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

09 Mar 2018

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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Most Favored Nation Pricing: Trump Ups Pressure On Voluntary Action, Clarifies Demands

01 Aug 2025

• By Sarah Karlin-Smith

The new 60-day deadline for striking a deal with the drug industry underscores the challenges the Administration may be having in developing non-voluntary policies to achieve MFN pricing in the US.

340B Rebate Model Gets HRSA Endorsement; Pilot Program Limited To Medicare Negotiated Drugs

31 Jul 2025

• By Cathy Kelly

Pilot is harbinger of greater transparency in the 340B program. But rebates may only be denied by manufacturers for overlap with Medicare negotiated prices, not for issues like diversion that have driven recent lawsuits.