Upcoming Cardiovascular FDA decisions & readouts

PDUFA target dates and trial readouts in cardiovascular disease, each linked to its primary source. Updated from FDA/SEC/ClinicalTrials.gov; dates can shift.

Cancer & Oncology Obesity & Metabolic CNS & Neurology Immunology & Inflammation Rare Disease Infectious Disease & Vaccines Hematology

PDUFA decisions (1)

MLYS · 2026-12-22

lorundrostat Dose 1 — Hypertension

Trial readouts (11)

TENX · Oct 2026 (est.)

TNX-103 — Pulmonary Hypertension

TECX · Oct 2026 (est.)

TX000045- Dose A — Pulmonary Hypertension

ILMN · Oct 2026 (est.)

18F-MFBG — Heart Failure

BCDA · Dec 2026 (est.)

Autologous cell therapy — Heart Failure, Systolic

GOSS · Dec 2026 (est.)

Seralutinib — Pulmonary Arterial Hypertension

KARD · Dec 2026 (est.)

danicamtiv — Hypertension

INSM · Dec 2026 (est.)

Treprostinil Palmitil Inhalation Powder — Pulmonary Arterial Hypertension

MLYS · 2026-Q1

lorundrostat Dose 1 — Hypertension

CRSP · Jun 2027 (est.)

CTX001 — Cardiovascular

CYTK · Sep 2027 (est.)

Omecamtiv Mecarbil — Heart Failure

GOSS · Dec 2027 (est.)

Seralutinib — Pulmonary Arterial Hypertension

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