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# Fast Track for Secretome Heart Failure Drug
- URL: https://www.fdaweb.com/fast-track-for-secretome-heart-failure-drug/
- Published: 2025-03-24T12:00:00.000Z
- Updated: 2026-09-14T14:56:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158879

FDA has granted Secretome Therapeutics a fast track designation for STM-01, the company’s neonatal cardiac progenitor cell therapy for treating heart failure with preserved ejection fraction (HFpEF). The debilitating condition affects millions of patients worldwide, characterized by impaired heart relaxation and elevated left ventricular filling pressure despite a normal or near-normal ejection fraction, according to the company. “With limited disease-modifying treatments available, HFpEF remains a significant unmet medical need in cardiovascular medicine,” it says.

The designation is based on data from preclinical studies that have demonstrated STM-01 has the potential to reduce inflammation, inhibit fibrosis, and support cardiac tissue repair, Secretome says. A Phase 1 clinical trial will should be launched soon to evaluate safety and preliminary efficacy of STM-01 in HFpEF, it adds.