FDA: CTI BioPharma Must Conduct A Third Pacritinib Phase 3 Study

Today, the FDA requested a third CTI BioPharma Pacritinib phase 3 study. Usually, getting approval from the FDA to start a phase 3 clinical trial on a drug is a good thing. It’s not a good thing, however, when it is the third phase 3 clinical study conducted on the same drug.

Why? Well, because this suggests, for the most part, that the drug isn’t ready to enter the market, despite getting as far as a phase 3 study.

On the news, the CTI BioPharma stock dropped, ending the day down more than 40%.

CTI BioPharma Pacritinib: Back to the Drawing Board

There are two problems, in particular, with the FDA asking the Seattle, Washington-based company to conduct another phase 3 clinical study for Pacritinib, its myelofibrosis drug.

Problem #1: 3rd Time’s the Charm?

First, CTI BioPharma has already completed two phase 3 studies on the drug, which is intended to treat myelofibrosis, a dangerous bone marrow disorder.

Because the FDA has asked for another CTI BioPharma phase 3 on Pacritinib, the drug’s potential approval date is delayed, which might explain today’s more than 40% stock drop.

Or, the CTI BioPharma stock plunged as much as it has Wednesday because of sheer investor disappointment. With the PAC203 phase 2 clinical study, investors were hoping the FDA would think that was enough to approve Pacritinib. That, as we now know, is not the case.

Problem #2: Phase 3 Won’t Start Until Next Year

The FDA has asked for another study, but it won’t be able to start until next year, which puts a massive dent in the company’s plans.

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Dosing for the new study will be defined by the results from the company’s current PAC203 phase 2 study of the drug.

And this is a problem because this study isn’t over yet, and won’t be until the end of this year. Hence why the new phase 3 study for CTI BioPharma Pacritinib won’t start until 2019.