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) provided a corporate update and disclosed financial results for Q3 and YTD 2021. The company's REL-1017 program for treating major depressive disorder is on track, with several key data catalysts expected in 2022. The FDA has confirmed that no additional carcinogenicity or TQT cardiac studies will be required for regulatory approval. Financially, Q3 R&D expenses surged to $34 million, while the net loss for the quarter was $42.6 million or $2.44 per share. As of September 30, 2021, cash and short-term investments stood at $88.1 million.
Relmada Therapeutics, Inc. (NASDAQ: RLMD) announced that CEO Sergio Traversa and CFO Maged Shenouda will present at the Jefferies London Healthcare Conference on November 17, 2021, at 8:00 AM Eastern Time. The event will be accessible via a live webcast, and an archived replay will be available for 90 days. Relmada is focused on advancing REL-1017, a novel NMDA receptor channel blocker in late-stage development for treating major depressive disorder (MDD). The ongoing RELIANCE Phase 3 program aims to evaluate REL-1017's efficacy as a rapid-acting antidepressant.
Relmada Therapeutics, Inc. (Nasdaq: RLMD) will report its third quarter and nine-month financial results after market close on November 11, 2021. A conference call and live audio webcast are scheduled for 4:30 PM Eastern Time on the same day. The company is advancing its lead program, REL-1017, designed for major depressive disorder (MDD). This innovative NMDA receptor channel blocker is in late-stage development, having shown promising results in previous trials.
Relmada Therapeutics, Inc. (Nasdaq: RLMD) announced the presentation of data on its lead product candidate, REL-1017, at the Neuroscience Education Institute (NEI) Congress on November 5, 2021. The event will feature eight poster presentations and an interactive exhibit booth in Colorado Springs, CO. REL-1017 is being developed for treating major depressive disorder and has shown promising results in clinical trials. Registration is required for virtual and in-person participation.
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.