Macrogenics Inc Stock Price, News & Analysis

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.

MacroGenics, Inc. (NASDAQ: MGNX) announces the presentation of six clinical and preclinical abstracts on acute myeloid leukemia (AML) and flotetuzumab at the 62nd American Society of Hematology Annual Meeting, occurring December 5-8, 2020. Key presentations include data on flotetuzumab as salvage therapy and its potential impact on AML. The company also highlights tebotelimab data in diffuse large B-cell lymphoma. These findings suggest growing interest in flotetuzumab as a treatment option for AML, supported by its orphan drug designation from the FDA.

MacroGenics, Inc. (NASDAQ: MGNX) announced it will release its Q3 2020 financial results after market close on November 4, 2020. A conference call will follow at 4:30 p.m. ET to discuss these results and recent corporate progress. Interested parties can join the call by dialing the provided numbers and using Conference ID 5986584. A webcast of the call will also be available for those unable to attend live and will be accessible for 30 days post-event on MacroGenics' Investor Relations website.