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FDA & Clinical Calendar

FDA approval decisions and clinical trial milestones are different catalysts. Explore each calendar with its dates and linked evidence.

ON THE HORIZON

The next 30 days.

Dates, pipelines and official sources

FDA Calendar

Clinical readouts and trial milestones

Oct 12, 2026
EPRXEUPRAXIA PHARMACEUTICALS INC.EP-104GI
Conference presentation
Official source A ↗
Oct 14, 2026
ARWRARROWHEAD PHARMACEUTICALS, INC.ARO-MAPT
Interim clinical data
Official source B ↗
Oct 14, 2026
IRDOpus Genetics, Inc.OPGx-001
Phase 1/2 data
Official source B ↗
Oct 14, 2026
VSTMVerastem, Inc.VS-7375
Phase 1/2 data
Official source B ↗
Oct 15, 2026
ENGNenGene Therapeutics Inc.Detalimogene voraplasmid (EG-70)
Preclinical webinar · enrollment guidance
Official source B ↗
Oct 14-17, 2026
PHARPharming Group N.V.Joenja® (leniolisib)
Phase 2 data · Additional
Official source A ↗
Oct 18, 2026
EPRXEUPRAXIA PHARMACEUTICALS INC.EP-104GI
Conference presentation
Official source A ↗
Oct 19, 2026
EPRXEUPRAXIA PHARMACEUTICALS INC.EP-104GI
Conference presentation
Official source A ↗
Oct 20, 2026
ACHVAchieve Life Sciences, Inc.Cytisinicline
Phase 2 data
Official source B ↗
Oct 17-20, 2026
STTKShattuck Labs, Inc.SL-846
Preclinical data
Official source A ↗

PDUFA Calendar

U.S. FDA decision dates

Oct 26, 2026
IONSIonis Pharmaceuticals, Inc.bepirovirsen
Partner-led: GSK · US · Expected Regulatory
Official source A ↗
Oct 30, 2026
INOINOVIO PHARMACEUTICALS, INC.INO-3107
U.S. BLA decision
Official source B ↗
Nov 1, 2026
AGIOAGIOS PHARMACEUTICALS, INC.mitapivat (PYRUKYND)
U.S. sNDA decision
Official source B ↗