Welcome to our dedicated page for Relmada Therapeutics news (Ticker: RLMD), a resource for investors and traders seeking the latest updates and insights on Relmada Therapeutics stock.
Relmada Therapeutics, Inc. (Nasdaq: RLMD) is a clinical-stage biotechnology company whose news flow centers on the development of NDV-01 for non-muscle invasive bladder cancer (NMIBC) and sepranolone for central nervous system conditions. Company press releases frequently highlight clinical data readouts, regulatory interactions, and financing events that shape the outlook for its pipeline.
Recent news has focused on NDV-01, a sustained-release, intravesical formulation of gemcitabine and docetaxel in development for NMIBC. Relmada has reported 6‑month and 9‑month follow-up data from an open-label Phase 2 study, including complete response rates at various time points, safety findings, and outcomes such as absence of progression to muscle-invasive disease and lack of radical cystectomy among reported patients. Updates also describe treatment-related adverse events and their severity profile.
Another key theme in RLMD news is FDA regulatory feedback. The company has announced written guidance from the FDA supporting two potential registrational study paths for NDV-01: a single-arm trial in high-grade, 2nd-line BCG-unresponsive NMIBC with carcinoma in situ and a randomized-to-observation trial in intermediate-risk NMIBC in the adjuvant setting. These items are often accompanied by timelines for anticipated Phase 3 trial initiation and expectations around a 505(b)(2) regulatory pathway.
Relmada’s news feed also covers corporate and financial updates, including quarterly financial results, underwritten equity offerings, Nasdaq listing compliance notices, and additions to its clinical advisory board. For sepranolone, press releases describe its GABAA-modulating mechanism and planned Phase 2 development in Prader-Willi syndrome and other compulsivity-related disorders. Investors monitoring RLMD news can use this page to follow clinical milestones, regulatory developments, capital-raising activities, and other disclosures that the company furnishes through GlobeNewswire and SEC-related announcements.
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.
Relmada Therapeutics, Inc. (Nasdaq: RLMD) will report its financial results for Q1 2022 on May 5, 2022, after market close. The company is focused on developing treatments for central nervous system diseases, particularly major depressive disorder (MDD). Notably, its lead program, REL-1017, is in late-stage development and has shown significant antidepressant effects in Phase 2 trials. The company will host a conference call at 4:30 PM ET on the same day to discuss the results and updates.
Relmada Therapeutics, Inc. (Nasdaq: RLMD) announced presentations at the Ketamine & Related Compounds International Hybrid Conference 2022, taking place from April 4-6 in Oxford, UK, and online. The data focuses on REL-1017, a candidate for treating major depressive disorder (MDD), featuring two poster presentations on its human abuse potential and an oral presentation detailing a Phase 2 study's results. REL-1017 demonstrated rapid antidepressant effects and a favorable safety profile, positioning it as a promising therapy for MDD.