pdufa.bio

TransCon CNP (navepegritide)

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET

TransCon CNP (navepegritide) is an Ascendis Pharma A/S program. Its next catalyst is a Readout in Aug 2027. 1 FDA decision on record below. Every date links its source.

ASND catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: Ascendis Pharma A/S (ASND). We track 2 catalyst events for this program: 1 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

FDA decision · Feb 28, 2026 ✓ ApprovedASNDReadout · Aug 2027ASND

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

When is TransCon CNP (navepegritide)'s next FDA decision or readout?

The next tracked catalyst for TransCon CNP (navepegritide) is a Readout in Aug 2027.

What happened at TransCon CNP (navepegritide)'s most recent FDA decision?

On Feb 28, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Who makes TransCon CNP (navepegritide)?

Ascendis Pharma A/S (ASND).

Has TransCon CNP (navepegritide) been approved by the FDA?

Yes. The FDA approved an application for TransCon CNP (navepegritide) on Feb 28, 2026; the decision page linked above carries the source.

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.