Tag: mutations

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.

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 that it has commenced an underwritten public offering of $150 million of its shares of common stock. In addition, Cogent intends to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of its shares of common stock on the same terms and conditions. All of the securities in the offering are being offered by Cogent. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering.

ROCKVILLE, Md. and SUZHOU, China, July 07, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) (“Ascentage Pharma” or the “Company”), a global biopharmaceutical company dedicated to addressing unmet medical needs in cancers, announced the appointments of Veet Misra, Ph.D., as the Company’s Chief Financial Officer, and Mr. Eric Huang, as Senior Vice President of Global Corporate Development and Finance. Both Dr. Misra and Mr. Huang will report directly to Dajun Yang, M.D., Ph.D., the Company’s Chairman & Chief Executive Officer.

-- Patients treated with bezuclastinib showed a superior mean change in total symptom score at 24 weeks (-24.3 points vs. -15.4 points, -8.91 point placebo-adjusted difference; p=0.0002), compared to patients treated with placebo, establishing new benchmarks for placebo-adjusted and absolute symptomatic improvement for this patient population --

-- Bezuclastinib demonstrated a powerful effect on mast cell burden, with 87.4% of patients treated with bezuclastinib achieving at least 50% reduction in serum tryptase compared to 0% of patients treated with placebo --

SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, July 03, 2025 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq:ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced that on July 1, 2025 (the “Grant Date”), ORIC granted a total of 9,000 non-qualified stock options and 1,600 restricted stock units to one new non-executive employee who began their employment with ORIC in June 2025.