1. Pink Sheet

CTI's Approval Prospects For Pacritinib In Myelofibrosis Look To Be Improving

 
• By Joseph Haas

Firm publishes final data from a Phase III study showing the safety-troubled JAK2/FLT3 inhibitor performs better than Jakafi in reducing spleen size. Ongoing dose-finding study will determine the regulatory path forward.

CTI BioPharma Corp. sounds optimistic that it can find a regulatory path forward for its safety-troubled pacritinib in myelofibrosis – and market analysts seem to agree – as the Seattle biotech awaits an interim look at a dose-response study intended to illustrate the drug's risk/benefit profile, even though pacritinib missed one of the co-primary endpoints in the final data from the Phase III PERSIST-2 study.

A JAK2/FLT3 inhibitor, pacritinib had already been submitted for approval at both the US FDA and the European Medicines Agency...

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