DEC 30 2026
Cogent Biosciences — bezuclastinib $COGT
for non-advanced systemic mastocytosis (NonAdvSM)
Accepted MAR 16 2026.
About
Non-advanced systemic mastocytosis is a rare disorder where defective mast cells accumulate in the body, causing a range of debilitating symptoms. Bezulastinib is a small molecule drug designed to selectively block the mutated KIT D816V protein that drives the growth of these abnormal mast cells. By targeting this specific mutation, the drug could potentially reduce the mast cell burden and alleviate the symptoms of the disease.
Pivotal trial
This is an open-label, two-part Phase 2 study investigating CGT9486 for the treatment of patients with Advanced Systemic Mastocytosis (AdvSM), including patients with Aggressive SM (ASM), SM with Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL).
Source: ClinicalTrials.gov
Also in development
Drug Watch — recent news on bezuclastinib
- Will FDA’s Streamlined Bezuclastinib Review in ASM Change Cogent Biosciences’ (COGT) Narrative? - Yahoo Finance
- Cogent Biosciences: A Closer Look At Bezuclastinib And Its Long-Term Potential (NASDAQ:COGT) - Seeking Alpha
- FDA Accepts Bezuclastinib NDA for Advanced Systemic Mastocytosis - Targeted Oncology
- US FDA Accepts NDA for Bezuclastinib in Advanced Systemic Mastocytosis - The Dermatology Digest
- FDA Accepts NDA for Bezuclastinib in Advanced Systemic Mastocytosis - OncLive
Sponsor Watch — recent news on Cogent Biosciences
- Will FDA’s Streamlined Bezuclastinib Review in ASM Change Cogent Biosciences’ (COGT) Narrative?
- Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) for Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM)
- Cogent Bioscience (COGT) Files New Drug Application For Bezuclastinib
- Cogent Biosciences Announces Submission of New Drug Application (NDA) for Bezuclastinib in Advanced Systemic Mastocytosis (AdvSM)
- Cogent Biosciences Announces Preclinical Data from Novel JAK2 V617F Inhibitor at the 2026 European Hematology Association (EHA) Congress