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CORAL GABLES, Fla. - Relmada Therapeutics, Inc. (NASDAQ: RLMD), a clinical-stage biotechnology company with a market capitalization of $13.31 million, shared positive initial data from a Phase 2 study of its investigational drug NDV-01, demonstrating significant clinical activity in the treatment of non-muscle invasive bladder cancer (NMIBC). According to InvestingPro data, the company maintains a strong liquidity position with more cash than debt on its balance sheet, though analysts anticipate continued losses this year. The findings, presented at the American Urology Association 2025 Annual Meeting, revealed that 90% of patients achieved high-grade disease-free status at some point following treatment.
The study assessed the efficacy of NDV-01, a sustained-release formulation of chemotherapy agents gemcitabine and docetaxel, designed to simplify outpatient treatment. The company’s stock has shown remarkable momentum, with InvestingPro reporting a nearly 100% return over the past week, though it remains significantly below its 52-week high of $4.47. At the three-month evaluation, the overall response rate (ORR) was 85%, with 83.3% of patients with papillary disease showing high-grade recurrence-free survival (HGRFS), and 100% of patients with carcinoma in situ (CIS) achieving a complete response (CR). By six months, all evaluable patients (n=7) reached disease-free status.
Dr. Yair Lotan, Chief of Urologic Oncology at UT Southwestern Medical Center, noted the potential of NDV-01 to significantly change NMIBC management due to its simplified delivery and increased exposure to the drug. Sergio Traversa, CEO of Relmada, expressed confidence in NDV-01’s potential to become a leading therapy for NMIBC, highlighting its strong responses and tolerability.
The safety profile of NDV-01 was favorable, with no treatment-related adverse events above Grade 1 reported. The most common side effects were mild and transient, including urinary urgency, flank pain, and dysuria. No discontinuations due to adverse events occurred.
The Phase 2 open-label study is ongoing, with 26 patients enrolled to date. The primary efficacy endpoints are safety and complete response rate at 12 months, with secondary endpoints including duration of response and event-free survival.
NMIBC accounts for a significant portion of bladder cancer cases, with a high recurrence rate. NDV-01’s potential to improve outcomes and expand treatment options is underscored by the multi-billion-dollar U.S. NMIBC market, with global numbers expected to rise. With a current ratio of 4.45, InvestingPro analysis shows the company maintains strong financial flexibility to pursue its development programs, despite current market challenges. Discover 10+ additional exclusive insights and detailed financial analysis available through InvestingPro’s comprehensive research report.
Relmada Therapeutics focuses on advancing therapies for targeted patient populations. Alongside NDV-01, the company is preparing to further develop sepranolone for compulsion-related disorders. The information reported is based on a press release statement.
In other recent news, Relmada Therapeutics Inc. reported a narrower net loss per share for the fourth quarter of 2024, with figures showing a reduction to $0.62 from the previous year’s $0.84 per share. The company also disclosed a decrease in cash reserves, which now stand at $44.9 million, down from $96.3 million in 2023. Relmada has been active in expanding its product pipeline, announcing the acquisition of two new product candidates targeting bladder cancer and compulsion-related disorders. Additionally, the company has discontinued Phase 3 studies for RAL1017 in major depressive disorder. Analysts have noted these strategic moves and the company’s focus on maintaining operational efficiency. The firm plans to advance Phase 2b studies for Sepranolone in Tourette’s syndrome and Prader-Willi syndrome. Upcoming FDA interactions and presentations at medical meetings are anticipated to provide further insights into these developments.
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