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 announced positive initial Phase 2 data for NDV-01, their treatment for non-muscle invasive bladder cancer (NMIBC), at AUA2025. The study showed remarkable efficacy with 90% of patients achieving high-grade disease-free status.
Key results include:
- 85% overall response rate at 3 months (17/20 patients)
- 83.3% high-grade recurrence-free survival in papillary disease
- 100% complete response in CIS patients
- 100% disease-free status at 6 months for evaluable patients
The treatment showed strong effectiveness across all patient groups, including both BCG-naïve and BCG-unresponsive patients. NDV-01's safety profile was favorable, with only mild, temporary side effects reported. The treatment can be administered in under 10 minutes, potentially offering a significant advancement in outpatient bladder cancer care.
The ongoing study has enrolled 26 patients total, with 20 reaching the 3-month assessment mark. The company aims to position NDV-01 as a leading therapy for NMIBC treatment.
Relmada Therapeutics (NASDAQ: RLMD) has announced its upcoming presentation at the American Urology Association (AUA2025) conference in Las Vegas, scheduled for April 26-29th, 2025. The company will present data on NDV-01, their investigational treatment, during the Clinical Trials in Progress Session.
The abstract, focusing on a prospective open-label study, will evaluate the safety and efficacy of intravesical sustained release Gemcitabine Docetaxel combination (NDV-01) in High Risk NMIBC. The presentation is scheduled for April 28, 2025, from 10:04 AM PT to 10:12 AM PT in Hall C, The Square, Learning Lab.
Relmada Therapeutics (Nasdaq: RLMD) has announced its upcoming presentation at the American Urology Association (AUA2025) conference in Las Vegas, scheduled for April 26-29th, 2025. The company will present data on NDV-01, a combination therapy of intravesical sustained release Gemcitabine and Docetaxel.
The presentation, categorized as Paradigm-Shifting, will focus on a prospective open-label study evaluating NDV-01's safety and efficacy in High Risk NMIBC. The abstract presentation is scheduled for April 28, 2025, at 10:04 AM PT.
Relmada Therapeutics (NASDAQ: RLMD) has announced its upcoming presentation at the American Urology Association (AUA2025) conference in Las Vegas, scheduled for April 26-29, 2025. The company will present data on NDV-01, a combination therapy of intravesical sustained release Gemcitabine and Docetaxel.
The presentation, categorized as Paradigm-Shifting, will focus on a prospective open-label study evaluating the safety and efficacy of NDV-01 in High Risk NMIBC. The abstract will be presented on Monday, April 28, 2025, at 10:04 AM PT.
Relmada Therapeutics (RLMD) reported Q4 and full-year 2024 results, highlighting progress in two Phase 2 programs. The company expects topline Phase 2 data for NDV-01, treating high-grade non-muscle invasive bladder cancer, at AUA 2025 in April. They're also advancing sepranolone, a neurosteroid, towards Phase 2b studies in Tourette syndrome and Prader-Willi Syndrome.
Financial highlights include: Cash position of $44.8 million as of December 31, 2024; Q4 net loss of $18.6 million ($0.62 per share), improved from $25.1 million ($0.84 per share) in Q4 2023; Full-year 2024 net loss of $80 million ($2.65 per share), compared to $98.8 million in 2023. R&D expenses decreased to $46.2 million from $54.8 million in 2023.
The company expects to initiate registration-track studies for both NDV-01 and sepranolone between late Q4 2025 and early 2026, with current cash runway extending into H1 2026.
Relmada Therapeutics (NASDAQ: RLMD), a clinical-stage biotechnology company, has scheduled its fourth quarter 2024 financial results conference call and webcast for Thursday, March 27, 2025, at 4:30 PM ET. The company will discuss its business progress and financial performance for the quarter ended December 31, 2024.
Investors can access the conference through US dial-in (1-877-407-0792) or International dial-in (1-201-689-8263) with conference code 13751458. A webcast replay will be available in the Investors section of Relmada's website.
Relmada Therapeutics (NASDAQ: RLMD) has secured an exclusive licensing agreement with Trigone Pharma for NDV-01, a novel sustained-release bladder cancer treatment. NDV-01 is a gemcitabine/docetaxel formulation targeting non-muscle invasive bladder cancer (NMIBC), which affects approximately 600,000 U.S. patients with 62,000 new diagnoses annually.
The drug candidate is currently in Phase 2 trials, with topline efficacy and safety data expected at the American Urological Association meeting in Las Vegas (April 26-29, 2025). NDV-01's key advantages include:
- Sustained delivery lasting up to 10 days versus hours for conventional treatments
- Potential for both inpatient and outpatient clinic use
- Good safety profile and easy dosing procedure
This acquisition, along with the recently acquired sepranolone, represents Relmada's strategy to diversify its pipeline while balancing risk and upside potential. The company positions NDV-01 as a potential first-line therapy for NMIBC, particularly beneficial for patients unresponsive to BCG therapy.
Relmada Therapeutics (NASDAQ: RLMD) has acquired Sepranolone, a Phase 2b ready neurosteroid therapy for Tourette syndrome (TS), from Asarina Pharma AB. Sepranolone is a first-in-class GABAA Modulating Steroid Antagonist that targets the GABAA pathway to counteract Allopregnanolone effects in TS and other compulsive disorders.
In a Phase 2a study involving 26 subjects over 12 weeks, Sepranolone demonstrated promising results, including a 28% reduction in tic severity (p=0.051) and significant improvements in secondary endpoints: 69% increase in Quality of Life, 50% reduction in impairment, and 44% reduction in premonitory urge to tic. The treatment showed no CNS off-target effects or systemic side effects.
The company views this acquisition as strategic in addressing unmet needs in CNS disorders and plans to host an investor update on Sepranolone's development later in 2025.
Relmada Therapeutics (Nasdaq: RLMD) announced the discontinuation of its Reliance II and Relight Phase 3 studies of REL-1017 following a data monitoring committee evaluation. The company will continue advancing the Phase 1 study of REL-P11, an investigational treatment for metabolic disease. In response to these developments, Relmada has initiated a process to explore strategic alternatives to maximize shareholder value, including potential sale of company assets, mergers, acquisitions, or other strategic transactions. The company is engaging a financial advisor for the strategic review process but has not set a specific timeline for completion.
Relmada Therapeutics (NASDAQ: RLMD) announced that the Phase 3 Reliance II trial for REL-1017, designed to evaluate its efficacy as an adjunctive treatment for major depressive disorder (MDD), is unlikely to meet its primary efficacy endpoint according to the Data Monitoring Committee's interim analysis. No new safety concerns were identified.
The company will evaluate the complete dataset to determine next steps for the REL-1017 program while continuing to advance the Phase 1 study of REL-P11 for metabolic disease. Relmada maintains a strong financial position with approximately $54.1 million in cash and cash equivalents as of September 30, 2024.