Welcome to our dedicated page for Macrogenics news (Ticker: MGNX), a resource for investors and traders seeking the latest updates and insights on Macrogenics stock.
MacroGenics, Inc. develops antibody-based therapeutics for cancer, with pipeline work built around monoclonal antibodies, DART and TRIDENT multi-specific molecules, and antibody-drug conjugates. Company news commonly covers clinical and regulatory updates for lorigerlimab, MGC026 and MGC028, including FDA communications tied to study conduct and safety monitoring.
Updates also address financial results, capital-resource commentary, strategic collaborations and licensing economics, including royalty interests tied to ZYNYZ (retifanlimab-dlwr), a PD-1 inhibitor originally developed by MacroGenics and licensed to Incyte.
MacroGenics, Inc. (NASDAQ: MGNX) announced positive results from a Phase 2 study published in Lancet Oncology, showcasing the efficacy of margetuximab combined with pembrolizumab as a chemotherapy-free treatment for HER2-positive gastroesophageal adenocarcinoma (GEA). The study found an objective response rate (ORR) of 18% and a disease control rate (DCR) of 53% among treated patients. Notably, the ORR was 44% in patients with high HER2 and PD-L1 expression. The ongoing Phase 2/3 MAHOGANY trial aims to further evaluate this regimen as a first-line therapy.
MacroGenics, Inc. (NASDAQ: MGNX) has announced the hiring of Stephen Eck, M.D., Ph.D., as Senior Vice President, Clinical Development & Chief Medical Officer, effective July 1, 2020. Dr. Eck brings over 20 years of experience in oncology therapeutics from previous roles at Immatics US and Astellas Pharma, among others. This addition is expected to enhance MacroGenics' presence in clinical development. Ezio Bonvini, M.D., will resume his role as Chief Scientific Officer after overseeing clinical development on an interim basis.
MacroGenics, Inc. (NASDAQ: MGNX) announced research in Science Translational Medicine revealing a gene expression signature in the tumor microenvironment of acute myeloid leukemia (AML) patients. This signature is linked to chemotherapy resistance and potential response to flotetuzumab, a bispecific DART molecule for patients with primary induction failure or early relapsed AML. The study emphasizes flotetuzumab's promise in addressing unmet medical needs in difficult AML patient populations, as highlighted by Chief Scientific Officer Ezio Bonvini.
MacroGenics (NASDAQ: MGNX) announced plans for a pivotal clinical study of flotetuzumab, a bispecific DART molecule targeting CD123 and CD3, aimed at treating acute myeloid leukemia (AML) patients who are refractory to induction therapy. Following recent discussions with the FDA, the single-arm study will enroll up to 200 patients with primary induction failure or early relapse AML. Primary endpoints include complete remission rates, with secondary endpoints assessing response durability. Previous data showed a 27% CR/CRh rate in a smaller trial, indicating potential therapeutic value for a serious unmet medical need.
MacroGenics, Inc. (NASDAQ: MGNX) announced a conference call on May 29, 2020, to discuss preliminary clinical results from ongoing Phase 1 studies of MGD013 and MGC018 at the ASCO20 Virtual Scientific Program. MGD013 is a bispecific DART molecule targeting PD-1 and LAG-3, while MGC018 is an antibody-drug conjugate for advanced solid tumors expressing B7-H3. Both candidates are crucial for MacroGenics’ oncology portfolio and are in various phases of clinical trials, showing potential for significant growth and strategic partnerships.
MacroGenics, Inc. (NASDAQ: MGNX) reported preliminary results from its Phase 1 trials for MGD013, a bispecific DART molecule targeting PD-1 and LAG-3, and MGC018, an ADC targeting B7-H3. Data indicates approximately 40% response in late-stage HER-2-positive tumors with MGD013 combined with margetuximab. In MGC018's trial, 5 of 7 patients with prostate cancer showed PSA reductions of 50% or more. The results will be presented at the ASCO20 Virtual Scientific Program, scheduled for May 29-31, 2020.
MacroGenics, Inc. (NASDAQ: MGNX) reported its Q1 2020 financial results, revealing total revenue of $13.7 million, up from $9.7 million in Q1 2019, primarily due to increased collaborative agreements. R&D expenses rose to $48.9 million, leading to a net loss of $44.7 million, slightly lower than the previous year's loss of $45.0 million. The company maintains cash reserves of $170.8 million, projected to sustain operations into 2022. Key upcoming clinical data presentations and a PDUFA date for margetuximab in December 2020 were highlighted, despite potential COVID-19 related delays in clinical trials.
Summary not available.
Summary not available.
Summary not available.