- Company Name
- Tesaro Incorporated
- Stock Symbol
- Class Period
- March 14, 2016 to January 12, 2018
- Motion Deadline
- March 18, 2018
- District of Massachusetts
The complaint charges Tesaro and certain of its officers with violations of the Securities Exchange Act of 1934. Tesaro is an oncology-focused biopharmaceutical company that identifies, acquires, develops and commercializes cancer therapeutics and oncology supportive care products in the United States. Tesaro’s product portfolio includes Varubi (rolapitant), a neurokinin-1 receptor antagonist for the prevention of chemotherapy-induced nausea and vomiting.
In 2015, the U.S. Food and Drug Administration (“FDA”) approved an oral version of Varubi. On March 14, 2016, Tesaro announced that it had submitted a New Drug Application to the FDA for an intravenous formulation of Varubi, and on October 25, 2017, Tesaro announced that the FDA had approval the intravenous version of Varubi.
The complaint alleges that throughout the Class Period, defendants made materially false and misleading statements and/or failed to disclose adverse information regarding Varubi, including that substantial undisclosed health risks, such as anaphylaxis and anaphylactic shock, had been reported in the post-marketing setting for Tesaro’s intravenous formulation of Varubi. As a result of this information being withheld from the market, Tesaro securities traded at artificially inflated prices during the Class Period, with its stock price reaching a high of $190.36 per share.
Then on January 12, 2018, after the market closed, Tesaro announced that, in collaboration with the FDA, it had updated the ”CONTRAINDICATIONS, WARNINGS and PRECAUTIONS, and ADVERSE REACTIONS sections” of its U.S. labeling for the intravenous formulation of Varubi after receiving reports of “[a]naphylaxis, anaphylactic shock and other serious hypersensitivity reactions . . . in the postmarketing setting, some requiring hospitalization.” The Company further stated that it had “issued a Dear Healthcare Professional (DHCP) letter” to ensure that “patients and healthcare providers [were] aware of the label update.” On this news, the price of Tesaro stock fell $4.07 per share, or nearly 6%, to close at $65.52 per share on January 16, 2018.