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Black Diamond reports strong Phase 2 results for silevertinib in NSCLC, with FDA support for Phase 3 trial and potential accelerated approval.

Company Fundamentals
10 Nov 2026, 13:30 WIB
GlobeNewsWire
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Bullish
Black Diamond reports strong Phase 2 results for silevertinib in NSCLC, with FDA support for Phase 3 trial and potential accelerated approval.

Black Diamond Therapeutics announced positive updated Phase 2 results for silevertinib in frontline non-small cell lung cancer (NSCLC) patients with non-classical EGFR mutations, showing an 86% CNS objective response rate and median progression-free survival (mPFS) double that of current EGFR inhibitors. The FDA's End-of-Phase 2 meeting feedback supports a clear path to a pivotal Phase 3 trial and potential accelerated approval based on CNS response. The company plans to start a global Phase 3 trial in mid-2027, enrolling 300 patients with untreated brain metastases, comparing silevertinib to standard treatments. Black Diamond holds $102 million in cash, expected to fund operations into late 2028.

Black Diamond Therapeutics' recent Phase 2 update on silevertinib in NSCLC patients provides context for health sector investors. For readers following health stocks, here is Pluang's market snapshot as of Nov 10, 2026 17:51 WIB: out of 150 priced US health-sector stocks, 76 rose and 58 fell. Notable movers include TVTX at USD 50.50 with a -2.19% change and an 8-day typical hold time, ABEO at USD 2.59 up 1.97% with 71% buy order activity and a 24-day hold, and HIMS at USD 22.54 down 1.77% with 100% buy order activity and a 24-day hold.

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