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 (BDTX)/b) will participate in a fireside chat at the H.C. Wainwright 28th Annual Global Investment Conference on September 15, 2026, in New York, NY.The session featuring Chief Scientific Officer Elizabeth Buck, Ph.D., is scheduled for 10:00–10:30 a.m. ET. A live webcast and 90-day replay will be available under “Events and Presentations” in the Investors section of the company’s website. The company will also host one-on-one investor meetings that day.
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.