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COGT PDUFA Date: Bezuclastinib

FDA decision (PDUFA) target 2026-12-30 · Cogent Biosciences Inc. · Non-Advanced Systemic Mastocytosis

COGT run-up into the PDUFA (last ~120 days)

$39.97$31.02
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-12-30
Drug / candidateBezuclastinib
IndicationNon-Advanced Systemic Mastocytosis
CompanyCogent Biosciences Inc.
Market-cap tierMid
Cohort decision-day move (history)±2% median
ClinicalTrials.govNCT05186753 · Breakthrough Therapy Designation (BTD)

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FAQ

When is the COGT PDUFA date?
The FDA PDUFA target date for COGT (Cogent Biosciences Inc.) is 2026-12-30 for Bezuclastinib. Dates are company/FDA-sourced and can slip — verify against primary filings.
What is COGT's drug Bezuclastinib?
Bezuclastinib is Cogent Biosciences Inc.'s candidate under FDA review for Non-Advanced Systemic Mastocytosis.
What typically happens to a mid-cap stock into a PDUFA date?
Historically, mid-cap names had a median decision-day move around ±2% (694-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.