Cogent Biosciences is a clinical-stage biotech company developing precision therapies for rare, genetically defined diseases. Its lead asset is bezuclastinib, a selective small molecule tyrosine kinase inhibitor targeting the KIT D816V mutation and related KIT exon 17 mutations. Cogent is pursuing bezuclastinib across two indications: systemic mastocytosis (SM), a disease driven by abnormal mast cell proliferation, and gastrointestinal stromal tumors (GIST), a cancer where patients commonly develop resistance to first-line imatinib via secondary KIT mutations. Cogent reported positive Phase 3 trial results across both SM and GIST in late 2025, submitted an NDA for non-advanced SM in December 2025, and expects to submit an NDA for advanced SM and GIST in the first half of 2026. Cogent is targeting a U.S. commercial launch in the second half of 2026, building an internal sales force for the domestic market while pursuing partnerships internationally. Beyond bezuclastinib, Cogent is building an early-stage pipeline of small molecule inhibitors targeting oncogenic mutations in FGFR2/3, HER2, PI3Kα, KRAS, and JAK2 — all in Phase 1 or earlier. The company is pre-revenue and funds operations through capital raises. Its future revenue will depend on bezuclastinib pricing, patient volumes, and reimbursement coverage. Cogent licenses bezuclastinib from Plexxikon and owes tiered royalties on net sales. Manufacturing is fully outsourced to third-party contract manufacturers.