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ASND FDA Decision Approved · 2026-02-28

Page updated ·next FDA decision on the calendar ·Data as of Oct 14, 2026 7:39 PM ET

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)
See the full 2026 PDUFA calendar →

Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.

Specialist biotech funds holding ASND, 13F for the quarter ended June 30, 2026

FundSharesValue at quarter endFiling
RA Capital Management10,281,496$2.74 billionfiled August 14, 2026
Perceptive Advisors1,163,721$310.4 millionfiled August 14, 2026
OrbiMed Advisors244,456$65.2 millionfiled August 14, 2026
Cormorant Asset Management50,000$13.3 millionfiled August 14, 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 TransCon CNP (navepegritide) approved by the FDA?

Yes. The FDA approved the application for TransCon CNP (navepegritide) on February 27, 2026, per the FDA's own record. The company announced it 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.