Stealth BioTherapeutics discloses FDA rejection letter in effort to rally support for rare disease drug

statnews.com/pharmalot/2025/08/18/stealth-biotherapeutics-barth-syndrome-fda-rejection-letter

In a highly unusual move, a small biotech company has disclosed a rejection letter from the Food and Drug Administration in hopes of rallying support for regulatory approval of an ultra-rare disease drug.
The step is part of a campaign being pursued by Stealth BioTherapeutics in light of…

This story appeared on statnews.com, 2025-08-18 18:29:08.818000.
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