MacroGenics, Inc. - MGNX STOCK NEWS

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.

MacroGenics, Inc. (NASDAQ: MGNX) has published new research in Blood Advances detailing the role of TP53 abnormalities in the response to flotetuzumab, an investigational therapy for acute myeloid leukemia (AML). The study indicates that patients with TP53 mutations benefit from flotetuzumab, especially those with primary induction failure (PIF) or early relapse (ER). MacroGenics plans to enroll up to 200 patients in a pivotal study, with interim results expected at an upcoming medical conference, further supporting its development strategy in this challenging patient population.

MacroGenics (MGNX) has published a manuscript in Molecular Cancer Therapeutics, detailing the preclinical development of MGC018, an antibody-drug conjugate targeting B7-H3 for solid tumors. The ADC shows promising antitumor activity and a favorable safety profile in preclinical models of various cancers. A Phase 1 dose expansion trial for MGC018 is currently recruiting patients with metastatic castration-resistant prostate cancer, triple-negative breast cancer, and non-small cell lung cancer. The company aims to provide updates on the study next year.

MacroGenics, Inc. (NASDAQ: MGNX) announced the publication of interim results from a Phase 1/2 trial of flotetuzumab, aimed at treating acute myeloid leukemia (AML). The trial enrolled 88 patients, revealing a 16.7% complete remission rate in those with primary induction failure or early relapse. Flotetuzumab, a bispecific DART molecule, effectively targets CD123 on leukemic cells and CD3 on T cells, leading to significant T-cell mediated responses. The company plans to expand its trial to 200 patients, with interim results expected later this year, highlighting potential for a pivotal study in this high-unmet-need population.