Clovis Stock Trading Halted Ahead Of FDA Meeting

Clovis Oncology Inc

disclosed, in a statement to the media, that NASDAQ has halted the trading of its shares. The move comes ahead of the US FDA's Oncologic Drugs Advisory Committee meeting that is scheduled to discuss its NDA for rociletinib on Tuesday. According to the company, the drug is for treating the patients with mutual epidermal growth factor receptor (EGFR) non-small cell lung cancer, who were earlier given treatment with an EGFR-enabled therapy. Incidentally, it had the EGFR T790M mutation. Clovis Oncology said that Rociletinib is its novel, oral, targeted covalent (irreversible) mutant-selective inhibitor of EGFR in development for the treatment of NSCLC in patients with initial activating EGFR mutations, and the dominant resistance mutation T790M. The company indicated that data from both the pivotal, single-arm TIGER-X and TIGER-2 clinical trials provided the basis for the regulatory submissions for the treatment of advanced mutant EGFR T790M-positive lung cancer. In May 2014, FDA has already granted Rociletinib Breakthrough Therapy designation. On Monday, shares of the company ended with a loss of 4.5%.