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 that data on its lead candidate, REL-1017, will be showcased at the American Society of Clinical Psychopharmacology Annual Meeting from May 31 to June 3, 2022. The poster presentations will discuss human abuse potential studies comparing REL-1017 to ketamine and oxycodone. REL-1017 is under late-stage development as a rapid-acting antidepressant for major depressive disorder (MDD) and has demonstrated significant antidepressant effects in a Phase 2 trial. For more information, visit here.
Relmada Therapeutics, Inc. (Nasdaq: RLMD) reported its preliminary financial results for Q1 2022, showing a net loss of $39.7 million, or $1.40 per diluted share, compared to $22.2 million, or $1.34 per diluted share, in Q1 2021. R&D expenses increased significantly to $25.0 million from $14.0 million, driven by the Phase 3 Reliance program for REL-1017. The company appointed Gino Santini as Corporate Development Strategic Advisor and anticipates key clinical data readouts for REL-1017 in mid to late 2022. As of March 31, 2022, cash reserves totaled $220.6 million.
Relmada Therapeutics (Nasdaq: RLMD) announced the publication of preclinical data for REL-1017 in Frontiers in Pharmacology. The study confirmed that REL-1017 does not produce Olney's lesions, a concern with other NMDAR blockers. In tests, REL-1017-treated rats showed no neurotoxic effects or impaired behavior. These findings support REL-1017's safety profile, reinforcing its potential as a treatment for major depressive disorder (MDD). The drug is in late-stage development, with positive Phase 2 trial results indicating robust antidepressant effects.
Relmada Therapeutics, Inc. (Nasdaq: RLMD) will report its financial results for Q1 2022 on May 5, 2022, after market close. The company is focused on developing treatments for central nervous system diseases, particularly major depressive disorder (MDD). Notably, its lead program, REL-1017, is in late-stage development and has shown significant antidepressant effects in Phase 2 trials. The company will host a conference call at 4:30 PM ET on the same day to discuss the results and updates.
Relmada Therapeutics, Inc. (Nasdaq: RLMD) announced presentations at the Ketamine & Related Compounds International Hybrid Conference 2022, taking place from April 4-6 in Oxford, UK, and online. The data focuses on REL-1017, a candidate for treating major depressive disorder (MDD), featuring two poster presentations on its human abuse potential and an oral presentation detailing a Phase 2 study's results. REL-1017 demonstrated rapid antidepressant effects and a favorable safety profile, positioning it as a promising therapy for MDD.
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.
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