Cogent Biosciences Inc

Cogent Biosciences is a clinical-stage biotechnology company developing precision therapies for genetically defined diseases. It has no revenue to date.

Its most advanced program is bezuclastinib, a selective tyrosine kinase inhibitor designed to potently inhibit the KIT D816V mutation and other KIT exon 17 mutations. KIT D816V drives Systemic Mastocytosis, a serious disease caused by unchecked mast cell proliferation. Exon 17 mutations also occur in advanced Gastrointestinal Stromal Tumors (GIST), a cancer strongly dependent on oncogenic KIT signaling.

Bezuclastinib is under FDA review in three indications:
- **GIST:** PDUFA date of November 30, 2026.
- **NonAdvanced Systemic Mastocytosis:** PDUFA target action date of December 30, 2026.
- **Advanced Systemic Mastocytosis:** PDUFA target action date of June 29, 2027.

The company has built a commercial team ahead of the potential launch. Its research team is also developing novel targeted therapies against mutations in ErbB2, PI3Kα, KRAS and JAK2. These include CGT4255, a CNS-penetrant mutant ErbB2 inhibitor in dose escalation; CGT1815, a pan-KRAS(ON) inhibitor; and CGT1145, a JAK2 V617F inhibitor. Updated Nov 5, 2026