CTI BioPharma Corp. (CTIC) stock soared 42.63% in the current-market trading session at the price of $2.71 after FDA approved VONJO (Pacritinib) to treat Thrombocytopenia and Myelofibrosis. CTIC is a biopharmaceutical firm that develops and commercializes novel drugs to treat blood cancers. The company’s therapies provide a unique advantage to healthcare officials, patients, and families.
FDA Approved VONJO (Pacritinib)
On 28th February 2022, CTIC announced the approval of VONJO by the food and drug administration. Pacritinib treats patients of medium/high-risk myelofibrosis having a platelet lower than 50 × 109/L. VONJO is a unique kinase inhibitor with specificity for IRAK1 and JAK2 without impeding JAK1. The proposed oral dose of VONJO is 200-milligrams two times a day. It is the first approved treatment that specifically treats cytopenic myelofibrosis patients.
The approval had based on the effectiveness of results from the PERSIST-II VONJO study in myelofibrosis patients. As part of the approval, CTIC had directed to demonstrate a clinical benefit in a confirmatory trial. To accomplish this requirement, CTI had scheduled to conclude the PACIFICA trial with desired results by mid of 2025.
The common side effects from VONJO 200 milligrams dosage were thrombocytopenia, diarrhea, anemia, nausea, and peripheral edema. The frequent adverse reactions after VONJO 200 milligram dosage were anemia, pneumonia, thrombocytopenia, disease progression, cardiac failure, and pyrexia.
Chief executive officer of CTIC, Adam R. Craig, commented that there are around 21,000 patients in the United States with myelofibrosis. After the accelerated approval of VONJO, they are ready to deliver this novel therapy commercially. After their royalty and debt transactions with DRI, they are now fully funded for its commercial launch.
Adam added that they look onwards to offering VONJO to adult patients within ten days. He thanked the caregivers, patients, investigators, and clinical trial staff who made clinical trials possible. He also appreciated the CTIC team for their dedication, hard work, and focus on patient needs.