Clovis Oncology Inc (NASDAQ:CLVS) announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for Clovis’ New Drug Application (NDA) for rociletinib by the standard extension period of three months with the new goal date of June 28, 2016. Rociletinib is an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation.
Clovis submitted a Major Amendment on November 16, 2015 in response to the FDA’s request for additional clinical data for both the 500mg and 625mg BID dose patient groups for rociletinib. As expected, the FDA extended the PDUFA goal date to allow additional time for review of the new information requested by the Agency. (Original Source)
Shares of Clovis Oncology closed today at $33.42, up $2.27 or 7.29%. CLVS has a 1-year high of $116.75 and a 1-year low of $24.50. The stock’s 50-day moving average is $60.80 and its 200-day moving average is $81.00.
On the ratings front, Clovis Oncology has been the subject of a number of recent research reports. In a report issued on November 18, Goldman Sachs analyst Terence Flynn downgraded CLVS to Hold, with a price target of $23, which implies a downside of 26.3% from current levels. Separately, on November 17, WallachBeth Capital LLC’s Bob Ai downgraded the stock to Hold and has a price target of $30.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Terence Flynn and Bob Ai have a total average return of 24.1% and -12.4% respectively. Flynn has a success rate of 78.4% and is ranked #125 out of 3616 analysts, while Ai has a success rate of 30.0% and is ranked #3143.
The street is mostly Neutral on CLVS stock. Out of 6 analysts who cover the stock, 4 suggest a Hold rating and 2 recommend to Buy the stock. The 12-month average price target assigned to the stock is $25.50, which implies a downside of 18.3% from current levels.
Clovis Oncology Inc is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the United States, Europe and additional international markets.