Halozyme Therapeutics Receives Favorable FDA Decision

Benzinga

Halozyme Therapeutics (NASDAQ: HALO) received notice Thursday that the Blood Products Advisory Committee (BPAC) of the U.S. Food and Drug Administration voted in favor of HyQvia, which it was working with along with Baxter (NYSE: BAX).

The drug treats patients with primary immunodeficiency (PI), and according to the FDA, has a favorable risk/benefit profile. The vote was 15-1; HyQVia was previously approved for use in Europe in 2013.

HyQvia is used in Europe as replacement therapy in adults who have primary immunodeficiency syndromes and in treatment for myeloma or leukemia.

After being halted, Halozyme has resumed trading and was recently up seven percent at $9.90. The shares had traded up to $10.70 on the open, but have since backed off. Given the recent run up in the price of Halozyme, FDA approval may have been priced in to a large degree.

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