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 the publication of Phase 2 data for REL-1017 as an adjunctive treatment for major depressive disorder (MDD) in the American Journal of Psychiatry. The study demonstrated REL-1017's favorable safety and tolerability profile, with no serious adverse events reported. Key findings reveal significant antidepressant effects and sustained improvement in Montgomery–Asberg Depression Scale scores compared to placebo. Relmada aims to advance REL-1017 into Phase 3 trials following these promising results.
Relmada Therapeutics (Nasdaq: RLMD) announced the closing of its upsized public offering of 10,147,059 shares at $17.00 each, generating approximately $172.5 million in gross proceeds. This offering included the underwriters' option for an additional 1,323,529 shares. The net proceeds will be utilized for the development of REL-1017, an innovative treatment for depression, alongside other corporate purposes. The offering was managed by Goldman Sachs, Jefferies, and Guggenheim Securities.
Relmada Therapeutics (Nasdaq: RLMD) announced an upsized public offering of 8,823,530 shares at $17.00 per share, expected to yield approximately $150 million in gross proceeds before discounts and expenses. The offering, set to close on December 13, 2021, is fully underwritten and includes a 30-day option for underwriters to purchase an additional 1,323,529 shares. Funds will support research and development for REL-1017, aimed at treating depression, alongside general corporate purposes.
Relmada Therapeutics (Nasdaq: RLMD) announced its plan to offer $100 million in common stock through an underwritten public offering. The offering may include an additional 15% of shares, subject to market conditions. Proceeds will fund research and development for REL-1017, a treatment for depression, and for general corporate purposes. Goldman Sachs, Jefferies, and Guggenheim Securities are managing the offering. The offering is made under an existing shelf registration statement. There is no assurance on completion timing or terms.
Relmada Therapeutics, Inc. (Nasdaq: RLMD) announced that data from its human abuse potential study of REL-1017 will be presented at the 60th Annual Meeting of the American College of Neuropsychopharmacology from December 5-8, 2021, in San Juan, Puerto Rico. The poster session is scheduled for December 7, showcasing REL-1017's lack of meaningful opioid abuse liability. REL-1017 is a novel NMDA receptor channel blocker aimed at treating major depressive disorder (MDD). Results from a Phase 2 trial indicated significant antidepressant effects, supporting its late-stage clinical development.
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.
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