COGENT BIOSC.INC.DL-,001

Cogent Bioscience filed a New Drug Application with the U.S. FDA for bezuclastinib on June 30, supported by encouraging results from the APEX pivotal trial. CEO Andrew Robbins said the company is engaging closely with the FDA on three submissions and expects initial approvals by the end of 2026. The company is also advancing a JAK2 V617F mutation‑specific inhibitor with plans to file an IND in 2026. Bezuclastinib is a selective tyrosine kinase inhibitor targeting KIT mutations and is approaching Phase 3 development. » More on finance.yahoo.com

Cogent Biosciences reported early preclinical results for CGT1145 showing more than 100‑fold selectivity for JAK2 V617F over wild‑type JAK2 and JAK1/3, suggesting reduced off‑target effects that can cause low blood counts. The compound demonstrated strong oral bioavailability, consistent pharmacology across models, and potential to eradicate disease‑driving cells and support molecular remission in JAK2 V617F‑driven blood cancers. Cogent said it remains on track to file an Investigational New Drug application with the FDA later this year. » More on finance.yahoo.com

Cogent Biosciences is advancing bezuclastinib, a selective KIT D816V inhibitor, with NDAs accepted for indolent systemic mastocytosis (PDUFA Dec 2026) and imminent submission for advanced disease, and an RTOR NDA for second-line GIST where trials showed improved PFS versus standard care. The company also develops additional oncology assets (pan-KRAS, JAK2, FGFR2/3) that broaden its commercial optionality. Analysts and investors view Cogent as an attractive M&A target given de-risked data, multiple near-term catalysts and projected multibillion-dollar sales, though safety and competition remain risks. » More on finance.yahoo.com