Relmada Receives FDA Feedback Endorsing Two Distinct Acceptable Pathways for NDV-01 Registration Studies in Non-Muscle Invasive Bladder Cancer
FDA Feedback on NDV-01: Relmada Therapeutics received positive feedback from the FDA regarding the planned Phase 3 trials for NDV-01 in non-muscle invasive bladder cancer (NMIBC), confirming no additional non-clinical studies are needed and supporting two potential registrational trials.
Efficacy and Safety Data: The 9-month follow-up data for NDV-01 showed a 92% overall response rate in NMIBC patients, with no progression to muscle invasive disease and no new safety signals reported.
Clinical Trial Design: The FDA indicated that a single-arm trial may be acceptable for high-grade, 2nd line BCG-unresponsive NMIBC patients, while a randomized controlled trial is acceptable for intermediate-risk NMIBC patients.
Market Potential: NDV-01, a sustained-release formulation of gemcitabine and docetaxel, aims to address the significant unmet needs in NMIBC, which represents 75-80% of bladder cancer cases and has limited treatment options.
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Relmada Therapeutics Sets Price for $100 Million Underwritten Common Stock and Pre-Funded Warrant Offering
Offering Details: Relmada Therapeutics announced the pricing of an underwritten offering of 40,142,000 shares of common stock at $2.20 per share, along with pre-funded warrants for an additional 5,315,000 shares, aiming to raise approximately $100 million before expenses.
Use of Proceeds: The funds will be utilized for working capital, clinical studies for regulatory approvals, development of product candidates, and potential acquisitions or licensing of complementary technologies.
Investor Participation: Notable investors in the offering include Janus Henderson Investors, Ferring Ventures SA, and OrbiMed, with Jefferies and Leerink Partners serving as joint book-running managers.
Forward-Looking Statements: The announcement includes forward-looking statements regarding the offering's completion and intended use of proceeds, highlighting the inherent risks and uncertainties involved.
