(RTTNews) - Ascendis Pharma A/S (ASND), on Wednesday, reported that the FDA has extended the decision date for TransCon CNP, proposed for the treatment of children with achondroplasia, by three months to February 28, 2026.
Achondroplasia is a rare genetic condition that not only leads to skeletal dysplasia characterised by disproportionate short stature, but also causes serious muscular, neurological, and cardiorespiratory complications. More than 250,000 people worldwide are affected by this condition.
TransCon CNP, also known as Navepegritide, is an investigational prodrug of C-type natriuretic peptide (CNP), which is designed to be administered as once weekly subcutaneous injection. The initial FDA decision was scheduled for November 30, 2025, and it has been pushed back by three months as the FDA needs more time to evaluate the post-marketing requirement information the company submitted on November 5, 2025.
Voxzogo, developed by BioMarin Pharmaceutical Inc. (BMRN), is the first and only FDA-approved treatment for pediatric patients with achondroplasia and requires once-daily subcutaneous administration.
In contrast, Ascendis Pharma's TransCon CNP is designed to be administered as a once-weekly subcutaneous injection and, if approved, has the potential to provide an efficacious, safe, tolerable, and convenient treatment option.
Over the year, ASND shares were trading in a range of $118.03 to $223.18. On Tuesday the shares had closed 2.38% lower at $206.65.
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