicated rapid antidepressant effects and good safety profiles. The FDA has granted REL-1017 Fast Track designation for MDD treatment, highlighting its potential in late-stage development.
Relmada Therapeutics (Nasdaq: RLMD) announced that CEO Sergio Traversa will participate in a fireside chat at the 7th Annual Truist Securities Life Sciences Summit on May 4, 2021, at 2:40 PM ET. This event highlights the company's focus on addressing diseases of the central nervous system, specifically with their lead program, REL-1017, which is in late-stage development targeting major depressive disorder. A live webcast of the discussion will be available for 90 days post-event, and further information can be found on Relmada's investor website.
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.
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