What upcoming FDA catalysts are there in Cardiovascular?

pdufa.bio tracks 12 upcoming Cardiovascular catalysts (1 PDUFA decisions, 11 trial readouts), each with a date and a primary-source link.

Does pdufa.bio predict whether these will be approved?

No. We do not publish per-drug approval probabilities; we show verified facts, primary-source links, and historical base rates so you can judge for yourself.

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Home › Condition › Cardiovascular

Upcoming Cardiovascular FDA decisions & readouts

Updated August 7, 2026·next 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.

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

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.