Athenex stock plunges to track all declines after disappointing FDA response to NDA breast cancer treatment
Shares of Athenex Inc. ATNX,
fell 54.6% on the very active afternoon trading Monday, enough to be the largest listed declining on major U.S. exchanges, after the Food and Drug Administration declared the new drug application (NDA ) from the biopharmaceutical company for its treatment of metastatic breast cancer, oral paclitaxel plus enequidar, is not ready for approval in its current form. Trading volume climbed to 40.1 million shares, from a daily average of around 1.1 million shares. The company said earlier that the FDA had issued a Full Response Letter (CRL) expressing concerns about a risk to patient safety and recommended that a new clinical trial be conducted. Separately, the company reported a fourth quarter net loss that extended to $ 49.5 million, or 53 cents per share, from $ 21.7 million, or 28 cents per share, during the period of the previous year, larger than the FactSet consensus for one share per share. loss of 44 cents. Revenue fell 36.5% to $ 21.8 million, beating 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,
climbed 40.2% and the S&P 500 SPX,
grew by 32.4%.