Black Diamond Therapeutics, Inc.

Black Diamond Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update

Black Diamond reported Q2 2026 financial results with a net loss of $9.9 million and cash, cash equivalents, and investments of $110.5 million, which is expected to fund operations into the second half of 2028. The company provided a corporate update highlighting positive Phase 2 data for silevertinib, which showed an 86% CNS objective response rate and no de novo brain metastases in frontline non-classical EGFRm NSCLC patients. Management selected a 150 mg once daily dose for pivotal development and anticipates providing an update on the Phase 2 trial and FDA feedback on a pivotal path in the fourth quarter of 2026.

•2mo ago

Black Diamond Therapeutics Announces Positive Phase 2 Results for Silevertinib in Frontline NSCLC Patients with EGFR Non-Classical Mutations

Black Diamond Therapeutics reported positive Phase 2 results for silevertinib in frontline NSCLC patients with EGFR non-classical mutations, showing a preliminary median progression-free survival of 15.2 months. The drug demonstrated robust central nervous system activity with an 86% objective response rate in brain metastases and no patients developing de novo brain metastases during the study. Overall response rate was 60% across a broad spectrum of mutations, including PACC, with a manageable safety profile that supports advancing to a pivotal trial.

•5mo ago

Black Diamond Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Update

Black Diamond Therapeutics reported Q1 2026 cash, cash equivalents, and investments of $118.3 million, which is expected to fund operations into the second half of 2028. The company highlighted the dosing of the first patient in the Phase 2 trial of silevertinib in combination with temozolomide for newly diagnosed EGFRvIII+ GBM. Additionally, management announced that updated Phase 2 data for silevertinib in frontline EGFRm NSCLC will be presented orally at the ASCO Annual Meeting on May 30.

•5mo ago

Black Diamond Therapeutics Announces Oral Presentation of Silevertinib Phase 2 Data in Frontline EGFRm NSCLC Patients at the 2026 ASCO Annual Meeting

Black Diamond Therapeutics announced that it will present Phase 2 data for silevertinib at the 2026 ASCO Annual Meeting, including an oral session on treatment-naïve NSCLC patients. Additional poster presentations will cover safety and efficacy results in previously treated NSCLC patients and a trial-in-progress update for newly diagnosed EGFRvIII-positive glioblastoma. The release reiterated initial data disclosed in December 2025, showing a 60% objective response rate, 86% CNS ORR, and 91% disease control rate in the frontline setting.

•6mo ago