Black Diamond Updates Phase 2 Results and Sets FDA Conditions Ahead of Phase 3
Key Facts
Black Diamond Therapeutics announced an update on November 10, 2026, to Phase 2 results from its silevertinib trial in patients with non-small cell lung cancer with atypical EGFR mutations. The announcement included U.S. Food and Drug Administration feedback following an end-of-Phase 2 meeting, along with third-quarter financial results. The company said the agency’s feedback supports pivotal development of the drug, with potential pathways to accelerated and full approval. However, starting Phase 3 is contingent on providing sufficient safety data at the dose requested by the agency. The company therefore outlined a conditional next regulatory step, not approval of the drug or a confirmed start to the pivotal trial.
The end-of-Phase 2 meeting with the Food and Drug Administration was held on October 1, 2026. According to the company’s account of the meeting, potential accelerated approval could be based on the central nervous system response rate, measured using RANO-BM criteria. Potential full approval, meanwhile, is linked to assessing progression-free survival under RECIST v1.1 criteria. The company said the assessment would also include systemic response and overall survival. These remain potential regulatory pathways as described by the company, while moving to Phase 3 requires meeting the safety-data condition.
In an update on treatment safety and duration, the company said 18 patients remained on silevertinib, with the longest treatment duration among them reaching 26.2 months. It added that it had observed no new safety signals in the update. These figures put treatment continuity among the details of the announcement, alongside the proposed regulatory pathway. In May, the company had reported that 23 of 43 patients remained on treatment at the time, with the longest treatment duration reaching 23.5 months. It also said in that announcement that median follow-up was 11.2 months at the April 11, 2026, data cutoff, and that participants received a dose of 200 mg once daily.
In the earlier May results, the objective response rate was 60% and the disease control rate was 91%, while median progression-free survival was 15.2 months, according to the company. These figures are prior Phase 2 data, not new results reported in the November 10 update. The company’s chief medical officer said at the time that the initial median progression-free survival, in his description, exceeded historical data for available treatments. That assessment reflects the company’s view as stated in its May announcement. The trial data were scheduled to be presented at the American Society of Clinical Oncology annual meeting on May 30, 2026.
On the financial front, research and development expenses fell to $7.0 million in the third quarter of 2026 from $7.4 million in the same period of 2025. The company attributed the decline mainly to the progress of the Phase 2 lung cancer trial, partially offset by costs to start and conduct a glioblastoma trial. General and administrative expenses, meanwhile, rose to $5.1 million from $3.5 million in the third quarter of 2025. The company attributed the increase to intellectual property-related costs and higher non-income taxes. The comparison puts the year-over-year decline in research spending alongside an increase in administrative expenses.
The company said its current cash position is expected, in its estimates, to fund operating and investing expenses through the second half of 2028. On August 5, it had disclosed $110.5 million in cash, cash equivalents and investments as of June 30, 2026, and then expected to fund operations through the second half of 2028. In that earlier update, the company expected to provide information on the trial and agency feedback on the pivotal development pathway during the fourth quarter of 2026. The company also said an investor call would be held on November 10, 2026, at 7:30 a.m. Eastern time. Ahead of the announcement, BDTX shares closed at $1.86 in the November 9 session, according to EL7 data.