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What: Shares of biopharmaceutical company Halozyme Therapeutics (NASDAQ:HALO), which engages in human enzyme research, soared as much as 20% after announcing a positive opinion from a European panel over its primary and secondary immunodeficiency drug, HyQvia.
So what: HyQvia, which was developed by Halozyme and Baxter International (NYSE:BAX), received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use (essentially the equivalent of the FDA panel for Europe) as a replacement therapy for adults with primary of secondary immunodeficiencies. HyQvia works as a subcutaneous injection that's given every three to four weeks and could help lower the number of adverse events often associated with more frequent intravenous injections. In trials, HqQvia resulted in an acute serious bacterial infection rate of just 0.025, which is well below the required efficacy threshold of 1.0.
Now what: Just like with the FDA at home, the EMA is not required to follow the opinion of its panel. However, I feel this is a pretty resounding endorsement given its success in clinical trials and the comfort improvement that it could bring patients in terms of a subcutaneous injection compared to intravenous injection. We may have already seen most of the pop should HyQvia be approved in Europe, but with Baxter on its side, I could see HyQvia selling well. This will definitely be a name worth keeping an eye on.
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Fool contributor Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong, track every pick he makes under the screen name TrackUltraLong, and check him out on Twitter, where he goes by the handle @TMFUltraLong.
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