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) announced that its CEO, David M. Epstein, Ph.D., will speak at two upcoming investor conferences. The first is the 2021 Wedbush PacGrow Healthcare Conference on August 11, 2021, at 10:20 AM ET, where he will participate in a Targeted Oncology panel. The second event is the Canaccord Genuity 41st Annual Growth Conference, scheduled for August 12, 2021, at 1:00 PM ET. Webcasts of the presentations will be available on the company's website, along with replays for three weeks.
Black Diamond Therapeutics announced initial results from the Phase 1 dose-escalation study of BDTX-189 targeting advanced solid tumors with specific oncogenic alterations. The drug demonstrated a favorable safety profile, with manageable toxicities and pharmacokinetics aligning with preclinical data. Preliminary anti-cancer activity was noted in heavily pre-treated patients, including confirmed partial responses. The preliminary recommended Phase 2 dose is set at 800 mg once-daily. Further clinical development is planned, with data to be presented at the upcoming ASCO Annual Meeting.
Black Diamond Therapeutics (Nasdaq: BDTX) announced a webcast presentation on May 19, 2021, to discuss pharmacokinetic, safety, and preliminary efficacy data from the Phase 1 dose-escalation portion of the MasterKey-01 trial for BDTX-189, targeting advanced solid tumors. Key data will also be presented at the ASCO Annual Meeting on June 4, 2021. BDTX-189 is designed to inhibit oncogenic mutations of EGFR and HER2, with Fast Track designation from the FDA, highlighting its potential significance for patients with limited treatment options.
Black Diamond Therapeutics reported Q1 2021 results, highlighting progress in its clinical pipeline. The Phase 1/2 trial of BDTX-189 is on track, with over 50 patients dosed, aiming for initial data presentation at ASCO. The pre-clinical data for BDTX-1535 showed promising results in glioblastoma. Financially, the company held $290.1 million in cash, expected to fund operations until 2023, but R&D expenses surged to $22.8 million, up from $7.4 million in Q1 2020. General expenses also rose to $7.9 million from $5.5 million.
Black Diamond Therapeutics announced the presentation of initial pharmacokinetic, safety, and efficacy data from Phase 1 of the MasterKey-01 trial for BDTX-189.
The data will be showcased at the 2021 ASCO Annual Meeting, scheduled for June 4-8, 2021. BDTX-189 targets advanced solid tumors with oncogenic mutations of ErbB receptors.
The trial aims to determine recommended doses while evaluating its potential benefits for patients with limited treatment options. The FDA has granted Fast Track designation for this indication.
Black Diamond Therapeutics (BDTX) announced preclinical data on its therapies BDTX-189 and BDTX-1535 at the AACR Annual Meeting. BDTX-189 demonstrates a rapid and sustained target inhibition profile, with a predicted effective human dose of 400–800 mg QD. The Phase 1 MasterKey-01 trial is ongoing. Meanwhile, BDTX-1535 shows potent inhibition of EGFR variants in glioblastoma and non-small cell lung cancer. An IND application for BDTX-1535 is anticipated in H1 2022, reinforcing BDTX’s commitment to developing therapies targeting genetically defined cancers.
Black Diamond Therapeutics (Nasdaq: BDTX) announced key progress in its clinical trials and financial results for 2020. The Phase 1/2 trial of BDTX-189 is on schedule, with over 50 patients enrolled and preliminary data expected in the first half of 2021. The company anticipates starting the Phase 2 portion later this year. Cash reserves stood at $315.1 million, expected to fund operations into 2023. However, the FDA imposed a partial clinical hold on the Phase 2 enrollment due to regulatory requirements, but this will not hinder the ongoing Phase 1 study.
Black Diamond Therapeutics, Inc. (Nasdaq: BDTX) announced the presentation of pre-clinical data on BDTX-189 and BDTX-1535 at the upcoming AACR Virtual Annual Meeting from April 10-15, 2021. Notable sessions include:
- BDTX-189: Estimating clinical pharmacokinetics and doses, April 10, 8:30 AM ET.
- BDTX-1535: Efficacy in patient-derived xenograft models, April 10, 8:30 AM ET.
BDTX-189 is an innovative inhibitor targeting a range of oncogenic proteins, aiming to improve toxicity profiles compared to current therapies.
Black Diamond Therapeutics (Nasdaq: BDTX) presented pre-clinical data on its BRAF and FGFR programs at the ESMO TAT Virtual Congress 2021. The BRAF program targets non-canonical mutations and aims to prevent paradoxical activation, indicating potential anti-tumor efficacy. The FGFR program focuses on sparing FGFR1 to reduce toxicity, showing activity against FGFR2/3 mutations. Both programs plan to file Investigational New Drug (IND) applications in 2022. These studies underscore Black Diamond's commitment to addressing unmet needs in oncology.
Black Diamond Therapeutics (Nasdaq: BDTX) announced that its CEO, David M. Epstein, Ph.D., will present company updates at several upcoming investor conferences. Notable events include: the Cowen 41st Annual Virtual Health Care Conference on March 2, 2021, the H.C. Wainwright Virtual Global Life Sciences Conference starting March 9, 2021, and the 10th Annual J.P. Morgan Napa Valley Forum on March 31, 2021. Live webcasts and replays of these presentations will be available on the company's investor relations website.