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Relmada Therapeutics Inc

Relmada Therapeutics, Inc. is a clinical-stage biotechnology company based in the United States. It is developing NDV-01, a controlled-release intravesical formulation of gemcitabine and docetaxel, which is in Phase 2 clinical trials for patients with aggressive forms of non-muscle invasive bladder cancer. The company is also developing Sepranolone, a neurosteroid epimer of allopregnanolone, which is Phase 2b-ready for the potential treatment of Prader-Willi syndrome, Tourette syndrome, excessive tremor, and other diseases related to excessive GABAergic activity. Relmada has agreements with Asarina Pharma AB and Trigone, and was founded in 2004, with headquarters in Coral Gables, Florida.

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Relmada Therapeutics Appoints Bipin Dalmia as Chief Business Officer

Relmada Therapeutics has appointed Bipin Dalmia as Chief Business Officer. Dalmia brings nearly three decades of biopharmaceutical leadership, including deep expertise in non-muscle invasive bladder cancer, or NMIBC, and experience with the first FDA-approved intravesical gene therapy for bladder cancer patients. He will lead corporate strategy, commercial planning, and business development, reporting to CEO Sergio Traversa. The appointment comes as Relmada advances NDV-01, its novel sustained-release intravesical therapy for NMIBC, toward late-stage development. Dalmia previously served as Senior Vice President, Global Head of Portfolio Strategy and Business Development at Ferring Pharmaceuticals, where he led the U.S. launch of ADSTILADRIN and completed more than 20 strategic transactions.
RLMD · Capital · Positive Appointment of experienced CBO to lead strategy and business development as NDV-01 advances toward late-stage development.
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Biotech & Genomic Medicine▲

Relmada Therapeutics Reports Positive Phase 2 Data for NDV-01 in Bladder Cancer

Relmada Therapeutics reported positive 12-month Phase 2 data for its NDV-01 candidate, showing a 95% complete response rate in high-risk non-muscle invasive bladder cancer. The company announced the results as part of its first-quarter 2026 earnings and is well-capitalized with $234 million in cash, expected to fund operations through 2029, including the upcoming Phase 3 RESCUE registrational program set to begin in mid-2026. Relmada plans to present the findings and Phase 3 design at the American Urological Association Annual Meeting and has filed a new provisional patent application that could extend protection for NDV-01 formulations and treatment methods until 2047 if issued. Management highlighted NDV-01's potential as a best-in-class therapy with streamlined in-office administration and a favorable safety profile, supported by a recent $160 million financing.
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RLMD · Technology · Positive Positive Phase 2 data for NDV-01 shows 95% complete response rate in bladder cancer, supporting best-in-class potential.
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