HYRNUO (sevabertinib) is a Bayer program in locally advanced or metastatic non-squamous NSCLC with HER2 (ERBB2) tyrosine kinase domain activating mutations (accelerated approval). The FDA approved it on Sep 9, 2026. 2 FDA decisions on record below. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
FDA approval tracked on pdufa.bio: locally advanced or metastatic non-squamous NSCLC with HER2 (ERBB2) tyrosine kinase domain activating mutations (accelerated approval) (approved Sep 9, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Sponsor: Bayer (BAYRY). Approval record: The FDA granted accelerated approval to HYRNUO (sevabertinib) on September 9, 2026 for adults with locally advanced or metastatic non-squamous NSCLC whose tumours carry HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorised test. Sevabertinib's original NDA was approved on November 19, 2025, so this decision expands an already-marketed drug rather than introducing a new one. We do not state how early the decision was, because the goal date we had carried was never sourced. Market-cap tier at the time we tracked it: Large. 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.
No upcoming catalyst is on our calendar for HYRNUO (sevabertinib); 2 FDA decisions are on record below.
On Sep 9, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
In our records HYRNUO (sevabertinib) is FDA-approved for locally advanced or metastatic non-squamous NSCLC with HER2 (ERBB2) tyrosine kinase domain activating mutations (accelerated approval) (approved Sep 9, 2026). Other approved uses may not be tracked here; the FDA label is the full record.
Bayer (BAYRY).
Yes. The FDA approved an application for HYRNUO (sevabertinib) on Sep 9, 2026; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.