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Brepocitinib

Updated ยทnext FDA decision on the calendar

Brepocitinib is a Roivant Sciences Ltd., Roivant/Priovant program in Dermatomyositis. Its next catalyst is a Readout in Sep 2026. 2 FDA decisions on record below. Every date links its source.

PFE catalyst hub · ROIV catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Brepocitinib is marketed as LISRAYA (brepocitinib); the events below include those tracked under the brand name. Indications under review: Dermatomyositis; Dermatomyositis (DM). Sponsor: Roivant Sciences Ltd., Roivant/Priovant (PFE, ROIV). Market-cap tier at the time we tracked it: Large. We track 5 catalyst events for this program: 1 upcoming and 4 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 27, 2026 ✓ ApprovedPFEPDUFA · Aug 27, 2026 ✓ ApprovedROIVPDUFA · Q3 2026PFEPDUFA · Q3 2026ROIVReadout · Sep 2026ROIV

Questions

When is Brepocitinib's next FDA decision or readout?

The next tracked catalyst for Brepocitinib is a Readout in Sep 2026.

What happened at Brepocitinib's most recent FDA decision?

On Aug 27, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

What is Brepocitinib used for?

In our records Brepocitinib is under review or in development for Dermatomyositis; Dermatomyositis (DM).

Who makes Brepocitinib?

Roivant Sciences Ltd., Roivant/Priovant (PFE, ROIV).

Has Brepocitinib been approved by the FDA?

Yes. The FDA approved an application for Brepocitinib on Aug 27, 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.