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June 18, 2021, 6:54 a.m. EDT

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

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By Tomi Kilgore

Shares of Orphazyme A/S /zigman2/quotes/221335072/composite ORPH -1.82% 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 /zigman2/quotes/206189322/composite IBB -0.22% has gained 5.0% and the S&P 500 /zigman2/quotes/210599714/realtime SPX +0.66% has tacked on 12.4%.

/zigman2/quotes/221335072/composite
US : U.S.: Nasdaq
$ 4.86
-0.09 -1.82%
Volume: 557,875
July 29, 2021 1:28p
P/E Ratio
N/A
Dividend Yield
N/A
Market Cap
$174.89 million
Rev. per Employee
N/A
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/zigman2/quotes/206189322/composite
US : U.S.: Nasdaq
$ 166.45
-0.36 -0.22%
Volume: 1.17M
July 29, 2021 1:28p
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/zigman2/quotes/210599714/realtime
US : S&P US
4,429.59
+28.95 +0.66%
Volume: 1.15B
July 29, 2021 1:28p
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