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Home › PDUFA Calendar › COGT

COGT PDUFA Date: Bezuclastinib

Updated ·next FDA decision on the calendar
FDA decision (PDUFA) target 2026-12-30 · Cogent Biosciences Inc. · Non-Advanced Systemic Mastocytosis
More Cancer & Oncology FDA decisions →All December 2026 PDUFA dates →

The story

Bezuclastinib is under FDA review to treat Non-Advanced Systemic Mastocytosis. Balance sheet: about 36 months of cash, runway into 2028 (company-guided).
Full PDUFA calendar ->Every upcoming FDA decision date, by monthLNTH-lnth-2501 . 2026-06-29Same area: Oncology . LNTH-2501 (Gallium-68 edotreotide)AZN-truqap . 2026-06-30Same area: Oncology . TruqapEXEL . 2026-12-03Same month decision . XL092 with atezolizumab
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

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% (763-PDUFA cohort, 2024-26). This is historical context by market-cap tier, not a prediction for this drug.
Decision-day move · mid-cap cohortn=222 · median -0.0% · 49% up
under -30%: 5 of 222 (2%)<-30-30 to -15%: 6 of 222 (3%)-15 to -7%: 7 of 222 (3%)-7 to -3%: 21 of 222 (9%)-3 to +3%: 134 of 222 (60%)±3+3 to +7%: 34 of 222 (15%)+7 to +15%: 9 of 222 (4%)+15 to +30%: 1 of 222 (0%)over +30%: 5 of 222 (2%)>+30
Distribution of next-day % moves after the FDA decision for mid-cap PDUFAs (2020–26). Red = down, green = up, blue = flat (±3%). Historical dispersion, not a forecast.