CTI BioPharma (NASDAQ:CTIC) news for Wednesday includes plans to submit a new drug application (NDA) sending CTIC stock soaring higher.
According to a news release from CTI BioPharma, the company is preparing to submit its NDA for pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia. The company notes that this comes after a successful pre-NDA meeting with the U.S. Food and Drug Administration (FDA).
CTI BioPharma notes that the FDA has agreed to a rolling NDA submission. The company expects to make its submission in the fourth quarter of 2020. It’s then looking for it to reach completion in the first quarter of 2021.
CTI BioPharma says that its NDA for pacritinib is supported by its Phase 3 Persist-1 and Persist-2 trials, as well as its Phase 2 PAC203 dose-ranging trial. The company also points out that it will complete its ongoing Phase 3 Pacifica trial after the treatment makes it to market.
Adam Craig, M.D., Ph.D., president and CEO of CTI BioPharma, said this about the news.
“In myelofibrosis patients, severe thrombocytopenia occurs as a result of disease or drug-related toxicity from current therapies. There is no approved drug that specifically addresses the unmet need of the myelofibrosis patients who have severe thrombocytopenia. Pacritinib has demonstrated clinical benefit in treating these patients in multiple trials and now has the potential to become a new treatment option for treatment-naïve and second-line myelofibrosis patients in 2021.”
CTIC stock was up 104.3% as of Wednesday afternoon.
On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article.