Update: 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 is a biopharma technology platform company that provides solutions to improve patient experience and outcomes. The company's approved product and its collaborators' approved products and product candidates are based on rHuPH20, its patented recombinant human hyaluronidase enzyme. The company refers to the application of rHuPH20 to facilitate the delivery of other drugs or fluids as its ENHANZE? Drug Delivery Technology (ENHANZE). The company licenses the ENHANZE technology to form collaborations with biopharmaceutical companies that develop or market drugs requiring or benefiting from injection via the subcutaneous route of administration.
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