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Cyllene Therapeutics Receives U.S. FDA Regenerative Medicine Advanced Therapy (RMAT ...
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Fusion42 · 14 September 2026 · Fusion42 review
Cyllene Therapeutics received FDA RMAT designation for EG110A, a novel gene therapy targeting neurogenic detrusor overactivity, based on promising Phase 1b/2a trial results. This status expedites development and regulatory review, facilitating closer FDA interaction and potential accelerated approval pathways.
This Wire brief sits within Fusion42's coverage of Biotech.
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You have a limited window to engage with the FDA more closely and shape trial designs that could speed your gene therapy to market. This designation sharpens the competitive edge by enabling faster development and early market access in severe bladder disorder treatments.
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1 source · 14 Sep 2026
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