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 its Q4 and full-year 2021 financial results on March 23, 2022. The company reported a net loss of $34.4 million for Q4 2021, up from $20.8 million in Q4 2020, with total research and development expenses increasing to $25.3 million. For the full year, the net loss was $125.8 million, resulting in a loss per share of $7.16. Notably, Relmada completed two human abuse potential studies for its lead drug, REL-1017, confirming no significant abuse risk. The firm anticipates key data releases throughout 2022, aiming to advance its clinical programs.
Relmada Therapeutics (Nasdaq: RLMD) announced it will disclose its financial results for Q4 and the full year ended December 31, 2021, after market close on March 23, 2022. A corporate update conference call and live audio webcast is scheduled for 4:30 PM ET on the same date. Relmada focuses on central nervous system diseases, particularly major depressive disorder (MDD), and is advancing its lead program, REL-1017, which has shown promising results in clinical trials as a treatment for MDD.
Relmada Therapeutics (NASDAQ: RLMD), a biotechnology firm focused on CNS diseases, announced participation in two conferences. CEO Sergio Traversa and CFO Maged Shenouda will engage in fireside chats at Needham & Company's 1st Annual Neuroscience Forum on March 16, 2022, at 9:30am ET, and Oppenheimer's 32nd Annual Healthcare Conference on March 17, 2022, at 1:20pm ET. Webcasts for both events will be accessible on Relmada's website, with archived replays available for 90 days post-event. Relmada is advancing its lead program, REL-1017, for major depressive disorder.
Relmada Therapeutics (NASDAQ: RLMD) announced significant findings from its human abuse potential study for REL-1017, a treatment for major depressive disorder (MDD). Results showed that all tested doses of REL-1017 indicated a statistically significant difference from intravenous ketamine but were comparable to placebo regarding likability. The study involved 51 recreational drug users and adhered to FDA guidance. These findings contribute to the body of evidence supporting REL-1017's lack of abuse potential, vital for its New Drug Application process. A conference call is scheduled to discuss details.
Relmada Therapeutics, Inc. (NASDAQ: RLMD), a biotechnology firm focused on central nervous system diseases, announced its participation in the 11th Annual SVB Leerink Global Healthcare Conference. CEO Sergio Traversa and CFO Maged Shenouda will engage in a fireside chat on February 17, 2022, at 8:00 AM Eastern Time. A live webcast will be available and can be replayed for 90 days post-event. Relmada’s lead program, REL-1017, is under late-stage development for major depressive disorder (MDD), demonstrating promising results in Phase 2 trials.
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.