Clovis Oncology (CLVS) Stock Plunging On Anticipated Delay in FDA Drug Approval
NEW YORK (TheStreet) -- Clovis Oncology (CLVS) - Get Report stock is plummeting by 68.56% to $31.26 in late morning trading on Monday, after the U.S. Food and Drug Administration delayed approval of the company's lung cancer drug.
During the bio-pharmaceutical company's mid-cycle communication meeting with the FDA last week, the regulatory agency asked for additional clinical data regarding a lung cancer drug under clinical trial, according to a company statement.
The patients under the trial were taking two different dosages of rociletinib, one of Clovis' three products under development.
The review of this additional information will likely result in a delay of potential approval, Clovis noted.
"We remain confident in rociletinib and its potential to treat patients with mutant EGFR T790M-positive lung cancer, said CEO Patrick J. Mahaffy said in a statement today. "We will continue to work diligently with the FDA on our NDA submission."
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