Shares of Xenetic Biosciences Inc XBIO, a drug delivery platform company, were ripping higher Wednesday on markedly above-average volume.
What Happened: The Framingham, Massachusetts-based company said its partner and Russian biopharma PJSC Pharmsynthez reported positive data from a pivotal Phase 3 study of Epolong that used Xenetic's PolyXen to develop a treatment for anemia in patients with chronic kidney disease.
PolyXen is Xenetic's patent-protected platform technology designed for prolonging a biologic drug's circulating half-life and potentially improving other pharmacological properties.
Pharmsynthez's late-stage study being conducted in Russia is evaluating the safety and tolerability of Epolong, a polysialylated form of recombinant human erythropoietin — a hormone produced by the kidneys to promote blood cell production — in comparison with Amgen, Inc.'s AMGN Aranesp.
The results of the study indicated that Epolong was non-inferior to Aranesp with respect to primary and secondary endpoints, with the proportion of patients achieving target hemoglobin range being 74% in the Epolong group versus 52% in the Aranesp group.
"The PolyXen platform continues to demonstrate broad utility and ability to modulate the pharmacokinetic and pharmacodynamic profiles of protein drugs," said Jeffery Eisenberg, CEO of Xenetic.
Why It's Important: Apart from Pharmsynthez, Xenetic has R&D as well as license and supply agreements with Takeda Pharmaceutical Co Ltd TAK, the Serum Institute of India and SynBio, a wholly owned subsidiary of Pharmsynthez.
What's Next: Xenetic said it now looks forward to the outcome of Pharmsynthez's registration filing in Russia for Epolong, which is expected in 2021.
XBIO Price Action: Xenetic shares were soaring 212.96% to $3.38 ahead of the close Wednesday.
Related Link: Attention Biotech Investors: Mark Your Calendar For December PDUFA Dates
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