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 announced the appointment of Rachel Humphrey, M.D. as Chief Medical Officer, effective immediately. Dr. Humphrey succeeds Karsten Witt, M.D., who will now serve as Senior Vice President of Non-Clinical Development. With extensive experience in oncology drug development, Dr. Humphrey joins from CytomX Therapeutics and has held senior roles at major pharmaceutical companies. Her leadership is expected to enhance the development of BDTX-189, an innovative inhibitor targeting oncogenic mutations across various cancers, which currently lacks a comparable FDA-approved treatment.
Black Diamond Therapeutics (BDTX) announced significant advancements regarding its lead candidate, BDTX-189, receiving FDA Fast Track designation for treating adult patients with specific solid tumors. The Phase 1/2 clinical trial is progressing as scheduled, with completion expected by mid-2021. Financially, the company reported a strong cash position of $345.0 million as of June 30, 2020, up from $39.7 million in Q2 2019. R&D expenses rose to $10.2 million, influenced by the trial's development, while G&A expenses also increased to $4.9 million.
Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a leader in precision oncology, announced that CEO David M. Epstein will present at two upcoming investor conferences. The presentations are scheduled for August 12, 2020, at the Wedbush PacGrow Healthcare Conference and August 13, 2020, at the Canaccord Genuity Growth Conference. Live webcasts will be available on the company’s website, with replays archived for three weeks. Black Diamond focuses on developing tumor-agnostic therapies targeting undrugged mutations in genetically defined cancers.
Black Diamond Therapeutics (Nasdaq: BDTX) has appointed Fang Ni, Pharm.D., as Chief Business Officer. Ni, who has previously served as interim CBO and possesses extensive expertise in business development, is expected to lead strategic initiatives to advance the company’s clinical pipeline. He is credited with contributions to Black Diamond's corporate strategies and has a solid background in oncology from his tenure at Roche and Versant Ventures. The leadership change is aimed at capitalizing on Black Diamond's innovative MAP platform for drug discovery.
Black Diamond Therapeutics (Nasdaq: BDTX) announced FDA's Fast Track designation for BDTX-189, targeting adult patients with solid tumors harboring specific mutations. This designation aims to expedite the development of BDTX-189, an orally available small molecule inhibitor, which addresses unmet needs in cancer therapy. The drug is currently undergoing evaluation in the MasterKey-01 Phase 1/2 clinical trial, assessing its safety and effectiveness in patients with advanced solid tumors. The Fast Track status allows for closer collaboration with the FDA and a potential accelerated approval process.
Black Diamond Therapeutics, Inc. (Nasdaq: BDTX) announced that CEO David M. Epstein, Ph.D., will present a business update at the BMO 2020 Healthcare Conference on June 23, 2020, at 2:00 PM ET. The presentation will be accessible via live webcast on the company's investor relations website, with a replay available for three weeks. Black Diamond focuses on precision oncology and aims to develop small molecule, tumor-agnostic therapies targeting undrugged mutations in genetically defined cancers using its proprietary MAP technology platform.
Black Diamond Therapeutics, a precision oncology company, announced that its CEO, David M. Epstein, will present at the Jefferies Virtual Healthcare Conference on June 3, 2020, at 1:30 PM ET. The presentation will cover the company's advancements in tumor-agnostic therapies, targeting undrugged mutations in cancers. Investors can access a live webcast and replay on the company’s website for three weeks. Black Diamond's MAP platform allows for the development of tailored therapies based on genetic data.
Black Diamond Therapeutics (Nasdaq: BDTX) announced that the MasterKey-01 clinical trial design for BDTX-189, its lead product candidate, will be presented at the ASCO 2020 Virtual Scientific Program from May 29-31, 2020. This Phase 1/2 trial aims to assess the safety, tolerability, pharmacokinetics, and anti-tumor activity of BDTX-189 in patients with advanced solid tumors. It targets mutations in the ErbB family of proteins. With no FDA-approved therapies for these mutations existing, BDTX-189 could represent a significant advancement in oncology.
Black Diamond Therapeutics (Nasdaq: BDTX) reported Q1 2020 financials, highlighting $357.2 million in cash and equivalents. The initial public offering in February raised $231.3 million, bolstering their position to fund operations through 2023. The Phase 1/2 clinical trial for BDTX-189, their lead therapy, is ongoing, with completion expected in the first half of 2021. Operating expenses have increased, with R&D expenses at $7.4 million and G&A expenses at $5.5 million due to increased personnel and public company costs. The net loss for the quarter was $12.1 million, reflecting continued investment in clinical development.
Black Diamond Therapeutics (Nasdaq: BDTX) announced that its CEO, David M. Epstein, Ph.D., will present a business update at the Bank of America Global Research Health Care Conference 2020. The presentation is scheduled for May 12, 2020, at 4:20 PM ET. Black Diamond is focused on developing small molecule, tumor-agnostic therapies targeting undrugged mutations in genetically defined cancers. Their proprietary Mutation-Allostery-Pharmacology (MAP) platform enables the analysis of genetic data to create therapies for specific mutation families.
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