Shares of Athenex Inc. ATNX,
fell 54.6% in Monday’s very active trading on Monday afternoon, enough to be the biggest decline in major U.S. trade lists, after the Food and Drug Administration said the New Drug Application (NDA ) of the biopharmaceutical company for the metastatic treatment of breast cancer, oral paclitaxel plus encequidar, is not ready for approval in its current form. The volume of transactions increased to 40.1 million shares, compared to the all-day average of about 1.1 million shares. The company said earlier that the FDA had issued a full response letter (CRL), expressing concern about the safety risk to patients, and recommended a new clinical trial. Separately, the company reported a net loss in the fourth quarter that extended to $ 49.5 million, or 53 cents a share, from $ 21.7 million, or 28 cents a share, during the period a year ago, higher than the consensus FactSet for a share loss of 44 cents. Revenue fell 36.5% to $ 21.8 million, surpassing the $ 20.7 million FactSet consensus. The stock has lost 55.1% in the last 12 months, while iShares Nasdaq Biotechnology ETF IBB,
rose 40.2% and the S&P 500 SPX,
advanced by 32.4%.