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CTI BioPharma Shares Shoot Higher as FDA Accepts Pacritinib Review Application In Bone Marrow Cancer

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  • The FDA has accepted for review CTI BioPharma Corp's (NASDAQ: CTIC) marketing application seeking approval for pacritinib in myelofibrosis patients with severe thrombocytopenia (low platelet count).

  • 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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