Macrogenics Inc Stock Price, News & Analysis

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.

MacroGenics has partnered with EVERSANA to commercialize its investigational drug margetuximab for HER2-positive breast cancer in the U.S., pending FDA approval. The agreement entails shared commercialization expenses, with EVERSANA receiving revenue share payments capped at 125% of its service fees over five years. The BLA for margetuximab is under FDA review, with a decision expected by December 18, 2020. MacroGenics maintains development control, focusing on further clinical evaluations of margetuximab in various cancers.

MacroGenics, Inc. (NASDAQ: MGNX) announced the achievement of $25 million in milestones related to its collaboration with Incyte for retifanlimab, an anti-PD-1 antibody. These milestones were triggered by clinical and regulatory advancements, including the launch of the POD1UM-303 Phase 3 trial for metastatic squamous cell anal carcinoma. MacroGenics can earn up to $365 million in additional development milestones and $330 million in commercial milestones from Incyte. If approved, it could also receive royalties between 15% and 24% on global sales of retifanlimab.

MacroGenics, a clinical-stage biopharmaceutical company focused on cancer therapies, has announced its participation in several investor conferences in November and December 2020. Key events include the Credit Suisse Annual Virtual Healthcare Conference on November 10, the Stifel 2020 Virtual Healthcare Conference on November 17, and the Evercore ISI HealthCONx Virtual Conference on December 2. Each event will involve one-on-one meetings and presentations by management. Webcasts of the conferences will be available for 30 days on MacroGenics' Investor Relations webpage.

MacroGenics, Inc. (NASDAQ: MGNX) reported its financial results for Q3 2020, revealing total revenue of $18.2 million, nearly identical to $18.7 million in Q3 2019. R&D expenses slightly decreased to $44.7 million from $44.9 million. The net loss was $36.0 million, down from $44.6 million year-over-year. The company is progressing on pivotal studies for margetuximab, flotetuzumab, and retifanlimab, with the PDUFA action date for margetuximab set for December 18, 2020. The company held a conference call today to discuss these results.