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. (NASDAQ: MGNX) is a clinical-stage biopharmaceutical company based in Rockville, Maryland. The company specializes in discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer and autoimmune diseases. With a robust pipeline of product candidates, MacroGenics focuses on creating differentiated molecules targeting novel cancer markers, as well as 'bio-betters' designed to improve upon existing therapies.
MacroGenics' flagship product, MARGENZA, is approved for the treatment of adult patients with metastatic HER2-positive breast cancer. The company's pipeline also includes several promising product candidates such as MGC018 (B7-H3), Lorigerlimab (PD-1 × CTLA-4), Tebotelimab (PD-1 × LAG-3), MGD024 (CD123 × CD3), IMGC936 (ADAM9), Enoblituzumab (anti-B7-H3), Retifanlimab (PD-1), and MGD014 (HIV × CD3).
The company employs next-generation antibody-based technology platforms, including its proprietary DART® and TRIDENT® platforms, which enable the development of bispecific antibodies. These platforms are instrumental in the creation of MacroGenics' innovative product candidates and have led to several strategic collaborations with global pharmaceutical and biotechnology companies.
MacroGenics' recent achievements include a significant partnership with Gilead Sciences, Inc., focusing on bispecific antibodies. Under this agreement, Gilead has an exclusive option to license worldwide rights to the research program upon achieving pre-defined milestones, potentially earning MacroGenics up to $1.7 billion in target nomination, option fees, and milestone payments, plus tiered double-digit royalties on net sales.
The company is actively engaged in multiple clinical trials and anticipates sharing data from its TAMARACK Phase 2 study of vobramitamab duocarmazine for metastatic castration-resistant prostate cancer by the end of May 2024. Additionally, MacroGenics plans to release its financial results for the fourth quarter of 2023 on March 7, 2024, and for the first quarter of 2024 on May 9, 2024.
For more detailed information, please visit the company's website at www.macrogenics.com.
MacroGenics (MGNX) announced promising clinical data from the Phase 1 trial of MGD019, a bispecific PD-1 × CTLA-4 DART molecule targeting advanced solid tumors. The trial showed that MGD019 was well-tolerated, with no dose-limiting toxicities reported. Of the 18 evaluable patients at doses ≥ 3.0 mg/kg, 4 objective responses were noted, including a complete response in metastatic castration-resistant prostate cancer. The company plans to expand the study in patients with microsatellite stable colorectal cancer and non-small cell lung cancer at a recommended Phase 2 dose of 6.0 mg/kg.
MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company, announced participation in two investor conferences in August 2020. The BTIG Virtual Biotechnology Conference will feature one-on-one meetings and a fire-side chat on August 10 at 12:30 p.m. ET. The Wedbush PacGrow Healthcare Conference is set for August 12 at 8:35 a.m. ET, with similar one-on-one meetings and a corporate overview. Webcasts of both events will be available on the company's website for 30 days post-conference.
MacroGenics, Inc. (NASDAQ: MGNX) announced its financial results for Q2 2020, revealing a net loss of $46.9 million, compared to $31.8 million a year prior. Revenue reached $20.3 million, driven by a $12.0 million agreement with Boehringer Ingelheim. R&D expenses rose to $57.4 million, reflecting increased clinical trial costs. As of June 30, 2020, cash and marketable securities total $232.8 million, extending the company's cash runway into 2023. The company anticipates presenting additional clinical data for its investigational products in upcoming months.
MacroGenics, Inc. (Nasdaq: MGNX) announced it will release its financial results for Q2 2020 after market hours on July 30, 2020. A conference call to discuss these results and recent corporate developments is scheduled for the same day at 4:30 p.m. ET. Interested participants can join by calling (877) 303-6253 (domestic) or (973) 409-9610 (international) using Conference ID 3236629. The call will be available for replay on the company's website for 30 days.
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.
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