Relmada Therapeutics Inc

Relmada Therapeutics is a clinical-stage biotechnology company focused on developing therapies for oncology and central nervous system disorders. Its lead program, NDV-01, is a novel sustained-release intravesical formulation of gemcitabine and docetaxel being developed for non-muscle invasive bladder cancer (NMIBC), a disease affecting approximately 744,000 prevalent cases in the U.S. NDV-01 is designed to provide prolonged bladder retention and sustained drug release over approximately 10 days, administered in an office setting in under 5 minutes. The company has FDA alignment on two independent Phase 3 registrational pathways targeting second-line BCG-unresponsive NMIBC and adjuvant intermediate-risk NMIBC. Its second pipeline candidate, sepranolone, is a synthetic isoallopregnanolone that selectively modulates GABA-A receptors, being developed initially for Prader-Willi Syndrome, a rare genetic disorder with an estimated global prevalence of 350,000–400,000 patients. More than 335 patients have been treated with sepranolone in clinical trials. The company trades on Nasdaq and was recently added to the Russell 2000 and Russell 3000 indexes. Updated Aug 6, 2026