Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED
YUVIWEL (navepegritide) was approved by the FDA on February 27, 2026 to increase linear growth in pediatric patients 2 years and older with achondroplasia with open epiphyses, the 5th novel drug approval of 2026 on the FDA's Novel Drug Approvals list.
Daily close, T-120 (9/12/25) through T+5. Run-up high $238.8 on 1/28/26, low $189.74 on 10/2/25 (T-120 to T-1). FDA decision 2/27/26. Historical price action, not a forecast.
FDA record of the action: the FDA approved on February 27, 2026, per NDA 219164 ORIG-1 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
Specialist biotech funds holding ASND, 13F for the quarter ended June 30, 2026
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Questions
Was YUVIWEL (navepegritide) approved by the FDA?
Yes. The FDA approved the application for YUVIWEL (navepegritide) on February 27, 2026, per the FDA's own record. The primary source is linked on this page.
Which company is behind YUVIWEL (navepegritide)?
YUVIWEL (navepegritide) is an Ascendis Pharma A/S (ASND) program. The FDA decision came on February 27, 2026; the FDA's own record of the decision is linked on this page.
How did ASND stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), ASND moved +11.2%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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