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Black Diamond Therapeutics, Inc. (Nasdaq: BDTX) provided an update on their clinical programs, including BDTX-1535 for EGFR mutant NSCLC and GBM, and BDTX-4933 for KRAS mutant NSCLC. The FDA feedback allows the initiation of Phase 2 cohort for BDTX-1535 in first-line treatment of non-classical EGFR mutant NSCLC. Fast Track Designation was granted for BDTX-1535 as a second-line treatment for EGFR mutant/C797S NSCLC. Phase 2 results for 2L/3L patients with EGFR mutant NSCLC are expected in Q3 2024. Phase 1 clinical trial results and 'window of opportunity' data in patients with EGFR mutant GBM are anticipated to be presented in Q2 2024. Cash, cash equivalents, and investments are expected to be sufficient to fund milestone achievements and operations into Q2 2025.
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End-of-Day
-0.73%
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Black Diamond Therapeutics, Inc. (Nasdaq: BDTX) announced promising clinical activity in heavily pretreated patients with recurrent glioblastoma (GBM) expressing epidermal growth factor receptor (EGFR) alterations. BDTX-1535, a fourth-generation, brain-penetrant, covalent EGFR inhibitor, demonstrated encouraging results in Phase 1 clinical trial, with 22 patients showing efficacy, including 3 patients on therapy longer than 10 months, 1 patient longer than 6 months, and 5 patients longer than 4 months. Additionally, 1 patient achieved a confirmed partial response and 8 patients experienced stable disease. Safety data revealed no new signals, with primarily Grade 1 and 2 diarrhea and rash. Enrollment is ongoing in a 'window of opportunity' clinical trial to assess PK and PD in brain tissue in second-line patients with high-grade glioma.
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-9.03%
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Black Diamond Therapeutics, Inc. (Nasdaq: BDTX) announced that its President and CEO, Mark A. Velleca, M.D., Ph.D., will participate in fireside chats at two investor conferences in November 2023. Webcasts will be available on the company's website, with replays accessible for 90 days.
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-4.71%
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Black Diamond Therapeutics reports positive Phase 1 data for BDTX-1535 in NSCLC patients and provides corporate update
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0.53%
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Black Diamond Therapeutics to present at AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics, showcasing Phase 1 data for BDTX-1535 in NSCLC and GBM, and preclinical data for BDTX-4933.
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-5.56%
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Mark Velleca appointed CEO of Black Diamond Therapeutics, replacing David Epstein. Velleca aims to advance the company's clinical stage programs and create value for stakeholders.
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-1.41%
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Black Diamond Therapeutics announces dosing of first patients in mutation matched expansion cohorts of NSCLC clinical study for BDTX-1535
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-0.29%
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Black Diamond Therapeutics, Inc. (Nasdaq: BDTX) to participate in three upcoming investor conferences.
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-1.12%
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Black Diamond Therapeutics reports positive initial clinical data for BDTX-1535 in NSCLC patients with acquired resistance and intrinsic driver EGFR mutations. Expansion cohorts initiated. Underwritten public offering raises $75.0 million. Cash position of $89.5 million. Milestones include FDA meeting and clinical update in Q4 2023.
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-2.35%
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Black Diamond Therapeutics, Inc.
Nasdaq:BDTX
BDTX Rankings
BDTX Stock Data
266.15M
35.92M
2.61%
93.57%
3.95%
Research and Development in Biotechnology
Professional, Scientific, and Technical Services
United States of America
CAMBRIDGE
About BDTX
black diamond therapeutics, inc., a precision oncology medicine company, discovers and develops small molecule, tumor-agnostic therapies. its lead product candidate is bdtx-189, an inhibitor of non-canonical and oncogenic mutations of erbb kinases epidermal growth factor receptor (egfr) and tyrosine-protein kinase. the company is also developing allosteric-egfr mutation inhibitors; and various early stage pipeline programs targeting allosteric mutations in kinases related to cancer and/or rare genetic diseases. the company was formerly known as aset therapeutics, inc. and changed its name to black diamond therapeutics, inc. in january 2018. black diamond therapeutics, inc. was founded in 2014 and is headquartered in cambridge, massachusetts.