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pdufa.bio

TransCon CNP (navepegritide)

Updated ยทnext FDA decision on the calendar

TransCon CNP (navepegritide) is a 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

PDUFA · Feb 28, 2026 ✓ ApprovedASNDReadout · Aug 2027ASND

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.