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Under the Priority Review, the agency's target action date is November 30, 2021.
The FDA is not planning to hold an advisory committee meeting to discuss the application.
The acceptance was based on the Phase 3 PERSIST-2 and PERSIST-1 and the Phase 2 PAC203 clinical trials.
In the PERSIST-2 study, in patients with severe thrombocytopenia treated with pacritinib 200 mg twice a day, 29% of patients had a reduction in spleen volume of at least 35%, compared to 3% of patients receiving the best available therapy, which included ruxolitinib.
23% of patients had a reduction in total symptom scores of at least 50%, compared to 13% of patients receiving the best available therapy.
Price Action: CTIC shares are up 7.53% at $2.57 during the market session on the last check Tuesday.
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