October 16, 2020 - An amended complaint was filed.

September 13, 2020 - An investor in shares of MacroGenics, Inc. (NASDAQ: MGNX) filed a lawsuit in the U.S. District Court for the District of Maryland over alleged violations of Federal Securities Laws by MacroGenics, Inc. in connection with certain allegedly false and misleading statements made between February 6, 2019 and June 3, 2019.

Rockvillem MD based MacroGenics, Inc., a biopharmaceutical company, discovers and develops antibody-based therapeutics 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.

On May 13, 2019, the American Society of Clinical Oncologists (“ASCO”) posted the SOPHIA study abstract on the Internet. The abstract disclosed that the October 2018 PFS analysis resulted in a 0.9 month improvement in PFS.

Then on June 4, 2019, during the ASCO annual meeting, MacroGenics, Inc disclosed additional data for the SOPHIA trial. In its presentation, MacroGenics, Inc revealed that it had conducted the PFS and OS analyses in October 2018, and the OS analyses for the SOPHIA trial demonstrated Kaplan-Meier curves crossing at several spots with late separation. Shares of MacroGenics, Inc. (NASDAQ: MGNX) declined from $32.32 per share in Febuary 2019 to as low as $12.79 per share on September 13, 2019.

According to the complaint the plaintiff alleges on behalf of purchasers of MacroGenics, Inc. (NASDAQ: MGNX) common shares between February 6, 2019 and June 3, 2019, that the defendants violated Federal Securities Laws.

More specifically, the plaintiff claims that between February 6, 2019 and June 3, 2019, the defendants concealed material information and/or failed to disclose that 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, that the October 2018 PFS analysis showed a 0.9 month improvement in PFS, and that 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.