Relmada Therapeutics, Inc. is a clinical-stage biotechnology company, which engages in addressing diseases of the central nervous system. It develops esmethadone, an N-methyl-D-aspartate receptor antagonist for the treatment of CNS diseases, and oral agent for depression and other potential indications. The company was founded by Paolo Manfredi on May 31, 2012 and is headquartered in Coral Gables, FL.
Clinical Trials
13
1 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Completed
6
46.1%
No Longer Available
1
7.7%
Not yet recruiting
1
7.7%
Recruiting
1
7.7%
Terminated
2
15.4%
Withdrawn
2
15.4%
No approval data available
- Relmada Therapeutics presented 6-month follow-up data from its ongoing Phase 2 trial of NDV-01, a sustained-release intravesical formulation of gemcitabine and docetaxel for non-muscle invasive bladder cancer. - The company reported a 92% complete response rate at any time point from 9-month data and plans to advance NDV-01 into Phase 3 studies in two indications by the first half of 2026. - NDV-01 targets high-risk and intermediate-risk NMIBC, representing approximately 80% of new cases annually or about 54,000 patients in the United States. - The treatment offers a potential bladder-sparing, in-office therapy that can be administered in less than 10 minutes without anesthesia or specialized equipment.
- Relmada Therapeutics completed a $100 million underwritten offering of common stock and pre-funded warrants to fund clinical development of its oncology and central nervous system therapies. - The clinical-stage biotechnology company will use proceeds for regulatory studies, product development, and potential acquisitions to advance lead candidates NDV-01 and sepranolone. - Major institutional investors including Janus Henderson, Ferring Ventures, and OrbiMed participated in the offering, demonstrating strong investor confidence in the company's pipeline.
- Relmada Therapeutics has officially halted development of esmethadone, an investigational NMDA receptor blocker for major depressive disorder, following three consecutive Phase III trial failures. - The company terminated its January 2018 licensing agreement for the drug after the RELIANCE III, RELIANCE I, and RELIANCE II trials all failed to demonstrate significant efficacy versus placebo. - Relmada is now shifting focus to strategic product acquisitions, with primary emphasis on NDV-01, a Phase II sustained-release formulation of gemcitabine and docetaxel for non-muscle invasive bladder cancer. - The decision reflects broader challenges in depression drug development, with multiple biotechnology companies experiencing recent setbacks in this therapeutic area.
- Relmada Therapeutics appointed renowned urologic oncologist Dr. Yair Lotan as Chair of its Clinical Advisory Board to guide NDV-01 development for non-muscle invasive bladder cancer. - The company also named Dr. Raj S. Pruthi as Chief Medical Officer-Urology, bringing over 25 years of experience in urologic oncology and clinical trials. - NDV-01 is a sustained-release intravesical formulation of gemcitabine and docetaxel that showed promising Phase 2 results at AUA 2025, with Phase 3 trials expected to begin in H1 2026. - The appointments strengthen Relmada's expertise as it advances NDV-01 to address the significant unmet need in NMIBC, which affects over 600,000 patients in the U.S. with high recurrence rates of 50-75% over 7 years.
- A comprehensive pipeline report reveals over 75 companies are developing innovative treatments for major depressive disorder, with several promising candidates advancing through Phase III trials. - Key emerging therapies include SAGE Therapeutics' SAGE-217 oral neuroactive steroid, Relmada Therapeutics' REL-1017 NMDAR channel blocker, and COMPASS Pathways' psilocybin-based COMP360. - The MDD therapeutics market was valued at $7.2 billion in 2023 across seven major markets, with significant growth expected through 2034 driven by novel mechanisms of action. - Several candidates have received FDA Fast Track designation, including REL-1017 and VistaGen's PH10 nasal spray, highlighting regulatory support for innovative depression treatments.
- Relmada Therapeutics has acquired exclusive worldwide rights to NDV-01, a sustained-release intravesical formulation of gemcitabine and docetaxel for non-muscle invasive bladder cancer, with Phase 2 data expected in April 2025. - NDV-01 offers significant advantages over conventional treatments, including 10-day sustained drug release versus hours for traditional delivery, potential for outpatient administration, and a strong safety profile based on established chemotherapy agents. - The licensing agreement includes a $3.5 million upfront payment plus 10% equity stake to Trigone Pharma, with potential milestone payments up to $200 million, targeting a U.S. market with approximately 600,000 NMIBC patients.
- Relmada Therapeutics discontinues Phase 3 trials (RELIANCE II and RELIGHT) of REL-1017 for depression after unfavorable data monitoring committee evaluation. - The company will continue Phase 1 study of REL-P11, a psilocybin derivative, for treating metabolic diseases, shifting focus from CNS to metabolic disorders. - Relmada initiates strategic review, considering options like asset sales, mergers, or acquisitions to maximize shareholder value amid financial pressures. - The company is engaging a financial advisor but has not set a timeline for the strategic review process, with no guarantee of any transactions.
- Relmada Therapeutics' Phase 3 Reliance II trial of REL-1017 as an adjunctive treatment for major depressive disorder is unlikely to meet its primary efficacy endpoint. - The Independent Data Monitoring Committee's interim analysis indicated futility, with no new safety concerns identified during the study. - Relmada will assess the full dataset to determine the future of the REL-1017 program and continues to advance REL-P11 for metabolic disease. - Despite this setback, Relmada reports a strong financial position with $54.1 million in cash and cash equivalents as of September 30, 2024.
- Relmada Therapeutics is advancing REL-1017 for major depressive disorder (MDD), with interim analysis results expected by the end of 2024. - The company's cash reserves stand at $54.1 million, sufficient to support operations through near-term milestones into 2025, despite a Q3 net loss of $21.7 million. - A Phase 1 safety study for REL-P11, a psilocybin-based candidate for metabolic disease, is underway, with Phase 2a study planned for 2025. - The Data Management Committee will provide limited interim readout information, focusing on potential futility of the Reliance 2 Phase 3 study.
- Relmada Therapeutics anticipates interim analysis results from its Reliance II study for major depressive disorder by year-end. - The company is set to begin enrollment in the REL-P11 Phase I study, expanding its clinical development pipeline. - Despite progress, Relmada expresses concerns about having sufficient liquidity to sustain operations beyond the next year. - The company's net loss for the quarter was $21.7 million, with research and development expenses totaling $11.1 million.
