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Upcoming Cardiovascular FDA decisions & readouts

Updated ยทnext FDA decision on the calendar
PDUFA target dates and trial readouts in cardiovascular, each linked to its primary source. Updated from FDA/SEC/ClinicalTrials.gov; dates can shift.
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PDUFA decisions (1)

MLYS · 2026-12-22
lorundrostat Dose 1: Hypertension

Trial readouts (6)

BCDA · Dec 2026 (est.)
Autologous cell therapy
GOSS · Dec 2026 (est.)
Seralutinib
INSM · Dec 2026 (est.)
Treprostinil Palmitil Inhalation Powder
LXEO · Dec 2026 (est.)
LX1001
LXRX · Jan 2027 (est.)
Sotagliflozin
GOSS · Dec 2027 (est.)
Seralutinib

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

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