Also known as: Cogent Biosciences
Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases. Its mission is to create best-in-class therapies that address the underlying causes of disease and improve patients' lives.
Cogent Biosciences has submitted a New Drug Application for bezuclastinib to treat systemic mastocytosis caused by the KIT D816V mutation, with FDA review underway and strong analyst support.
Cogent Biosciences is preparing parallel FDA submissions for bezuclastinib across three indications following positive pivotal trial results, with potential launches beginning in late 2026 and full commercialization expected by early 2027.
Cogent Biosciences presented additional SUMMIT trial data showing bezuclastinib achieved 56% improvement in symptoms at 48 weeks in NonAdvSM patients, with multiple regulatory submissions advancing toward expected commercial launch in second half of 2026.
