pdufa.bio

HYRNUO (sevabertinib)

Updated ยทnext FDA decision on the calendar

HYRNUO (sevabertinib) 1 FDA decision on record below. Every date links its source.

BAYRY catalyst hub

About this program

We track 1 catalyst event for this program: 0 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 · Nov 20, 2025 ✓ ApprovedBAYRY

Questions

When is HYRNUO (sevabertinib)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for HYRNUO (sevabertinib); 1 FDA decision is on record below.

What happened at HYRNUO (sevabertinib)'s most recent FDA decision?

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

Has HYRNUO (sevabertinib) been approved by the FDA?

Yes. The FDA approved an application for HYRNUO (sevabertinib) on Nov 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.