CTI BioPharma is up 11.5% after the company said the PIX306 confirmatory trial of its commercial product PIXUVRI (pixantrone) continues to progress toward an announcement of top-line results later this year.
If positive, the trial could provide the opportunity for full approval and label expansion by EMA, and discussions with the FDA about accelerated PIXUVRI approval in the US to treat patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma.
In January, it noted the FDA removed the full clinical hold on studies under the IND application for pacritinib, and the company received a 7.5-million euro milestone payment for Servier following a milestone associated with patient enrollment in the Phase 3 PIX306 tiral of Pixuvri.
This year, it expects to advance its marketing authorization application in the E.U. and define a regulatory pathway in the U.S. for pacritinib; initiate in Q2 a PAC203 trial; and secure ex-U.S. partner for pacritinib.