Halozyme, Baxter off as FDA wants more HyQvia data

Shares of Halozyme Therapeutics Inc. (NASDAQ:HALO) and Baxter International Inc. (NYSE:BAX) slid on Monday after FDA told the partners it needs additional information before the agency can complete the review of HyQvia for primary immunodeficiency disorder. According to the partners, FDA requested additional data -- either from clinical or preclinical studies -- on the long-term use of HyQvia, but did not issue a complete response letter. Halozyme fell $2.72 (24%) to $8.56, while Baxter fell $3.93 to $54.10.

The partners expect to discuss the agency's request at a meeting of FDA's Blood Products Advisory Committee, which has yet to be scheduled. A decision on the BLA was expected this quarter, with a launch slated for next half. On Monday, the companies said the expected launch could be delayed beyond 2012, but did not provide details. ...