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Upcoming Hematology FDA decisions & readouts

Updated ยทnext FDA decision on the calendar
PDUFA target dates and trial readouts in hematology, each linked to its primary source. Updated from FDA/SEC/ClinicalTrials.gov; dates can shift.
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PDUFA decisions (2)

AGIO · 2026-11-01
Mitapivat (PYRUKYND) - (RISE UP): Sickle cell disease (sNDA)
NVO · 2026-12-31
Mim8 (denecimig): Hemophilia A prophylaxis, with or without inhibitors

Trial readouts (15)

CCCC · Sep 2026 (est.)
Cemsidomide
CGEM · Sep 2026 (est.)
CLN-081
KPTI · Sep 2026 (est.)
Selinexor
BYSI · Nov 2026 (est.)
Plinabulin
ONC · Nov 2026 (est.)
BGB-11417
BEAM · Dec 2026 (est.)
BEAM-302
JAZZ · Dec 2026 (est.)
CPX-351
KPTI · Dec 2026 (est.)
Selinexor
PFE · Dec 2026 (est.)
Elranatamab
BMY · Jan 2027 (est.)
Nivolumab
REGN · Jan 2027 (est.)
Odronextamab
AZN · Feb 2027 (est.)
R-Chop
ONC · Mar 2027 (est.)
Zanubrutinib
KPTI · Apr 2027 (est.)
Selinexor
JAZZ · Jun 2027 (est.)
CPX-351

Every upcoming FDA decision date, all therapeutic areas, on the 2026 PDUFA calendar · all conditions

We don't show an approval percentage for these hematology catalysts: here's why.