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 CEO Sergio Traversa will present at the Oppenheimer Fall Healthcare Life Sciences and MedTech Summit on September 21, 2021, at 12:25 PM ET. Attendees can access a live webcast of the event here or through the Relmada website. The company is advancing REL-1017, a novel NMDA receptor channel blocker, in late-stage development for major depressive disorder (MDD), demonstrating promising results in Phase 2 trials. An archived replay will be available for 90 days post-event.
Relmada Therapeutics, Inc. (NASDAQ: RLMD) announced that CEO Sergio Traversa will present at the 19th Annual Morgan Stanley Global Healthcare Conference on September 10, 2021, at 12:30 PM ET. A live webcast of the event will be available, and participants can access it through the provided link. Relmada's lead program, REL-1017, is a novel NMDA receptor blocker in late-stage development for major depressive disorder (MDD), showing promising results in Phase 2 trials with significant improvements over placebo. An archived replay will be available post-presentation.
Relmada Therapeutics (Nasdaq: RLMD) reported financial results for Q2 and the first half of 2021. The pivotal Phase 3 RELIANCE program for REL-1017 is progressing, with a successful human abuse potential study showing significant safety results. The company also acquired rights to a novel psilocybin program, enhancing growth prospects. In Q2, R&D expenses surged to $17.3 million, contributing to a net loss of $26.6 million or $1.56 per share. Cash reserves stood at $109.1 million as of June 30, 2021, down from $117.1 million at year-end 2020.
Relmada Therapeutics, Inc. (Nasdaq: RLMD) announced it will release its financial results for the second quarter of 2021 on August 10, 2021, after the market closes. The company, which focuses on CNS diseases, will host a conference call at 4:30 PM ET on the same day to discuss the results. Investors can access a replay of the webcast on the company’s website. Relmada is in late-stage development for its lead program, REL-1017, aimed at treating major depressive disorder.
Relmada Therapeutics (Nasdaq: RLMD) announced top-line results from a human abuse potential (HAP) study for REL-1017, a novel NMDA receptor channel blocker aimed at treating major depressive disorder (MDD). The study demonstrated that at all tested doses (25 mg, 75 mg, 150 mg), REL-1017 showed a statistically significant difference in likability compared to oxycodone (40 mg), indicating minimal abuse potential. These findings support the ongoing development of REL-1017, highlighting its potential as a safe alternative treatment for MDD. Further data will be submitted to the FDA.
Relmada Therapeutics (Nasdaq: RLMD) has acquired development and commercial rights to a novel psilocybin program from Arbormentis LLC for $15 million upfront, plus potential milestone payments exceeding $150 million. This acquisition, focused on neurological and psychiatric disorders, aligns with Relmada's commitment to advancing CNS treatments. The company’s lead program, REL-1017, is in Phase III for major depressive disorder. The partnership aims to leverage expertise in neuroplasticity to develop innovative therapies addressing mental health challenges.
Relmada Therapeutics, Inc. (Nasdaq: RLMD) announced that data on REL-1017, its lead product candidate, will be showcased in two poster presentations at the CPDD 83rd Annual Meeting from June 21 to June 24, 2021. Both presentations, scheduled for June 21, 2021, will detail findings from studies demonstrating that REL-1017 showed no reinforcing properties compared to oxycodone and exhibited no withdrawal effects or physical dependence. REL-1017 is an NMDA receptor channel blocker in late-stage development as a treatment for major depressive disorder (MDD).
Relmada Therapeutics, Inc. (Nasdaq: RLMD) announced that CEO Sergio Traversa will participate in a fireside chat at the Goldman Sachs 42nd Annual Global Healthcare Conference on June 10, 2021, at 8:00 a.m. Eastern Time. Interested parties can access a live webcast of the event through the company's website, where an archived replay will be available for one year. Relmada focuses on major depressive disorder (MDD) and is advancing its lead program, REL-1017, a novel NMDA receptor channel blocker, currently in late-stage development.
Relmada Therapeutics, Inc. (Nasdaq: RLMD) has announced that CEO Sergio Traversa will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on June 4, 2021, at 10:30 am Eastern Time. The event will provide insights into the company's focus on treating central nervous system diseases, particularly major depressive disorder (MDD), with its lead program, REL-1017, currently in late-stage development. Participants can access the live webcast via the provided links, with an archived replay available for 30 days post-event.
Relmada Therapeutics (Nasdaq: RLMD) announced that clinical data for REL-1017 will be presented at the 2021 ASCP Annual Meeting from June 1-4, 2021. The presentation, titled "REL-1017 is Safe, Well-Tolerated and Exerts Rapid, Robust and Sustained Antidepressant Effects", will feature insights from Marco Pappagallo, MD. REL-1017 aims to provide a rapid-acting, oral antidepressant treatment for major depressive disorder (MDD). The FDA granted Fast Track designation for REL-1017 in April 2017, confirming its promising safety and efficacy profile.