CTI BioPharma : FDA Approves VONJO To Treat Myelofibrosis And Thrombocytopenia In Adults

CTI BioPharma Corp. (CTIC) said Monday that the U.S. Food and Drug Administration has approved VONJO or pacritinib for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L. The recommended dosage of VONJO is 200 mg orally twice daily.

CTIC closed Monday regular trading at $1.90, down $0.47 or 19.83%. But in the after hours trade, the stock gained $0.20 or 10.53%.

VONJO is a novel oral kinase inhibitor with specificity for JAK2 and IRAK1, without inhibiting JAK1.

VONJO is the first approved therapy that specifically addresses the needs of patients with cytopenic myelofibrosis, the company said in a statement.

The most common adverse reactions following VONJO 200 mg twice daily were diarrhea, thrombocytopenia, nausea, anemia and peripheral edema.

The most frequent serious adverse reactions following VONJO 200 mg twice daily were anemia, thrombocytopenia, pneumonia, cardiac failure, disease progression, pyrexia and squamous cell carcinoma of skin.

As per the terms of the previously announced debt and royalty transaction with DRI Healthcare Trust, the FDA approval of VONJO triggers the acquisition by DRI of a tiered royalty on VONJO for US$60 million. CTI will use the proceeds of the transactions to fund the launch of VONJO.

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