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Black Diamond Therapeutics Reports Updated Phase 2 Silevertinib Data, FDA End-Of-Phase 2 Feedback, Supporting Pivotal Development In All 1L EGFR-NCM NSCLC Patients With Potential For Accelerated Approval Based On CNS-ORR
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  • Updated Phase 2 results demonstrate robust CNS activity, including 86% CNS-ORR and mPFS double that of currently available EGFR TKIs, in patients with untreated brain metastases
  • Recent End-of-Phase 2 meeting with the FDA supports pivotal development in all 1L EGFR-NCM NSCLC patients with potential for accelerated approval based on CNS-ORR
  • Cash, cash equivalents, and investments of $102.0 million as of September 30, 2026, is expected to be sufficient to fund operations into the second half of 2028
  • Company to host an investor call today at 7:30am ET and will also participate in a fireside chat at the Stifel 2026 Healthcare Conference at 3:20pm ET

Black Diamond Therapeutics, Inc. (NASDAQ:BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, including silevertinib, a potential best-in-class brain-penetrant epidermal growth factor receptor (EGFR) inhibitor, today reported updated data from its Phase 2 trial of silevertinib in frontline non-small cell lung cancer (NSCLC) patients with EGFR non-classical mutations (NCMs), the outcome from its End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) and associated Phase 3 plans, and financial results for the third quarter ended September 30, 2026.

Disclaimer:This article represents the opinion of the author only. It does not represent the opinion of Webull, nor should it be viewed as an indication that Webull either agrees with or confirms the truthfulness or accuracy of the information. It should not be considered as investment advice from Webull or anyone else, nor should it be used as the basis of any investment decision.
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