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Orphazyme stock plunges after receiving CRL from FDA after review of NPC treatment

Shares of Orphazyme A/S
ORPH,
-45.05%

plummeted 54.3% in premarket trading Friday, after the Denmark-based biopharmaceutical company said overnight that it received a “Complete Response Letter” (CRL) from the U.S. Food and Drug Administration regarding its treatment for Niemann-Pick disease type C (NPC). The CRL said additional qualitative and quantitative evidence was needed to substantiate the validity and interpretation of the 5-domain NPC Clinical Severity Scale and the swallow domain, as well as additional data to confirm evidence beyond the single Phase 2/3 trial supporting the benefit-risk assessment of the New Drug Application (NDA). The company it was “disheartened” and “disappointed” with the FDA’s decision, which will have a “significant influence” on the financial outlook for the year. The company said its guidance range for operating losses has widened to DKK670 million to DKK700 million ($107.4 million to $112.2 million) from DKK100 million to DKK150 million). Orphazyme’s stock made the rounds in social media last week, after the stock skyrocketed as much as 1,387% intraday on June 10 before closing up 301.5% in very volatile trading, even as the company said it was not aware of any reason for the “extreme volatility” in its share price. The stock has advanced 35.7% year to date through Thursday, while the iShares Nasdaq Biotechnology ETF
IBB,
-0.88%

has gained 5.0% and the S&P 500
SPX,
-0.83%

has tacked on 12.4%.

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