---
title: "HAYA Therapeutics SA receives FDA Fast Track designation in the U.S. for HTX-001; accelerates HTX-001 toward nHCM"
sdDatePublished: "2026-08-10T09:09:00Z"
source: "https://www.biopole.ch/haya-therapeutics-receives-fda-fast-track-designation-for-htx-001/"
topics:
  - name: "medical research"
    identifier: "medtop:20000737"
  - name: "biotechnology"
    identifier: "medtop:20000711"
locations:
  - "Lausanne"
---


HAYA Therapeutics SA receives FDA Fast Track designation in the U.S. for HTX-001; accelerates HTX-001 toward nHCM

HAYA Therapeutics Receives FDA Fast Track Designation for HTX-001 • Biopôle

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HAYA Therapeutics Receives FDA Fast Track Designation for HTX-001

HAYA Therapeutics SA, a clinical-stage biotechnology company pioneering precision RNA-guided therapeutics that target the regulatory genome to reprogram disease-driving cell states in common, chronic and age-related diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for HTX-001 for the treatment of symptomatic nonobstructive hypertrophic cardiomyopathy (nHCM). The first-in-class investigational long non-coding RNA (lncRNA)-targeting therapy is in a Phase 1a

b trial, with the first cohort dosed this past May.

HTX-001 is a differentiated, potentially disease-modifying antisense oligonucleotide engineered to downregulate WISPER , a heart stress-specific lncRNA that is overexpressed in hypertrophic cardiomyopathy, including nHCM. By targeting WISPER in cardiac myofibroblasts, HTX-001 is intended to promote the precision reprogramming of this fibrotic and pathological cell state toward a healthy phenotype.

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News > HAYA Therapeutics Receives FDA Fast Track Designation for HTX-001

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