Tag: patients

Outcome of Regenerative Medicine Advanced Therapy (RMAT) meeting provides clear regulatory pathway to approval in a continuous Phase 1 / 2 / 3 study, avoiding the requirement for an additional registrational study and accelerating time to potential approval

London – 9 July 2025 - Purespring Therapeutics, a precision nephrology company focused on transforming the treatment of kidney diseases, today announces that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for PS-002, enabling the initiation of a Phase I/II clinical trial in patients with primary IgA nephropathy (IgAN).

WALTHAM, Mass. and BOULDER, Colo., July 08, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced the pricing of its previously announced underwritten public offering of 22,222,223 shares of its common stock, offered at a public offering price of $9.00 per share. The aggregate gross proceeds to Cogent from this offering are expected to be approximately $200 million, before deducting underwriting discounts and commissions and other offering expenses. In addition, Cogent has granted the underwriters a 30-day option to purchase up to an additional 3,333,333 shares of its common stock on the same terms and conditions. All of the securities in the offering are being sold by Cogent. The offering is expected to close on or about July 10, 2025, subject to the satisfaction of customary closing conditions.