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)
Daily close, T-120 (3/16/26) through T+0. Run-up high $15.19 on 7/2/26, low $9.88 on 6/2/26 (T-120 to T-1). FDA decision 9/9/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-09-09
OutcomeApproved
Drug / candidateHYRNUO (sevabertinib)
IndicationHER2-mutant non-small cell lung cancer
CompanyBayer
Market-cap tierLarge
120-day run-up (T-120→T-1)+24.6%
Cohort decision-day move (history)1.0% median (n=834)
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.
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