Thursday, June 21, 2012

Reuters: Global Markets: Onyx shares soar on favorable FDA panel vote

Reuters: Global Markets
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Onyx shares soar on favorable FDA panel vote
Jun 21st 2012, 11:52

Thu Jun 21, 2012 7:52am EDT

(Reuters) - Shares of Onyx Pharmaceuticals Inc (ONXX.O) jumped more than 40 percent in premarket trade after a U.S. advisory committee recommended Onyx's drug for blood cancer patients who did not respond to other medicines.

The panel of independent experts advising the U.S. Food and Drug Administration unanimously voted to recommend approval of Onyx's drug Kyprolis. The FDA will make a final decision by July 27.

"We think it is increasingly likely the FDA will grant accelerated approval for Kyprolis in July," Barclays analyst Ying Huang said in a note.

Several brokerages including Barclays, Jefferies, Baird and Deutshe Bank raised their price target on the stock.

"While we remain unclear that carfilzomib (Kyprolis) will receive approval by its July 27 PDUFA (action date) as there's a possibility of an administrative extension, we believe it can receive approval in the second half of 2012," Jefferies and Co analyst Biren Amin said in a note to clients.

Kyprolis is proposed to treat patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy.

Multiple myeloma is a type of cancer that affects the plasma cells in bone marrow.

The South San Francisco, California-based company's shares were up 40 percent at $62.35 in premarket trade. They closed at $44.58 on Wednesday on the Nasdaq.

(Reporting by Prateek Kumar in Bangalore; Editing by Roshni Menon)

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