FDA Grants Rare Pediatric Disease Designation to Atossa Therapeutics' (Z)-Endoxifen for Duchenne Muscular Dystrophy

Reuters12-11

FDA Grants Rare Pediatric Disease Designation to Atossa <a href="https://laohu8.com/S/LENZ">Therapeutics</a>' <a href="https://laohu8.com/S/Z">$(Z)$</a>-Endoxifen for Duchenne Muscular Dystrophy

Atossa Therapeutics Inc. has received Rare Pediatric Disease $(RPD)$ designation from the U.S. Food and Drug Administration (FDA) for its drug candidate (Z)-Endoxifen for the treatment of Duchenne Muscular Dystrophy (DMD). This regulatory milestone may qualify Atossa for a Priority Review Voucher upon future approval, which could be used for expedited FDA review of another application or sold to another company. The designation recognizes (Z)-Endoxifen's potential as a treatment for DMD, a severe childhood neuromuscular disease, and highlights its differentiated mechanism that does not target specific exon defects, potentially broadening its applicability among patients. No other organizations were mentioned as recipients of this regulatory designation.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Atossa Therapeutics Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: SF44331) on December 11, 2025, and is solely responsible for the information contained therein.

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