Black Diamond maps late-stage route for lung cancer drug, with a $102m cash buffer

Black Diamond Therapeutics has set out how it hopes to take silevertinib into pivotal testing, giving investors and potential partners a clearer view of the regulatory route and funding for its lead programme. The company's update, dated 10 November 2026, covers previously untreated non-small cell lung cancer driven by non-classical EGFR mutations.

According to the company, the US Food and Drug Administration's feedback followed an End-of-Phase 2 meeting on 1 October 2026. The proposed Phase 3 programme could support accelerated approval using the rate of tumour response in the central nervous system (CNS-ORR), with full approval resting on progression-free survival. Black Diamond intends to open a global Phase 3 study in the second quarter of 2027. The agency has asked for safety data at the 150 mg dose before that trial can begin, which makes it a gating item for the timetable.

On the updated Phase 2 data, Black Diamond reported a CNS-ORR of 86% in an evaluable subset of patients with untreated brain metastases. The summary available does not say how many patients are in that subset, nor does it give wider efficacy or safety results, so the figure should be read cautiously.

Black Diamond reported cash of $102.0 million and says this should fund operations into the second half of 2028. On the company's own projection, that period would include the planned Phase 3 start. The company has not, in the material available, said what the full Phase 3 programme will cost or whether it is seeking a partner.