BAYRY FDA decision: Sep 9, 2026

HYRNUO (sevabertinib) - HER2-mutant NSCLC was approved by the FDA on September 9, 2026 for locally advanced or metastatic non-squamous NSCLC with HER2 (ERBB2) tyrosine kinase domain activating mutations (accelerated approval).

Verified against: FDA action day September 9, 2026 (NDA 219972 S-001) · Announcement September 9, 2026 (sponsor announcement) · Goal date none sourced.

HYRNUO (sevabertinib) granted accelerated approval for locally advanced or metastatic non-squamous NSCLC with HER2 (ERBB2) tyrosine kinase domain activating mutations (Sep 9 2026).

Run-up into the decision (T-120 → T+5)

Key facts

This page states no earliness figure, deliberately. We had carried a goal date of November 30, 2026 for this application and it was never sourced: no Bayer filing or release states it, and Bayer is not an SEC registrant, so there is no filing to check. The FDA's own approval letter for NDA 219972/S-001 shows the supplemental application was received on March 16, 2026, which under priority review points to September rather than November. What is certain is the FDA's action: accelerated approval effective September 9, 2026. Sevabertinib's original NDA was approved on November 19, 2025, so this decision expands the label of a drug already on the market.

Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.

Primary source: FDA approval letter, NDA 219972/S-001, September 9, 2026

FDA record of the action: the FDA approved on September 9, 2026, per NDA 219972 S-001 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.