Yeji
NDA/BLA filedconf 0.70

Bezuclastinib — NDA/BLA filed

$COGT · Cogent Biosciences, Inc. · Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors
Event date
Date TBD
Sponsor runway
8 mo
$241.2M liquid

Evidence

Based on these top-line data, Cogent expects to submit a new drug application ("NDA") to the U.S. Food and Drug Administration ("FDA") for bezuclastinib in AdvSM during the first half of 2026.
Source: 8-K filed 2025-12-08View on EDGAR ↗0001193125-25-311217

Comparable historical nda/bla fileds· last 5 years · same event type

TickerDrugDateOutcome
$AXSM2025-12-31unknown
$RCKTkresladi2025-10-14unknown
$ALDXreproxalap2025-07-17unknown
$ETONet-6002025-07-08unknown
$BCRXorladeyo (berotralstat)2025-05-14unknown
$CORTrelacorilant2025-03-03unknown
$ALDXreproxalap2024-11-01unknown
$AXSMaxs-072024-09-04unknown
$RCKTkresladi2023-10-02unknown
$GERNimetelstat2023-08-21unknown

Recent insider activity· ±90 days

3 insiders · 0 buys · 1 sells
Gift
2026-05-19
Robbins Andrew R
President and CEO
160,000 @
Grant
2026-04-01
Ferrante Karen Jean
Director
686 @
Conv
2026-03-31
Fairmount Funds Management LLC
Director
7,000,000 @
Sell
2026-03-31
Fairmount Funds Management LLC
Director
7,000,000 @ $34.66$242.62M
Conv
2026-03-31
Fairmount Funds Management LLC
Director
28,000 @