Ascendis Pharma A/S (ASND), a biopharmaceutical company, announced that its lead asset, YUVIWEL or Navepegritide, in the treatment of Achondroplasia in children aged two years and older, has been granted orphan drug exclusivity by the U.S. Food and Drug Administration FDA and is now commercially available in the United States.
The orphan drug exclusivity granted to YUVIWEL will run through February 27, 2033, a protected window to build revenue and patient adoption before similar products might enter the market.
Achondroplasia is a rare genetic condition causing skeletal dysplasia and, for many affected individuals, an increased risk of muscular, neurological, and cardiorespiratory complications.
YUVIWEL is a prodrug of C-type natriuretic peptide and was approved by the FDA on February 27, 2026, under the agency's Accelerated Approval Program to increase linear growth in children 2 years and older with achondroplasia and open growth plates (epiphyses) based on improvement in annualised growth velocity (AGV).
YUVIWEL is the first and only once-weekly treatment approved by the FDA to increase linear growth in children 2 years of age and older with achondroplasia and open epiphyses.
Meanwhile, continued approval for this indication may depend on verification and description of clinical benefit in confirmatory trials, according to the firm.
"We're excited to see the FDA grant orphan drug exclusivity for YUVIWEL, acknowledging it as a highly differentiated treatment option," said Jan Mikkelsen, President and Chief Executive Officer of Ascendis Pharma.
ASND has traded between $124.06 and $248.60 in the last year. The stock closed Monday's trade at $226.69, down 1.12%.
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