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 an update on its financial results for Q3 and the first nine months of 2022. The company reported a net loss of $39.4 million, or $1.31 per diluted share, for Q3, improving from a net loss of $42.6 million in the same period last year. For the nine months, the net loss rose to $119.1 million, compared to $91.4 million in 2021. Relmada is evaluating data from its Phase 3 RELIANCE III trial for REL-1017 for major depressive disorder (MDD) while expecting results from ongoing studies in 2022 and 2023. The company maintains a strong balance sheet with $184.2 million in cash.
Relmada Therapeutics (Nasdaq: RLMD) announced it will release its financial results for Q3 and nine months ended September 30, 2022, after market close on November 10, 2022. A conference call and webcast will follow at 4:30 PM Eastern Time.
The company continues to advance REL-1017, a novel NMDA receptor channel blocker, in late-stage development for major depressive disorder, reporting positive results from its Phase 2 trial.
Relmada Therapeutics, Inc. (Nasdaq: RLMD) announced that its RELIANCE III study of REL-1017, aimed at treating Major Depressive Disorder (MDD), did not meet its primary endpoint of statistically significant symptom improvement compared to placebo. The treatment group showed a MADRS reduction of 14.8 points, marginally higher than the placebo's 13.9 points. Despite these disappointing results, the safety profile of REL-1017 remained favorable. Relmada continues enrollment in two ongoing Phase 3 trials (RELIANCE I and II) for REL-1017 as an adjunctive treatment for MDD.
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.
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