Relmada Therapeutics Receives FDA Feedback on NDV-01
Relmada Therapeutics announced that it has received written feedback from the U.S. Food and Drug Administration, FDA, regarding the registrational development pathway for NDV-01 in 2nd-line refractory, high-grade BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ and in intermediate risk NMIBC in the adjuvant setting, where there are currently no approved therapies. In its written response to Relmada's Type B pre-IND submission, the FDA indicated that a single-arm, open-label clinical trial in this high-grade, BCG-unresponsive with CIS population is an appropriate registrational approach for NDV-01. This feedback provides a clear and efficient development path toward a potential NDA submission for NDV-01 as a bladder-sparing therapeutic option in a patient population with significant unmet need. The FDA also provided separate, supportive written feedback on the Company's planned single registrational study in intermediate-risk NMIBC in the adjuvant setting, which is expected to follow an open-label, randomized-to-observation design. Relmada continues to anticipate initiating both registrational trials in the first half of 2026.
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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.
