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

Black Diamond Therapeutics (BDTX) will host an investor webcast on November 10, 2026, to discuss silevertinib clinical results and FDA feedback.

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Rhea-AI Summary

Black Diamond Therapeutics (BDTX) will host an investor webcast on November 10, 2026, to discuss silevertinib clinical results and FDA feedback. The webcast begins at 7:30 a.m. ET and will cover updated results from the ongoing Phase 2 trial in frontline patients with EGFR-mutated non-small cell lung cancer. The company describes the FDA feedback as supporting a Phase 3 path to potential accelerated approval in that population.

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Details

Market move: BDTX +7.78% vs previous close. Phase 2 data webcast

+3.5% Peak in 0 min

$1.73 – $1.91 Day Range

$107.44M Mkt Cap at Last Price

On Nov 9, the day this news came out, the latest delayed price for BDTX is 7.78% above the previous close. Argus tracked a peak move of +3.5% during the session. Our momentum scanner has recorded 21 alerts for this stock so far that day. The latest delayed price is $1.87.

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Key Terms

non-small cell lung cancer, accelerated approval

2 terms

non-small cell lung cancer medical

"frontline patients with EGFR mutated non-small cell lung cancer"

A broad category of lung tumors that grow from the cells lining the airways and make up the majority of lung cancer cases; it includes several subtypes that behave and respond to treatment differently, like different models of the same car family. It matters to investors because its large patient population and variety of treatment options — surgery, traditional chemo, targeted drugs and immunotherapies — create major markets where clinical trial results, drug approvals or changing treatment guidelines can quickly affect a company’s revenue and stock value.

accelerated approval regulatory

"clear Phase 3 path to potential accelerated approval"

Accelerated approval is a process that allows new medical treatments to be approved more quickly than usual if they address serious or life-threatening conditions and show promising early results. For investors, it signals that a treatment may reach the market sooner, potentially boosting a company's prospects, but it also involves some uncertainty since full evidence of effectiveness is still being gathered.

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11/09/2026 - 04:01 PM EST

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.

Contacts

For Investors:
investors@bdtx.com

For Media:
media@bdtx.com