Welcome to our dedicated page for Black Diamond Therapeutics news (Ticker: BDTX), a resource for investors and traders seeking the latest updates and insights on Black Diamond Therapeutics stock.
Black Diamond Therapeutics reports clinical and corporate developments for a clinical-stage oncology business built around MasterKey therapies that target families of oncogenic mutations in cancer. Company news centers on silevertinib, a brain-penetrant fourth-generation EGFR MasterKey inhibitor, and its development in EGFR-mutant non-small cell lung cancer and glioblastoma.
Recurring updates include Phase 2 clinical data, medical meeting presentations, program expansion across NSCLC and GBM, financial results, cash runway commentary, partnership discussions and investor-conference participation. The company also describes its approach to genetically defined tumors, resistance mechanisms, wild-type mediated toxicities and central nervous system disease in program communications.
Black Diamond Therapeutics (Nasdaq: BDTX) reported Q2 2026 results and clinical progress for silevertinib. As of April 11, 2026, Phase 2 data in 43 frontline non-classical EGFR-mutant NSCLC patients showed an ORR of 60%, CNS ORR of 86%, disease control rate of 91%, preliminary median PFS of 15.2 months, and no de novo brain metastases. Median duration of response was not reached and 53% of patients remained on therapy, with the longest at 23.5 months. Grade ≥3 treatment-related adverse events fell to 28% after dose reduction, supporting a 150 mg QD pivotal dose. Black Diamond held $110.5 million in cash, cash equivalents, and investments on June 30, 2026, which it expects will fund operations into 2H 2028. Q2 2026 R&D expenses were $7.4 million, G&A expenses $4.7 million, and net loss $9.9 million.
Black Diamond Therapeutics (Nasdaq:BDTX) announced that CEO Mark Velleca, M.D., Ph.D., will join a fireside chat at the Jefferies Global Healthcare Conference in New York on June 3, 2026, from 4:55–5:25 p.m. ET. A live and archived webcast will be available.
Black Diamond Therapeutics (Nasdaq: BDTX) reported positive Phase 2 results for silevertinib in frontline NSCLC patients with EGFR non-classical mutations.
Key data include preliminary mPFS of 15.2 months, ORR of 60%, DCR of 91%, CNS ORR of 86%, and no de novo brain metastases observed.
Safety data showed a dose-dependent, manageable AE profile, supporting 150 mg once daily for pivotal development.
Black Diamond Therapeutics (Nasdaq: BDTX) will host an investor webcast on May 21, 2026 at 5:30 p.m. ET. The event will highlight updated results from the ongoing Phase 2 trial of silevertinib in frontline EGFR-mutated non-small cell lung cancer.
The webcast is accessible via the Investors & Events section of Black Diamond's website, with a replay available for a limited time.
Black Diamond Therapeutics (Nasdaq: BDTX) reported Q1 2026 results and a corporate update. The company reported $118.3M in cash, cash equivalents, and investments as of March 31, 2026, and expects this to fund operations into the 2H 2028. Clinical progress includes an oral ASCO presentation of Phase 2 silevertinib data (preliminary DOR and PFS) and dosing of the first patient in a randomized Phase 2 EGFRvIII+ GBM trial.
Black Diamond Therapeutics (Nasdaq: BDTX) announced multiple presentations of Phase 2 silevertinib (BDTX-1535) data at the 2026 ASCO Annual Meeting, May 29–June 2, 2026 in Chicago. An oral Rapid Abstract session on May 30, 2026 will feature frontline EGFRm NSCLC results; posters on May 31 and June 1 cover recurrent NSCLC and a randomized GBM trial.
Slides and posters will be made available on the company website at 8:00 AM EDT on the stated dates.
Black Diamond Therapeutics (Nasdaq: BDTX) reported Q4 and full-year 2025 results and a corporate update focused on silevertinib development.
Key metrics: cash, cash equivalents and investments of $128.7 million at 12/31/2025; net cash provided by operations $29.6 million for 2025; Phase 2 frontline NSCLC data showed 60% ORR, 86% CNS ORR, and 91% DCR (data cutoff Nov 3, 2025). Company expects updated Phase 2 data and a randomized GBM Phase 2 start in Q2 2026 and believes cash is sufficient into 2H 2028.
Black Diamond Therapeutics (Nasdaq: BDTX) announced management will present at three investor conferences in March and April 2026. Presenters include CEO Mark Velleca, M.D., Ph.D. and CSO Elizabeth Buck, Ph.D.
Scheduled presentations: TD Cowen Healthcare Conference on Mar 4, 2026 at 1:10pm ET, Needham Virtual Healthcare Conference on Apr 15, 2026 at 3:00pm ET, and investor meetings at Raymond James BioPharma on Apr 14, 2026. Webcasts and 90-day archived replays will be available via the company investor relations site.
Black Diamond Therapeutics (NASDAQ: BDTX) reported preliminary Phase 2 results for silevertinib in frontline (1L) NSCLC and announced plans for a randomized Phase 2 trial in newly diagnosed GBM.
Key 1L NSCLC data (n=43, data cutoff Nov 3, 2025): ORR 60%, CNS ORR 86%, DCR 91%; median follow-up 7.2 months; 29 patients remain on therapy. No new safety signals observed. PFS and DOR readouts expected Q2 2026.
GBM plan: randomized ~150-patient Phase 2 starting 1H 2026 (silevertinib + TMZ vs TMZ), primary endpoint PFS; preliminary GBM data expected 2028. Cash $135.5M as of Sept 30, 2025, expected to fund operations into 2H 2028.
Black Diamond Therapeutics (Nasdaq: BDTX) will host a live webcast on Wednesday, December 3, 2025 at 8:00am ET to present results from its Phase 2 clinical trial of silevertinib and to provide a program update.
Investors can access the webcast under “Events and Presentations” in the Investors section at www.blackdiamondtherapeutics.com. A replay will be available after the event.