Clovis Oncology Plunges 70% In A Day: What Happened?

Shares of Clovis Oncology Inc CLVS plunged more than 70 percent on Monday, establishing a new multi-year low of $26.05.
Shares of Clovis were initially halted early Monday morning as the company reported that the FDA submitted a request for additional information on the company's lung cancer drug.
Clovis' CEO Patick Mahaffy said that he remains "confident" in the drug and its "potential to treat patients."

Shares of Clovis Oncology plunged more than 70 percent on Monday after the company announced that the US Food and Drug Administration (FDA) submitted a request for additional clinical data for use in the efficacy analysis for the company's 500mg and 625mg BID dose patient groups for rociletinib. According to Clovis'

website, "Rociletinib (CO-1686) is a novel, oral, targeted covalent (irreversible) inhibitor of the cancer-causing mutant forms of epidermal growth factor receptor (EGFR) currently being studied for the treatment of non-small cell lung cancer (NSCLC). Rociletinib was designed to selectively target both the initial activating EGFR mutations and the dominant acquired T790M resistance mutation, while sparing wild-type, or normal EGFR at anticipated therapeutic doses, with an improved toxicity profile." Shares of Clovis were halted during Monday's pre-market trading session for approximately half an hour. When the stock resumed for trading at around 8:30, investors and traders drove the stock lower by 60 percent. Clovis' stock traded as low as $26.05 shortly after Monday's opening bell. The last time the stock traded at this level was March 2013. However, the stock rebounded from its lows and was trading at $34.36 by 10:15AM. "We remain confident in rociletinib and its potential to treat patients with mutant EGFR T790M-positive lung cancer, said Patrick J. Mahaffy, President and CEO of Clovis Oncology in a

press release

. "We will continue to work diligently with the FDA on our NDA submission." The company added in the press release: "In the intent to treat analysis of the 79 patients in the 500mg dose group, the current confirmed response rate is 28 percent, and 34 percent in the 170 patients in the 625mg dose group, with an encouraging duration of response in both doses. The most frequent reasons that patients' responses were not confirmed in a subsequent scan were due to progression, often due to brain metastasis, and due to subsequent scans not demonstrating tumor shrinkage greater than 30 percent." The company also noted that the additional review could lead to an extension of the company's March 30, 2016 Prescription Drug User Fee Act (PDUFA) date.

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