MacroGenics, Inc. - MGNX STOCK NEWS

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.

MacroGenics (NASDAQ: MGNX) announced promising results from a study of tebotelimab for relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The preliminary objective response rate (ORR) was 53.8% in 13 evaluable patients, including responses in both CAR T cell-naïve and experienced groups. A duration of response of up to 168 days was observed. The drug was generally well-tolerated, with a low incidence of serious adverse events. MacroGenics plans to continue enrollment in ongoing studies and looks forward to future data presentations.

MacroGenics, Inc. (NASDAQ: MGNX) announced updated results from a study of flotetuzumab in patients with primary induction failure (PIF) and early relapsed (ER6) acute myeloid leukemia (AML). The treatment achieved a 31.8% CR/CRh/CRi rate and a median response duration of 8.13 months. Among the 44 patients treated, many had adverse risk factors, yet 57.1% of responders received allogeneic stem cell transplants. The most common adverse event was mild cytokine release syndrome. This promising data was presented at the American Society of Hematology's Annual Meeting.