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FDA grants fast track designation for HAYA Therapeutics’ HTX-001
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Pharmaceutical Business review
HAYA Therapeutics has secured fast track designation from the US Food and Drug Administration (FDA) for its investigational therapy, HTX-001, to treat symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).
Targeting long non-coding ribonucleic acid (lncRNA), HTX-001 is being evaluated in a Phase Ia/b clinical trial.
This regulatory designation recognises the potential of HTX-001 to offer a differentiated therapeutic approach for patients with nHCM.”
HAYA Therapeutics chief medical officer Jordan Shin said: “Patients with non-obstructive HCM are seeking treatments that go beyond management of symptoms.
In May 2025, Haya Therapeutics procured $65m in Series A funding to expedite the clinical development of HTX-001 for treating heart failure.