Ascendis Pharma A/S said the U.S. Food and Drug Administration granted accelerated approval for YUVIWEL (navepegritide), a once-weekly treatment indicated to increase linear growth in children aged 2 years and older with achondroplasia with open epiphyses. The company said continued approval may be contingent on confirmatory trials, and that the FDA also issued a Rare Pediatric Disease Priority Review Voucher in connection with the approval. Ascendis expects commercial availability in the United States in the early part of the second quarter of 2026.

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