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Home › FDA Decisions › ASND 2026-02-28

ASND FDA Decision Approved · 2026-02-28

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 2/28/26$238.8$189.749/12/25
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 2/28/26. Historical price action, not a forecast.

Decision facts

FDA decision date2026-02-28
DrugTransCon CNP (navepegritide)
IndicationAchondroplasia
Outcome✓ Approvedprimary-sourced
Decision-day move+3.7%
T-120 run-up (low→high)+19.0% ($196.01→$242.09)
ValidationVerified 2026-08-12: Drugs@FDA, application NDA219164, action date 2026-02-27
See the full 2026 PDUFA calendar →

Questions

Was TransCon CNP (navepegritide) approved by the FDA?

Yes. The FDA approved the application for TransCon CNP (navepegritide) on February 28, 2026. The primary source is linked on this page.

What was TransCon CNP (navepegritide) under FDA review for?

The application covered Achondroplasia. The FDA approved the application on February 28, 2026.

How did ASND stock react to the FDA decision?

On the decision day ASND moved +3.7%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.