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, Inc. (NASDAQ: BDTX) is a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in cancer. The company’s news flow centers on the development of its lead program, silevertinib (also known as BDTX-1535), a brain-penetrant fourth-generation EGFR MasterKey inhibitor being studied in EGFR-mutant non-small cell lung cancer (NSCLC) and glioblastoma (GBM).
On this page, readers can follow company announcements related to clinical trial progress, including Phase 2 data updates in frontline NSCLC patients with non-classical EGFR mutations and investigator-sponsored studies in EGFR-altered GBM. Black Diamond’s releases describe objective response rates, CNS activity, duration of treatment or response, and plans for randomized Phase 2 trials in newly diagnosed GBM patients.
News items also cover corporate and financial updates, such as quarterly and annual financial results, cash runway commentary, and strategic priorities around advancing silevertinib. In addition, Black Diamond reports on business development activities, including a global licensing agreement with Servier for BDTX-4933, a Phase 1 therapy designed to target RAF/RAS-mutant solid tumors.
Investors and observers can use this news feed to track webcast and conference presentations, regulatory and development plans in NSCLC and GBM, and partnership discussions around pivotal development. Regular updates provide insight into how Black Diamond Therapeutics is progressing its MasterKey therapies across genetically defined tumor types and CNS-involved disease.
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.
Black Diamond Therapeutics (NASDAQ: BDTX) announced participation in four investor conferences in November–December 2025 with presentations by President and CEO Mark Velleca, M.D., Ph.D.
Scheduled events: Stifel Healthcare Conference fireside chat on Nov 11, 2025 at 9:20 AM ET; Guggenheim Healthcare Innovation fireside chat on Nov 12, 2025 at 9:00 AM ET; Piper Sandler Healthcare Conference fireside chat on Dec 4, 2025 at 1:00 PM ET; and Raymond James CEO Strategy Series on Dec 5, 2025 at 10:00 AM ET. Investors should contact their Raymond James representative to attend.
Webcasts will begin at each presentation start time and will be available on the investor relations section of the company website, with replays archived for 90 days.
Black Diamond Therapeutics (Nasdaq: BDTX) reported Q3 2025 results and a corporate update on Nov 6, 2025. The company ended Q3 with $135.5 million in cash, cash equivalents and investments, which it expects will fund operations into Q4 2027. Black Diamond will disclose ORR and preliminary duration of treatment data later this quarter from all n=43 patients in its silevertinib Phase 2 frontline EGFRm NSCLC trial; PFS data is expected in H1 2026. Q3 operating metrics: net loss $8.5M, R&D $7.4M, G&A $3.5M, and net cash used in operations $7.9M for the quarter.
Black Diamond Therapeutics (NASDAQ:BDTX) has reported its Q2 2025 financial results and provided significant updates on its clinical programs. The company has completed enrollment (n=43) in the Phase 2 trial of silevertinib for frontline non-classical EGFRm NSCLC patients, with ORR and preliminary DOR data expected in Q4 2025.
The company ended Q2 2025 with $142.8 million in cash and investments, up from $98.6 million at the end of 2024, providing runway into Q4 2027. Net loss improved to $10.6 million compared to $19.9 million in Q2 2024, with reduced R&D expenses of $9.3 million and G&A expenses of $4.1 million.
Black Diamond is actively exploring partnership opportunities for silevertinib's pivotal development in NSCLC and GBM, and plans to meet with the FDA in 1H 2026 regarding the 1L NSCLC development path when PFS data becomes available.
Black Diamond Therapeutics (BDTX), a clinical-stage oncology company focused on developing MasterKey therapies for cancer patients, has announced its participation in the upcoming Jefferies Global Healthcare Conference. CEO Mark Velleca will engage in a fireside chat on June 4, 2025 from 4:20-4:50pm ET in New York. The company will also conduct one-on-one investor meetings during the event. A webcast of the presentation will be accessible through Black Diamond's website and remain archived for 90 days post-event.
Black Diamond Therapeutics (Nasdaq: BDTX), a clinical-stage oncology company specializing in MasterKey therapies for cancer treatment, has announced its upcoming participation in two major investor conferences.
The company's President and CEO, Mark Velleca, M.D., Ph.D., will present at the following events:
- 24th Annual Needham Virtual Healthcare Conference - April 7, 2025, at 3:00 PM ET
- Stifel 2025 Virtual Targeted Oncology Forum - April 8, 2025, at 1:00 PM ET
Both presentations will be accessible via webcast on the investor relations section of Black Diamond Therapeutics' website, with replays available for 90 days.
Servier and Black Diamond Therapeutics (BDTX) have entered into a global licensing agreement for BDTX-4933, a Phase 1 targeted oncology therapy. The deal includes a $70 million upfront payment to Black Diamond, with potential additional payments of up to $710 million in development and commercial milestones, plus tiered royalties.
BDTX-4933 is designed as a potential best-in-class treatment targeting both RAS mutations and RAF alterations in solid tumors, including non-small cell lung cancer (NSCLC). The drug is currently in Phase 1 development, evaluating safety, tolerability, and antitumor activity in patients with recurrent advanced/metastatic cancers harboring BRAF, CRAF, or NRAS mutations.
Under the agreement, Servier will lead global development activities and commercialization of BDTX-4933 across multiple indications.
Black Diamond Therapeutics (BDTX) has reported its Q4 and full year 2024 financial results. The company ended 2024 with $98.6 million in cash and equivalents, projected to fund operations into Q4 2026. Net loss for Q4 2024 was $16.0 million, improved from $19.4 million in Q4 2023.
Key developments include anticipated Phase 2 clinical data for BDTX-1535 in Q2 2025 for first-line non-classical EGFRm NSCLC patients. The company plans to expand its 'window of opportunity' trial into newly diagnosed glioblastoma patients with EGFR aberrations in Q1 2025.
Financial metrics show R&D expenses decreased to $51.3 million in 2024 from $59.4 million in 2023, while G&A expenses slightly increased to $27.5 million from $27.1 million. Full-year net loss improved to $69.7 million compared to $82.4 million in 2023.
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