Clovis Oncology Inc (NASDAQ:CLVS)

Clovis Oncology Inc (NASDAQ:CLVS), a biopharmaceutical company, focuses on acquiring, developing, and commercializing anti-cancer agents in the United States, Europe, and internationally. It is developing three product candidates which comprise Rociletinib, an oral epidermal growth factor receptor and mutant-selective covalent inhibitor that is in advanced clinical development for the treatment of non-small cell lung cancer; Rucaparib, an oral inhibitor of poly polymerase, which is in advanced clinical development for the treatment of ovarian cancer; and Lucitanib, an oral inhibitor of the tyrosine kinase that is in Phase II development for the treatment of breast and lung cancers.

News Update:

Clovis Oncology, Inc. (CLVS) declared that during its regularly planned Mid-Cycle Communication Meeting held last week with the U.S. Food and Drug Administration (FDA), the agency requested additional clinical data for use in the efficacy analysis for both the 500mg and 625mg BID dose patient groups for rociletinib. The Company will provide this information in a Major Amendment to the FDA by close of business recently.

“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. “We will continue to work diligently with the FDA on our NDA submission.”

In the Mid-Cycle Communication meeting, the FDA emphasized that its efficacy analysis would focus solely on confirmed responses. The New Drug Application (NDA) presented by Clovis to the FDA contained immature data sets based on both unconfirmed response rates and confirmed response rates. These data sets were updated in the 90 day efficacy update the Company presented at the end of October.

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.

Shares of Clovis Oncology Inc (NASDAQ:CLVS), dropped -68.50% and is at $31.32 in the Real-Time trading session. The firm opened its current trade at $29.27. The total volume traded for the day is 14.46M shares, as compared to its average daily volume of 734,150.00 shares. The stock is floating in a range of $26.05 - $35.93. The stocks hold the market capitalization of $1.20B.

The mean estimate for the short term price target for Clovis Oncology Inc (NASDAQ:CLVS), stands at $118.83 according to 6 Analysts. The higher price target estimate for the stock has been calculated at $140.00 while the lower price target estimate is at $92.00.

Analysts mean recommendation for the stock is 2.00. This number is based on a 1 to 5 scale where 1 indicates a Strong Buy recommendation while 5 represents a Strong Sell.

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