BioMarin's Stock Falls After FDA Says It's Not Ready To Approve NDA For MS Drug

By Markets MarketWatch Pulse

BioMarin Pharmaceutical Inc.'s stock fell 2.5% in premarket trade Thursday, after the biotechnology company said the Food and Drug Administration would not be approving its new drug application (NDA) for its muscular dystrophy treatment Kyndrisa. The FDA said in its "complete response" letter to the NDA that the standard substantial evidence of effectiveness has not been met. BioMarin said it will work with the FDA to determine the next steps it needs to take. The stock has tumbled 19% over the past three months, while the iShares Nasdaq Biotechnology ETF has lost 7.1% and the S&P 500 has slipped 5.2%.

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