May 29, 2025 07:14 AM EDT

FDA rejects Stealth's rare disease drug, but offers potential for accelerated approval

Zachary Brennan

Senior Editor

After a slight delay, the FDA rejected Stealth BioTherapeutics’ Barth syndrome drug application for elamipretide, the company said early Thursday, but will consider a resubmission …

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FDA rejects Stealth's rare disease drug, but offers potential for accelerated approval

Zachary Brennan

Senior Editor

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VP, Clinical Development / CMO / CDO‬ ‭ (Stealth Portfolio Company)

Autonomy Bio Inc.

San Francisco, CA 94107, USA

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FDA re­jects Stealth's rare dis­ease drug, but of­fers po­ten­tial for ac­cel­er­at­ed ap­proval

Senior Editor

Sign up to read this article for free.

Autonomy Bio Inc.

San Francisco, CA 94107, USA

FDA rejects Stealth's rare disease drug, but offers potential for accelerated approval