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pdufa.bio

Iptacopan

Updated ยทnext FDA decision on the calendar

Iptacopan is a Novartis Ag program. Its next catalyst is a Readout in Apr 2027. 1 FDA decision on record below. Every date links its source.

NVS catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Iptacopan is marketed as Fabhalta (iptacopan); the events below include those tracked under the brand name. Sponsor: Novartis Ag (NVS). 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 · Mar 20, 2025 ✓ ApprovedNVSReadout · Apr 2027NVS

Questions

When is Iptacopan's next FDA decision or readout?

The next tracked catalyst for Iptacopan is a Readout in Apr 2027.

What happened at Iptacopan's most recent FDA decision?

On Mar 20, 2025 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Who makes Iptacopan?

Novartis Ag (NVS).

Has Iptacopan been approved by the FDA?

Yes. The FDA approved an application for Iptacopan on Mar 20, 2025; 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.