Alkermes PLC ALKS, -22.55% shares tumbled 21.5% in premarket trade Monday after the company received a "refusal to file" letter from the Food and Drug Administration regarding its new drug application for ALKS 5461, a treatment for major depressive disorder (MDD). Alkermes said the FDA has taken the position that it is unable to complete a substantive review of the NDA given insufficient evidence of overall effectiveness, and said additional clinical trials are needed before the NDA is resubmitted. Alkermes said it "strong disagrees" with the FDA and will appeal its decision. "We are extremely disappointed with this decision and the implications for patients in the U.S. suffering from major depressive disorder, a serious disease where there is a clear and urgent need for new treatment options for patients and their families," said Alkermes Chief Executive Richard Pops. The company said it is evaluating the impact of the FDA's decision on previously provided financial guidance. The stock had gained 5.0% over the past three months through Thursday, while the iShares Nasdaq Biotechnology ETF IBB, -4.61% had lost 2.4% and the S&P 500 SPX, -2.94% has slipped 2.0%.
Read the full story: Alkermes execs say they’re flummoxed by embarrassing FDA drug refusal; stock plunges