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, Inc. (NASDAQ: MGNX) has announced the upcoming commercial launch of its first FDA-approved drug, MARGENZA, expected in March 2021. The approval was granted for treating HER2-positive breast cancer in patients with prior anti-HER2 treatments. The company reported a revenue increase to $104.9 million for 2020, up from $64.2 million in 2019, alongside a reduced net loss of $129.7 million compared to $151.8 million the previous year. Key clinical trials, including those for flotetuzumab and margetuximab, are set to advance in 2021, with multiple updates anticipated throughout the year.
MacroGenics, Inc. (Nasdaq: MGNX) announced it will release its financial results for Q4 and full year 2020 on February 25, 2021, after market close. A conference call to discuss the results and corporate progress will occur the same day at 4:30 PM ET. Interested parties can join by calling (877) 303-6253 domestically or (973) 409-9610 internationally, using Conference ID 6094343. A listen-only webcast will be available on the company’s Investor Relations page and accessible for 30 days post-call.
MacroGenics, Inc. (Nasdaq: MGNX) announced the appointment of Federica O’Brien to its Board of Directors. With 25 years of financial and operational experience, O’Brien will also join the Audit Committee, bringing insights from her roles at various biopharmaceutical and medical device companies. CEO Scott Koenig expressed confidence in her ability to guide the company as it prepares to launch its first product and enhance its cancer treatment options.
MacroGenics (Nasdaq: MGNX) announced a $10 million milestone related to the development of retifanlimab under its global collaboration with Incyte. The FDA has accepted Incyte's BLA for retifanlimab, targeting a PDUFA action date of July 25, 2021, for treating advanced squamous carcinoma of the anal canal. Incyte is conducting Phase 3 trials of retifanlimab for non-small cell lung cancer and other cancers. MacroGenics has received $65 million in milestones, with potential total milestones of $355 million and commercial royalties ranging from 15% to 24% on net sales.
MacroGenics, a biopharmaceutical company focused on monoclonal antibody therapies for cancer, will participate in two investor conferences in February 2021. The first is the Guggenheim Healthcare Talks 2021 Oncology Day on February 11 at 11:30 AM ET, followed by the SVB Leerink 10th Annual Global Healthcare Conference on February 24 at 12:00 PM ET. Both events will be held virtually, and presentations can be accessed under the 'Events & Presentations' section on the MacroGenics website. Archived replays will be available for 30 days post-conference.
MacroGenics, Inc. (Nasdaq: MGNX) announced successful results from the Phase 3 SOPHIA trial for MARGENZA (margetuximab-cmkb), showing a 24% reduction in disease progression compared to Herceptin (trastuzumab) in metastatic HER2-positive breast cancer patients. This therapy is approved in the U.S. for patients with advanced disease who have undergone multiple prior treatments. The median progression-free survival (PFS) was 5.8 months for MARGENZA versus 4.9 months for Herceptin. The company plans to commercialize MARGENZA in March 2021.
MacroGenics, Inc. (Nasdaq: MGNX) announced its participation in two investor conferences in January 2021. The first event is the H.C. Wainwright & Co. BioConnect 2021 Conference, featuring an on-demand corporate overview and a panel discussion on Precision Medicine with CEO Scott Koenig on January 13 at noon ET. The second event is the 39th Annual J.P. Morgan Healthcare Conference on January 14 at 10:00 AM ET, where MacroGenics will provide a corporate overview and engage in one-on-one meetings. Webcasts of the presentations will be available on the company’s website.
MacroGenics, Inc. (NASDAQ: MGNX) announced positive preliminary results for its investigational drug MGD019, a PD-1 × CTLA-4 bispecific DART molecule, in a dose escalation clinical study. The findings were published in Cell Reports Medicine. MGD019 demonstrated an acceptable safety profile with no dose-limiting toxicities observed among 33 cancer patients, including some with advanced solid tumors previously unresponsive to checkpoint inhibitors. The study indicates potential for enhanced selectivity in immune checkpoint blockade, warranting further clinical investigation.
MacroGenics, Inc. (NASDAQ: MGNX) announced a collaboration with Janssen Biotech, Inc. to develop a preclinical bispecific molecule using its DART® platform. MacroGenics will receive a $20 million upfront payment and could earn up to $312 million in milestone payments and tiered royalties on product sales. This collaboration aims to leverage the combined expertise of both companies in creating innovative therapeutics outside oncology, targeting unmet patient needs. The agreement signifies a promising step in MacroGenics' strategic partnerships and growth potential.
The U.S. Food and Drug Administration (FDA) has approved MARGENZA (margetuximab-cmkb), a new HER2-targeted therapy for adult patients with metastatic HER2-positive breast cancer, who have undergone at least two prior anti-HER2 treatments. This approval is based on the Phase 3 SOPHIA trial, which demonstrated a 24% reduction in the risk of disease progression compared to trastuzumab plus chemotherapy. The product launch is anticipated in March 2021, signaling significant advancements in treatment options for patients with limited alternatives.