Clovis Oncology Inc (NASDAQ:CLVS) announced that it has submitted its New Drug Application (NDA) regulatory filing to the U.S. Food and Drug Administration (FDA) for rociletinib 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 as detected by an FDA approved test. Rociletinib is the Company’s novel, oral targeted covalent (irreversible) mutant-selective inhibitor of EGFR in development for the treatment of NSCLC in patients with initial activating EGFR mutations, as well as the dominant resistance mutation T790M. Rociletinib was granted Breakthrough Therapy designation by the U.S. FDA in May 2014.
In addition, Clovis has also submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) through the centralized procedure for rociletinib for the treatment of adult patients with mutant EGFR NSCLC who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation.
There is a validation period before both applications are formally accepted, after which the review commences.
“The submissions of our first NDA and MAA for rociletinib represent a major step forward for our company,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “These two submissions – completed on the same day, no less — were made possible through the tremendous commitment and hard work of Clovis employees and our clinical collaborators at leading U.S. and international academic institutions over the last many months, and I am grateful for their tireless efforts. We are actively preparing for what we hope to be our first U.S. commercial launch, and the opportunity to address the needs of patients with T790M-positive EGFR-mutant non-small cell lung cancer. We are also actively building our commercial organization in Europe to prepare for a potential launch next year.”
QIAGEN, Clovis’ companion diagnostic partner, intends to file a supplemental PMA application of its approved therascreen EGFRtest with the FDA to allow for regulatory approval of the companion diagnostic concurrent with rociletinib approval. Analytical performance of the therascreen EGFR test has been established for 21 EGFR mutations, including the most prevalent resistance mutation, T790M. The test supports efficient laboratory workflow with real-time PCR technology on the FDA approved Rotor-Gene Q MDx, which is part of QIAGEN’s QIAsymphony family of laboratory solutions. (Original Source)
Shares of Clovis Oncology Inc closed last Friday at $84.43 . CLVS has a 1-year high of $102.28 and a 1-year low of $35.33. The stock’s 50-day moving average is $85.77 and its 200-day moving average is $80.55.
On the ratings front, Clovis Oncology Inc (NASDAQ: CLVS) has been the subject of a number of recent research reports. In a report issued on July 20, Goldman Sachs analyst Terence Flynn upgraded CLVS to Buy. Separately, on July 2, Mizuho’s Peter Lawson maintained a Buy rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Terence Flynn and Peter Lawson have a total average return of 29.2% and 13.6% respectively. Flynn has a success rate of 79.4% and is ranked #180 out of 3722 analysts, while Lawson has a success rate of 62.3% and is ranked #394.
The street is mostly Bullish on CLVS stock. Out of 5 analysts who cover the stock, 4 suggest a Buy rating and one recommends to Hold the stock. The 12-month average price target assigned to the stock is $106.67, which implies an upside of 26.3% 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.