MacroGenics Announces Continuation of SOPHIA Study of Margetuximab Based on Completion of Interim Futility Analysis

MacroGenics (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced completion of a pre-planned interim futility analysis of the Phase 3 SOPHIA trial.
As quoted in the press release:

MacroGenics also announced today that the U.S. FDA has granted Fast Track designation for the investigation of margetuximab for treatment of patients with metastatic or locally advanced HER2 positive breast cancer who have previously been treated with anti-HER2-targeted therapy.  Fast Track designation is designed to facilitate the development and expedite the review of new therapies for serious conditions and unmet medical needs. With Fast Track designation, early and frequent communications between the FDA and the sponsor are encouraged to help enable rapid development of the candidate molecule.

Click here to read the full press release.