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

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Shares of Orphazyme A/S undefined plummeted 54.3% in premarket trading Friday, after the Denmark-based biopharmaceutical company said overnight that it...

Shares of Orphazyme A/S ORPH, -10.18% plummeted 54.3% in premarket trading Friday, after the Denmark-based biopharmaceutical company said overnight that it received a"Complete Response Letter" from the U.S. Food and Drug Administration regarding its treatment for Niemann-Pick disease type C .

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 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.

 

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