Clovis Oncology Inc (NASDAQ:CLVS) announced that the U.S. Food and Drug Administration (FDA) has accepted Clovis’ New Drug Application (NDA) for accelerated approval of rucaparib and granted priority review status to the application with a Prescription Drug User Fee Act (PDUFA) date of February 23, 2017. In lateJune 2016, Clovis completed its NDA submission of rucaparib to the FDA for the treatment of advanced ovarian cancer in patients with deleterious BRCA-mutated tumors inclusive of both germline and somatic BRCA mutations (as detected by an FDA-approved test), and who have been treated with two or more chemotherapies. Rucaparib was granted Breakthrough Therapy Designation for the proposed indication by the FDA in April 2015.
“The acceptance of the rucaparib NDA submission represents an important milestone for rucaparib, and for Clovis,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “There is tremendous need for additional therapeutic options for patients with advanced mutant BRCA ovarian cancer and we look forward to cooperating with FDA on the rucaparib NDA review.”
“Recurrent ovarian cancer remains a very difficult disease to treat, even among women who carry, or whose tumors have a mutation in the BRCA genes. Despite the available treatment options, few effective therapies are at our disposal. Thus, the opportunity to treat women with germline or somatic BRCA mutations with rucaparib after two prior lines of platinum-based therapy, represents a meaningful step forward for our patients,” said Robert L. Coleman, MD, Professor & Deputy Chairman, Vice Chair, Clinical Research, Ann Rife Cox Chair in Gynecology, Department of Gynecologic Oncology and Reproductive Medicine atUniversity of Texas MD Anderson Cancer Center in Houston and one of the Principal Investigators in the ARIEL clinical trial program.
Foundation Medicine, Clovis’ companion diagnostic partner, has submitted a Premarket Approval (PMA) application for its FoundationFocus CDxBRCA to the FDA in June 2016. The test is designed to identify tumor BRCA mutations, including germline and somatic BRCA mutations. The timing of the submission is expected to allow for regulatory approval of the companion diagnostic in a similar timeframe. (Original Source)
Shares of Clovis Oncology jumped over 26% to $22.90, as of this writing. CLVS has a 1-year high of $116.75 and a 1-year low of $11.57. The stock’s 50-day moving average is $15.25 and its 200-day moving average is $16.08.
On the ratings front, CLVS has been the subject of a number of recent research reports. In a report issued on August 19, Suntrust Robinson Humphrey analyst Peter Lawson maintained a Buy rating on CLVS, with a price target of $25, which represents a potential upside of 36.6% from where the stock is currently trading. Separately, on August 18, Stifel Nicolaus’ Thomas Shrader maintained a Buy rating on the stock 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, Peter Lawson and Thomas Shrader have a total average return of 5.7% and -11.5% respectively. Lawson has a success rate of 52.7% and is ranked #826 out of 4122 analysts, while Shrader has a success rate of 32.0% and is ranked #3880.
The street is mostly Neutral on CLVS stock. Out of 5 analysts who cover the stock, 3 suggest a Hold rating and 2 recommend to Buy the stock. The 12-month average price target assigned to the stock is $19.50, which implies an upside of 6.6% from current levels.
Clovis Oncology, Inc. is a biopharmaceutical company which focuses on acquiring, developing and commercializing cancer treatments in the United States, Europe and other international markets. The company has three product candidates in its clinical development pipeline: Rociletinib, Rucaparib and Lucitani.