TSX lower after index logs fresh record closing high
CORAL GABLES, Fla. - Relmada Therapeutics (NASDAQ:RLMD), a $52 million market cap biotech company whose stock has surged over 470% in the past six months, has provided an update on its clinical pipeline, highlighting two Phase 2 candidates that were added following a strategic review earlier this year, according to a shareholder letter released Wednesday.According to InvestingPro data, the company maintains a strong financial position with more cash than debt and a healthy current ratio of 4.1x, providing runway for its development programs.
The company reported that its NDV-01 treatment for non-muscle invasive bladder cancer showed a 91% complete response rate at the six-month follow-up in Phase 2 trials. The drug, a sustained-release formulation of gemcitabine and docetaxel, is being prepared for a Phase 3 registrational trial expected to begin in the first half of 2026. Discover more insights about RLMD with InvestingPro, which offers exclusive analysis and 8 additional ProTips about the company’s financial health and market position.
To strengthen its oncology program, Relmada appointed Raj S. Pruthi as Chief Medical Officer-Oncology and Yair Lotan as Chair of the Clinical Advisory Board.
The company’s second key candidate, sepranolone, is being developed for compulsivity disorders, with plans to initiate a Phase 2 study for Prader-Willi Syndrome in the first half of 2026. The company cited positive proof-of-concept data in Tourette’s syndrome as support for the drug’s potential.
Upcoming milestones include nine-month and twelve-month results from the NDV-01 Phase 2 trial in Q4 2025 and Q1 2026 respectively, product supply scale-up in the second half of 2025, and U.S. IND clearance in the first half of 2026.
Sergio Traversa, Chief Executive Officer of Relmada, described 2025 as "a truly transformational year" for the company in the shareholder letter.
Relmada Therapeutics focuses on developing therapies for oncology-related and central nervous system conditions. The information in this article is based on a press release statement from the company.
In other recent news, Relmada Therapeutics reported its second-quarter 2025 earnings, revealing a narrower-than-expected loss. The company posted an earnings per share of -$0.30, which was better than analyst projections of -$0.40. This improvement highlights effective financial management by the company. Additionally, Raj S. Pruthi, MD, Chief Medical Officer-Urology of Relmada Therapeutics, acquired 55,000 shares of the company’s common stock in open market transactions. This purchase was disclosed in a recent SEC filing. These developments indicate ongoing activity and interest in the company from both management and the investment community.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.