PDUFA Calendar
Exact U.S. FDA action dates for NDA, sNDA, BLA, and sBLA applications, backed by official evidence.
FREE BETA · Guests can view 30 days, including today (through Nov 10, 2026, ET). Sign in for the full calendar.
3 of 33 scheduled catalysts · 3 of 30 companies with matching events
Evidence: A regulator/SEC/trial registry · B official company source · Market data is separate context.
Scheduled catalysts
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Next CatalystCompanyDrugPrice · 30DCurrent stage
Ionis Pharmaceuticals, Inc.IONS
Drugbepirovirsenantisense oligonucleotide
Indicationchronic hepatitis B
TargetHBV RNA
RegulatoryPartner-led: GSK · US · Expected RegulatoryOct 26, 2026US
PDUFA action date of October 26, 2026
AOfficial sourceAll sources (3)
Current stageRegulatory
PreINDP1P2P3FilingApproved
Price · 30D
$45.59-18.1%
30D · 10/09INOVIO PHARMACEUTICALS, INC.INO
DrugINO-3107DNA immunotherapy
IndicationRecurrent Respiratory Papillomatosis (RRP)
TargetHPV-6 / HPV-11
Current stageCurrent stage not confirmed
PreINDP1P2P3FilingApproved
Price · 30D
$1.10-14.5%
30D · 10/09AGIOS PHARMACEUTICALS, INC.AGIO
Drugmitapivat (PYRUKYND)small molecule
Indicationsickle cell disease
TargetPKR / PKM2
Current stageRegulatory
PreINDP1P2P3FilingApproved
Price · 30D
$31.90-5.2%
30D · 10/09