Catalyst Biosciences up 13% premarket on positive FIX data

Catalyst Biosciences (NASDAQ:CBIO) announces positive results from an open-label Phase 2b clinical trial evaluating its next-generation Factor IX (FIX) therapy, Dalcinonacog Alfa (DalcA), in six patients with severe hemophilia B. The data were presented at EAHAD in The Hague.

28 days of daily subcutaneous dosing with DalcA showed FIX levels of more than 12% with steady-state levels up to 27% after 14 days with no bleeds. [For comparison purposes, FIX levels are <1% in people with severe hemophilia B].

No anti-drug antibodies were detected and no serious adverse events were reported. Three subjects experienced injection site reactions, the majority (n=2 in this case, apparently) being mild and resolved without consequences.

Pharmacokinetic and pharmacodynamic data supporting the use of its subcutaneous FVIIa marzeptacog alfa (activated) (MarzAA) in acute or on-demand settings were also presented.

Shares up 13% premarket on light volume.

https://seekingalpha.com/news/3539622-catalyst-biosciences-up-13-premarket-on-positive-fix-data