Clovis Oncology Inc (NASDAQ:CLVS) that the U.S. Food and Drug Administration (FDA) has scheduled the New Drug Application (NDA) for rociletinib for discussion by theOncologic Drugs Advisory Committee (ODAC) on April 12, 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.
The ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes recommendations to the FDA.
“We are actively preparing for this advisory committee meeting and look forward to the discussion about rociletinib,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “New treatments are needed for this hard-to-treat patient population, and we believe that rociletinib represents an important new option for patients with mutant EGFR T790M-positive lung cancer.” (Original Source)
Shares of Clovis Oncology are trading at $18.84, up $0.24 or 1.31%. CLVS has a 1-year high of $116.75 and a 1-year low of $17.76. The stock’s 50-day moving average is $24.95 and its 200-day moving average is $63.88.
On the ratings front, Clovis has been the subject of a number of recent research reports. In a report issued on January 25, Mizuho analyst Eric Criscuolo reiterated a Hold rating on CLVS, with a price target of $23, which represents a potential upside of 23.7% from where the stock is currently trading. Separately, on January 20, Credit Suisse’s Kennen MacKay initiated coverage with a Buy rating on the stock and has a price target of $32.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Eric Criscuolo and Kennen MacKay have a total average return of -18.4% and -17.4% respectively. Criscuolo has a success rate of 25.0% and is ranked #3226 out of 3564 analysts, while MacKay has a success rate of 7.7% and is ranked #3147.
Overall, 4 research analysts have assigned a Hold rating and 4 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $23.00 which is 23.7% above where the stock closed yesterday.
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.