Portola leaps on large-scale betrixaban study results

Portola Pharmaceuticals’ (Nasdaq: PTLA) stock rose nearly 14% in pre-market trading on Friday, following the full Phase III presentation of the APEX study of betrixaban at the International Society of Thrombosis and Hemostasis (ISTH) meeting in Montpellier, France.

The positive results were welcome news for the US biotech firm, which earlier this year saw its shares tumble 29% to $20.40 after Phase III clinical trial results of its oral blood thinner betrixaban missed study thresholds. Full results from the APEX trial were published simultaneously online in prestigious New England Journal of Medicine (JAMA).

APEX, which enrolled 7,513 patients at more than 450 clinical sites worldwide, assessed the superiority of extended-duration betrixaban for 35 days compared to standard-duration enoxaparin for 10+4 days. The trial was designed in cooperation with the US Food and Drug Administration and European Medicines Agency to incorporate a novel patient enrichment and statistical analysis plan derived from the 2012 FDA guidance document on enrichment strategies for clinical trials.