CTI BioPharma Corp. (NASDAQ: CTIC) is a commercial-stage biopharmaceutical company, which is focused on the research, acquisition, development, and commercialization of novel therapies for blood cancers. Shares of the biopharma company are jumping 43% through early trading on Tuesday, March 1, 2022. Over the past three months, CTI BioPharma has seen average daily volume of 2.11 million shares. However, volume of 56.28 million shares or dollar volume of around $150.27 million, has already exchanged hands through early trading.
Shares of CTI BioPharma are rallying after the company announced that the U.S. Food and Drug Administration has given accelerated approval of VONJO for the treatment of myelofibrosis and thrombocytopenia in adult patients. The approval makes VONJO the first approved therapy specifically to treat adult cytopenic myelofibrosis patients.
The FDA granted accelerated approval for VONJO after reviewing the efficacy results from the pivotal Phase 3 PERSIST-2 study in patients with myelofibrosis. Patients were randomly given VONJO 200mg twice daily (BID), VONJO 400mg once per day (QD), or the best available therapy (BAT). “In this study, in the cohort of patients with baseline platelet counts below 50 × 109/L who were treated with pacritinib 200 mg BD, 29% of patients had a reduction in spleen volume of at least 35% compared to 3% of patients receiving best available therapy, which included ruxolitinib,” according to CTI BioPharma’s press release.
As a condition of its accelerated approval, CTI BioPharma will be required to provide clear clinical benefits in a confirmatory trial. To complete this, the company says they expect to complete the PACIFICA trial with results sometime in mid-2025.
The FDA approval of VONJO also triggers a $60 million royalty from DRI Healthcare Trust, based upon the terms of its debt and royalty transaction. The proceeds are set to be used to help fund the official launch of VONJO.
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