Halozyme jumps after FDA lifts hold on subcutaneous Cinryze

Halozyme Therapeutics Inc. (NASDAQ:HALO) jumped $1.54 (24%) to $7.95 on Friday after it and partner ViroPharma Inc. (NASDAQ:VPHM) said FDA lifted a clinical hold on a Phase II trial of subcutaneous Cinryze in combination with Halozyme's recombinant human PH20 hyaluronidase ( rHuPH20) for hereditary angioedema (HAE). The partners said they can restart the Phase II trial of the product after they submit a revised protocol to allow for increased monitoring of rHuPH20 antibody levels.

FDA placed the hold in July after raising concerns in a complete response letter for a BLA for subcutaneous HyQ from Halozyme's partner Baxter International Inc. (NYSE:BAX) to treat primary immunodeficiency disorder (PID). FDA had concerns about non-neutralizing antibodies generated against rHuPH20, which is also a component in HyQ. According to the partners, the agency said it believes the concerns about the antibodies are limited to subcutaneous HyQ (see BioCentury Extra, Aug. 1). ...