According to the Complaint, MacroGenics, Inc. is a clinical stage biopharmaceutical company focused on the development of antibody-based therapeutics designed to control the human immune response for the treatment of cancer in the United States. Its pipeline of immuno-oncology product candidates includes margetuximab, an investigational monoclonal antibody that targets the HER2 oncoprotein. HER2 is expressed by tumor cells in breast, gastroesophageal and other solid tumors. The SOPHIA study is a randomized, open-label Phase III clinical trial evaluating margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer.

The Complaint alleges that throughout the Class Period, Defendants violated the federal securities laws by disseminating false and misleading statements to the investing public and/or failing to disclose adverse facts pertaining to the Company’s Phase III SOPHIA trial. Specifically, the Complaint alleges Defendants concealed material information and/or failed to disclose that: (a) the Company had conducted the progression-free survival (“PFS”) and first interim overall survival (“OS”) analyses for the SOPHIA trial by no later than October 10, 2018; (b) the October 2018 PFS analysis showed a 0.9 month improvement in PFS; and (c) the October 2018 OS interim analysis did not produce a statistically significant result and the interim OS Kaplan-Meier curves (a non-parametric statistic used to estimate the survival function from lifetime data) crossed in several spots (thereby violating the constant hazard assumption) and separated late.

On August 17, 2020, the Court issued an Order appointing Lead Plaintiff and Counsel. Lead Plaintiff filed an amended Complaint on October 16. Defendants filed a Motion to Dismiss on November 30. On September 29, 2021, the Court issued an Order granting Defendants' Motion to Dismiss and directed the clerk to close the case. Lead Plaintiff filed a notice appealing the Court's Dismissal Order on October 28.

On March 2, 2023, the Court of Appeals upheld the District Court's Dismissal Order.