Monday, April 16, 2012

Halozyme (Nasdaq: HALO) Falls After FDA Demands More Data: Los Angeles Mover

Halozyme (Nasdaq: HALO) Falls After FDA Demands More Data: Los Angeles MoverShawshank, VA 4/16/12 (StreetBeat) -- Halozyme Therapeutics Inc. (Nasdaq: HALO) fell the most in almost eight years after U.S. regulators requested more information on the company’s blood product used to boost weak immune systems, delaying the treatment’s possible approval.

Halozyme plunged 19 percent to $9.08 at 9:33 a.m. New York time, after declining to $8.32 in its biggest intraday drop since June 2004. The San Diego-based company is developing the injection of immune globulin, used to boost patients’ defense against diseases, with Deerfield, Illinois-based Baxter International Inc. (NYSE: BAX).

Halozyme and Baxter said the U.S. Food and Drug Administration asked for more information about the treatment, known as HyQ. The companies will have to do more studies about long-term use of the drug, and said they also expect to go before an outside panel that advises the FDA.

“The companies expect these requests to require additional time to complete and to delay the companies’ anticipated regulatory review and approval timeline,” Halozyme and Baxter said in a statement today.

HyQ is in the third of three stages of testing usually required for approval by U.S. regulators.

Baxter declined 5.2 percent to $55.01.

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