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) reported its preliminary financial results for Q4 and full-year 2022, highlighting a net loss of $37.9 million, or $1.28 per diluted share, up from a loss of $34.4 million, or $1.80 per diluted share, a year prior. Full-year losses increased to $157 million from $125.8 million in 2021. The company is focused on advancing REL-1017 for major depressive disorder, making changes to the ongoing Study 302 and initiating Study 304. Cash, cash equivalents, and short-term investments totaled approximately $148.3 million as of December 31, 2022. A conference call is scheduled for March 23, 2023.
Relmada Therapeutics (Nasdaq: RLMD), a late-stage biotechnology firm specializing in CNS diseases, will announce its financial results for Q4 and full-year 2022 post-market on March 23, 2023. This will be followed by a corporate update conference call and webcast at 4:30 PM ET the same day. The company is advancing its lead program, REL-1017, targeting major depressive disorder as an adjunctive treatment. Forward-looking statements highlight potential risks, such as failure in clinical trial efficacy, regulatory approval challenges, and other uncertainties impacting future performance.
Relmada Therapeutics (Nasdaq: RLMD) announced the appointment of Fabiana Fedeli as an independent director on its Board of Directors. Fedeli, currently Chief Investment Officer at M&G Investments, brings extensive experience in international capital markets and corporate strategy. Her expertise is expected to enhance the Board's diversity and strengthen Relmada's potential commercialization efforts for its lead program, REL-1017, an adjunctive treatment for major depressive disorder (MDD). The Board looks forward to leveraging Fedeli’s insights for long-term shareholder value.
Relmada Therapeutics (Nasdaq: RLMD) has appointed Cedric O'Gorman, MD, as Chief Medical Officer. With over 20 years in life sciences, O'Gorman will oversee the clinical and regulatory aspects of the late-stage REL-1017 development program, targeting major depressive disorder (MDD). Previously, he held leadership roles in clinical development at Alpha Cognition and Axsome Therapeutics, focusing on CNS therapeutics. CEO Sergio Traversa emphasized O'Gorman's relevant expertise, particularly in aligning with REL-1017's development as they prepare for FDA regulatory discussions.
Relmada Therapeutics (Nasdaq: RLMD) announced the results of the RELIANCE I study, evaluating REL-1017 for Major Depressive Disorder. The study did not achieve its primary endpoint of significant improvement in depression symptoms compared to placebo. Despite this, the REL-1017 treatment arm showed a MADRS reduction of 15.1 points versus 12.9 points for placebo. A post-hoc analysis excluding two high enrolling centers revealed a 4.1 point difference. Relmada is implementing protocol changes for its ongoing RELIANCE II trial based on findings from RELIANCE I and III.
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.