Robbins LLP: Clovis Oncology, Inc. (CLVS) Misled Shareholders According to a Recently Filed Class Action
Robbins LLP announces that a class action complaint was filed in the U.S. District Court for the District of Colorado. The complaint alleges that officers and directors of Clovis Oncology, Inc. (NASDAQGS: CLVS) violated the Securities Exchange Act of 1934 between October 31, 2013 and November 15, 2015, by making materially false and misleading statements about Clovis’ business prospects. Clovis is a biopharmaceutical company that focuses on acquiring, developing, and commercializing anti-cancer agents in the U.S., Europe, and internationally.
Clovis Accused of Using Immature Data Related to Its Drug Rociletinib
According to the complaint, Clovis failed to disclose that the New Drug Application (“NDA”) that it submitted for its drug rociletinib to the Food and Drug Administration (“FDA”) contained immature data sets based on both unconfirmed response rates and confirmed response rates. Further, Clovis allegedly did not disclose that its Breakthrough Therapy designation submission contained immature data sets based primarily on unconfirmed responses. The complaint also alleges that Clovis presented interim data publicly and at medical meetings that included a data set based primarily on unconfirmed responses. Lastly, as the efficacy data matured, the number of patients with an unconfirmed response who converted to a confirmed response was lower than expected, and as a result, Clovis’ NDA was likely to be delayed or rejected by the FDA.
On November 16, 2015, Clovis issued a press release disclosing that the FDA requested additional clinical data after the efficacy of rociletinib was thrown into doubt. Specifically, the FDA requested data for use in the efficacy analysis for both the 500mg and 625mg BID dose patient groups for rociletinib. On this news, Clovis stock fell $69.19 per share, or nearly 70%, to close at $30.24 on November 16, 2015.
Clovis Shareholders Have Legal Options
Concerned shareholders who would like more information about their rights and potential remedies can contact attorney Darnell R. Donahue at (800) 350-6003, or you can complete the form below and we will contact you directly.