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Black Diamond Therapeutics to Host Webcast Highlighting Updated Silevertinib Phase 2 Data and FDA Feedback Supporting a Clear Phase 3 Path to Potential Accelerated Approval in 1L EGFR-NCM NSCLC

Key Takeaway: Black Diamond Therapeutics will host a webcast on November 10, 2026, to present updated Phase 2 trial results for silevertinib in EGFR mutated non-small cell lung cancer. The FDA has provided feedback indicating a clear path to Phase 3 and potential accelerated approval. Silevertinib is designed to target multiple EGFR mutations effectively.

Market Sentiment Analysis

POSITIVE FACTORS

  • Updated Phase 2 data shows promise for silevertinib.
  • FDA feedback supports a clear path to Phase 3.
  • Silevertinib targets over 50 EGFR mutations.
  • Over 200 patients have been treated with silevertinib.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+77%
120-day peak, hindsight
Typical move
14.1%
average across 4 past catalysts
Cash runway
~38 mo
Minimal dilution risk
Lead asset
Silevertinib
Phase 2 · Non-Small Cell Lung Cancer

Full Press Release Details

Webcast will be held Tuesday, November 10, 2026, at 7:30 a.m. ET
CAMBRIDGE, Mass., Nov. 09, 2026 (GLOBE NEWSWIRE) -- 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, will host a webcast for investors to present updated results from its ongoing Phase 2 trial of silevertinib in frontline patients with EGFR mutated non-small cell lung cancer and FDA feedback supporting a clear Phase 3 path to potential accelerated approval in that patient population on Tuesday, November 10, 2026, at 7:30 a.m. ET.

Webcast information

The webcast can be accessed under “Events and Presentations” on the Investors section of the Black Diamond website at www.blackdiamondtherapeutics.com. A replay of the webcast will be available following the completion of the event for a limited time.

About Silevertinib

Silevertinib is an investigational oral, covalent, brain-penetrant fourth-generation tyrosine kinase inhibitor (TKI) that selectively targets classical and more than 50 non-classical EGFR mutations in NSCLC. It is also designed to potently inhibit key EGFR alterations seen in GBM, including EGFRvIII, while avoiding the paradoxical EGFR activation reported with reversible TKIs. To date, over 200 patients with EGFRm NSCLC or EGFR-altered GBM have been treated with silevertinib.
In addition to the ongoing Phase 2 trial of silevertinib in patients with non-classical EGFRm NSCLC, the Company is also conducting a randomized Phase 2 trial of silevertinib in patients with newly diagnosed EGFRvIII-positive GBM (NCT07326566).

About Black Diamond Therapeutics

Black Diamond Therapeutics is a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer. The Company’s MasterKey therapies are designed to address a broad spectrum of genetically defined tumors, overcome resistance, minimize wild-type mediated toxicities, and be brain penetrant to treat central nervous system disease. The Company is advancing silevertinib, an investigational brain-penetrant fourth-generation EGFR MasterKey inhibitor targeting EGFR-mutant NSCLC and GBM. For more information, please visit www.blackdiamondtherapeutics.com.

Frequently Asked Questions

What is the date of the Black Diamond webcast?

The webcast is scheduled for November 10, 2026.

What will be discussed in the webcast?

The webcast will present updated Phase 2 trial results for silevertinib.

What is silevertinib designed to target?

Silevertinib targets over 50 EGFR mutations in NSCLC.

How many patients have been treated with silevertinib?

Over 200 patients with EGFRm NSCLC or EGFR-altered GBM have been treated.

Last updated: Nov 9, 2026