BlossomHill settles BH-30643 dose with FDA, setting up lung cancer registrational study

BlossomHill Therapeutics has reached agreement with US regulators on the dose it will take into late-stage testing of BH-30643, its treatment for non-small cell lung cancer driven by the EGFR C797S mutation. The company said on 12 November 2026, with its third-quarter results, that the FDA aligned on 50 mg taken twice a day as the recommended Phase 2 dose.

That decision allows BlossomHill to move on to SOLARA-2, a single-arm pivotal trial. The company says the study could underpin an accelerated approval application, and it expects to enrol its first patient in the first quarter of 2027. The announcement does not say the FDA has agreed that a single-arm design would be enough for approval, so the filing route remains the company's aim rather than a confirmed pathway.

Because the drug is aimed at a biomarker-defined group, BlossomHill is also working with Foundation Medicine on a companion diagnostic to identify patients with the C797S mutation. The test will therefore be part of the development plan alongside the trial itself.

The company reported cash of $224.9 million at the end of the quarter. In August 2026 it raised $168.3 million gross in an initial public offering. BlossomHill expects that money to fund operations into the second quarter of 2028, a horizon that includes the planned start of SOLARA-2.

Context: accelerated approval is an FDA route that allows medicines for serious conditions to be cleared on a surrogate or intermediate endpoint, normally with confirmatory evidence required after approval.