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pdufa.bio

Rilzabrutinib

Updated ยทnext FDA decision on the calendar

Rilzabrutinib is a Sanofi program. Its next catalyst is a Readout in Nov 2026. 1 FDA decision on record below. Every date links its source.

SNY catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Rilzabrutinib is marketed as Wayrilz (rilzabrutinib); the events below include those tracked under the brand name. Sponsor: Sanofi (SNY). We track 3 catalyst events for this program: 2 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 · Aug 29, 2025 ✓ ApprovedSNYReadout · Nov 2026SNYReadout · Dec 2026SNY

Questions

When is Rilzabrutinib's next FDA decision or readout?

The next tracked catalyst for Rilzabrutinib is a Readout in Nov 2026.

What happened at Rilzabrutinib's most recent FDA decision?

On Aug 29, 2025 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Who makes Rilzabrutinib?

Sanofi (SNY).

Has Rilzabrutinib been approved by the FDA?

Yes. The FDA approved an application for Rilzabrutinib on Aug 29, 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.