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Black Diamond Therapeutics Announces Positive Updated Silevertinib Phase 2 Results, FDA Feedback Supporting a Clear Path to Potential Registration in 1L EGFR-NCM NSCLC, and Provides Corporate Update

BDTX
  • Updated Phase 2 results for silevertinib show 86% CNS-ORR in patients with untreated brain metastases & median progression-free survival (mPFS) double that of current EGFR TKIs.
  • An FDA End-of-Phase 2 meeting supported a pivotal development program for all first-line EGFR non-classical mutation NSCLC patients with a potential path to accelerated approval based on CNS-ORR.
  • Black Diamond Therapeutics holds $102.0 million in cash, cash equivalents, & investments as of September 30, 2026, expected to fund operations into the second half of 2028.
  • The company announced an investor call today at 7:30 am ET & participation in a fireside chat at the Stifel 2026 Healthcare Conference at 3:20 pm ET.
  • Phase 2 trial data as of October 7, 2026, showed 60% overall response rate, 93% disease control rate, & 15.0-month mPFS in 43 frontline NSCLC patients with EGFR non-classical mutations.
  • No new safety signals were observed, & no patients with baseline brain metastases developed de novo brain metastases during treatment.
  • Cohort 4 of the Phase 2 trial is enrolling at the planned pivotal dose of 150 mg once daily, with the first patient dosed in Q3 2026.
  • The FDA acknowledged 150 mg QD as the pivotal dose but requires safety data from sufficient patients in Cohort 4 prior to opening a Phase 3 trial.
  • A global Phase 3 registrational trial is planned for initiation in Q2 2027, enrolling 300 patients with untreated brain metastases randomized to silevertinib or physician's choice of osimertinib or afatinib.
  • The Phase 3 primary endpoints include CNS-ORR for potential accelerated approval & systemic PFS for potential full approval.
  • A separate randomized Phase 2 trial for newly diagnosed EGFRvIII+ glioblastoma is enrolling at 150 mg QD, with interim PFS data expected in the first half of 2028.
  • Q3 2026 financial results reported $10.0 million net loss, $7.0 million in R&D expenses, & $5.1 million in general & administrative expenses.
  • R&D expenses decreased compared to Q3 2025 due to trial progression, partially offset by increased spending for the GBM trial startup.
  • G&A expenses increased compared to Q3 2025 primarily due to higher IP-related costs & non-income tax expenses.
Company
Black Diamond Therapeutics, Inc
Keywords
Nasdaq:BDTX, Black Diamond Therapeutics, Inc