bezuclastinib

Phase 2

Cogent Biosciences, Inc. (COGT)

00%

What is LOA?

Phase 2

Development Phase

Upcoming Catalysts

Historical Events

Regulatory Approvals

Upcoming Catalysts

What are catalysts?

2mo

COGTPDUFA$5.4B

Phase 2

FDA PDUFA Date bezuclastinib

bezuclastinib• Advanced Systemic Mastocytosis (AdvSM)

Dec 30Confirmed

SEC

00%

Competitive Landscape

0 competitors in Advanced Systemic Mastocytosis (AdvSM)

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Drug Information

Target Indication

Advanced Systemic Mastocytosis (AdvSM)

Clinical Trial

NCT04996875

Last updated: 12/4/2025

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Source: FDA Orange Book

Drug Science

Mechanism of action & safety profile

Developer

COGT

Cogent Biosciences, Inc.

Pharmaceutical Preparations•North America•NASDAQ

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