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Rusfertide

Updated ยทnext FDA decision on the calendar

Rusfertide is a Protagonist Therapeutics Inc. program in Polycythemia vera. The FDA approved it on Aug 28, 2026. 1 FDA decision on record below. Every date links its source.

PTGX catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Rusfertide is marketed as MIMRYLO (rusfertide); the events below include those tracked under the brand name. Indication under review: Polycythemia vera. Sponsor: Protagonist Therapeutics Inc. (PTGX). Market-cap tier at the time we tracked it: Mid. We track 2 catalyst events for this program: 0 upcoming and 2 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 · Aug 28, 2026 ✓ ApprovedPTGXPDUFA · Q3 2026PTGX

Questions

When is Rusfertide's next FDA decision or readout?

No upcoming catalyst is on our calendar for Rusfertide; 1 FDA decision is on record below.

What happened at Rusfertide's most recent FDA decision?

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

What is Rusfertide used for?

In our records Rusfertide is under review or in development for Polycythemia vera.

Who makes Rusfertide?

Protagonist Therapeutics Inc. (PTGX).

Has Rusfertide been approved by the FDA?

Yes. The FDA approved an application for Rusfertide on Aug 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.