HALO Halozyme Therapeutics Incorporated

Edison Investment Research: Halozyme Therapeutics - HyQvia got a favourable vote

The positive vote (15 to one) by the FDA’s Blood Products Advisory Committee (BPAC) for HyQvia should pave the way for its US approval (Q3) and its launch by Baxter, the drug’s commercial partner. Potential risk factors raised and extensively discussed by the FDA at the panel meeting could result in some label restrictions, which will be in line with the drug’s restricted approval in the EU. An FDA approval would remove one near-term risk for Halozyme. The panel vote, though positive, has only a small impact on Halozyme’s valuation, which is now $1,448m, or $11.7 per basic share, vs previously $1,445m, or $11.6 per basic share.

Halozyme Therapeutics focuses on development of extracellular matrix-based drugs. Its rHuPH20-based delivery platform has been used by partners, including Roche, Baxter and Pfizer, to develop SC injection of IV drugs such as Herceptin, Rituxan (Roche) and GAMMAGARD (Baxter). Its pipeline consists of Hylenex, approved for hydration, PEGPH20 in Phase II trials for pancreatic cancer, and HTI-501 in Phase II trials for cellulite.

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