Shares of Athenex Inc. ATNX,
54.6% plummeted in highly active afternoon trading on Monday, enough to be the biggest downturn on major U.S. stock exchanges, after the Food and Drug Administration said the biopharmaceutical company’s New Drug Application (NDA) for the treatment of metastatic breast cancer , oral paclitaxel plus encequidar, said. is not ready for approval in its current form. Trading volume increased to 40.1 million shares, compared to the daily average of approximately 1.1 million shares. The company previously said the FDA had issued a full response letter (CRL) raising concerns about a safety risk to patients, and recommended conducting a new clinical trial. Separately, the company reported a fourth-quarter net loss that amounted to $ 49.5 million, or 53 cents a share, from $ 21.7 million, or 28 cents a share, in the same period a year ago, broader than the FactSet consensus for one share per share. loss of 44 cents. Sales fell 36.5% to $ 21.8 million, above the FactSet consensus of $ 20.7 million. The stock has lost 55.1% in the past 12 months, while the iShares Nasdaq Biotechnology ETF IBB,
Up 40.2% and the S&P 500 SPX,
is up 32.4%.