FDA Gives Ascendis Pharma More Time: TransCon CNP Decision Pushed to Feb 2026

Ascendis Pharma (ASND) just got a three-month extension from the FDA on its blockbuster drug candidate TransCon CNP (Navepegritide) for pediatric achondroplasia. The new decision date is now February 28, 2026, instead of the original November 30, 2025 timeline.

Here’s why this matters: Achondroplasia affects over 250,000 people globally and causes not just short stature but serious complications—muscular, neurological, and cardiorespiratory issues. Currently, BioMarin’s Voxzogo is the only FDA-approved treatment, but it requires daily injections. That’s the pain point.

ASND’s drug flips the script—once-weekly dosing instead of daily. If it clears, that’s a massive convenience advantage in the pediatric market, potentially reshaping how doctors treat this rare genetic condition.

The FDA delay? They need more time to review post-marketing requirement data ASND submitted in November. Standard stuff for a complex rare disease indication, but it does push the approval timeline back.

Stock moves: ASND closed Tuesday at $206.65, down 2.38%. The share has been range-bound between $118-$223 over the past year—typical volatility for biotech plays awaiting regulatory decisions.

The February decision will be make-or-break for whether ASND can capture market share from BioMarin in this high-value niche segment.