Market reactionShares fell 13% on Nov 5.
Black Diamond Therapeutics is a clinical-stage company developing silevertinib, a brain-penetrant EGFR inhibitor for lung cancer and glioblastoma; it is not yet approved.
Black Diamond's case rests on silevertinib, a brain-penetrant EGFR inhibitor. In 43 untreated lung cancer patients with non-classical EGFR mutations, 60% responded and preliminary median progression-free survival was 15.2 months; 86% of those with brain metastases had brain responses. The company had aimed to start pivotal development in the first half of 2026; it now expects FDA feedback in the fourth quarter. A glioblastoma trial starts its randomized part then. Cash of $110.5 million lasts into the second half of 2028.
Thesis checklist
0 risks need attention
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Next decision point
Tests: FDA agrees a pivotal path
Does FDA agree to a pivotal design that Black Diamond can run with its current cash?
Strong, inconclusive and weak outcomes
What to look for in the result and how each would move the checklist
Price and material events
Select an event marker to read the update below. Marker colors show Thesis status.
Black Diamond awaits FDA feedback on a pivotal path for silevertinib in lung cancer
Silevertinib's 60% ORR and 15.2-month mPFS in non-classical EGFRm NSCLC hinges on FDA alignment on a pivotal path in H2 2026
BDTX-1535's 60% ORR in non-classical EGFRm NSCLC must replicate at pivotal scale to validate the thesis against amivantamab and zipalertinib
About this history: every entry shows when the Thesis moved and what it said. The reasoning behind each move (the evidence, the analysis and the source filing) and the earnings write-ups are part of a subscription.
Dates, trials and completed outcomes are open to everyone. What each upcoming milestone hinges on is part of a subscription.
Disease areas: Lung cancer, Other cancers
Catalyst calendar · Upcoming FDA decisions · Thesis changes
Competitive landscape
9 peers tracked
Cash: Market-data provider estimate; measurement period unavailable.
Debt: Market-data provider estimate; a complete comparable filing balance is unavailable.
Quarterly burn: Estimated from trailing free cash flow; measurement period unavailable.
Net cash and estimated runway require verified matching measurement periods. Missing debt components are not assumed to be zero.
Runway: No underlying guidance available.