Shares of Athenex Inc. ATNX, -54.88% plummeted 54.6% on very active afternoon trading Monday, enough to be the biggest decliner listed on major U.S. exchanges, after the Food and Drug Administration said the biopharmaceutical company’s New Drug Application (NDA) for its metastatic breast cancer treatment, oral paclitaxel plus encequidar, is not ready for approval in its present form. Trading volume spiked to 40.1 million shares, compared with the full-day average of about 1.1 million shares. The company said earlier that the FDA issued a complete response letter (CRL) expressing concerns of a safety risk to patients, and recommended a new clinical trial be conducted. Separately, the company reported a fourth-quarter net loss that widened to $49.5 million, or 53 cents a share, from $21.7 million, or 28 cents a share, in the year-ago period, wider than the FactSet consensus for a per-share loss of 44 cents. Revenue fell 36.5% to $21.8 million, topping the FactSet consensus of $20.7 million. The stock has lost 55.1% over the past 12 months, while the iShares Nasdaq Biotechnology ETF IBB, +1.73% has climbed 40.2% and the S&P 500 SPX, +2.38% has advanced 32.4%.
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