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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 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.
Black Diamond Therapeutics (BDTX) reported Q3 2024 financial results and corporate updates. The company announced encouraging Phase 2 data for BDTX-1535 in NSCLC patients, showing a 42% overall response rate in 19 patients with osimertinib resistance mutations. Cash position stood at $112.7 million as of September 30, 2024, expected to fund operations into Q2 2026. Q3 net loss improved to $15.6 million from $23.0 million year-over-year. The company implemented a corporate restructuring, deprioritizing BDTX-4933 to focus on BDTX-1535 development. Clinical updates and regulatory feedback are expected in Q1 2025.
Black Diamond Therapeutics (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies for cancer treatments, announced its upcoming participation in two major investor conferences. President and CEO Mark Velleca will present at the Stifel Healthcare Conference on November 19, 2024, at 4:10pm ET, and the Piper Sandler 36th Annual Healthcare Conference on December 4, 2024, at 3:00pm ET. Webcasts will be available on the company's website and archived for 90 days.
Black Diamond Therapeutics (Nasdaq: BDTX) announced a corporate restructuring to focus resources on advancing its lead program BDTX-1535 into pivotal development for EGFRm NSCLC. The company aims to extend its cash runway into Q2 2026. Key points include:
- Anticipates sharing initial Phase 2 data for BDTX-1535 in the frontline setting for EGFRm NSCLC in Q1 2025
- Plans to present updated Phase 2 results for BDTX-1535 in recurrent EGFRm NSCLC in Q1 2025
- Deprioritizing BDTX-4933 program and seeking potential partners
- Implementing a reduction in force while retaining core expertise
- Chief Business Officer, CFO, and Chief People Officer departing; Erika Jones appointed as Principal Financial Officer
The restructuring aims to optimize operations and focus investment on BDTX-1535, which has shown robust Phase 2 clinical activity in recurrent NSCLC patients with EGFR mutations.