CTI BioPharma: FDA Extends Review Period For Pacritinib For Treatment Of Myelofibrosis; Stock Down

(RTTNews) - CTI BioPharma Corp. (CTIC) said that the U.S. Food and Drug Administration has extended the review period for the New Drug Application or NDA for pacritinib for the treatment of adult patients with intermediate or high-risk primary or secondary myelofibrosis or MF with a baseline platelet count of <50 × 109/L.

The Prescription Drug User Fee Act (PDUFA) action date has been extended by three months to February 28, 2022.

CTIC closed Tuesday regular trading at $2.25 down $0.41 or 15.41%. In the after-hours, the stock further dropped $0.42 or 18.67%.

The FDA had granted priority review for CTI's NDA for patients with myelofibrosis with a PDUFA date of November 30, 2021.

In the course of product labeling discussions, the FDA requested additional clinical data, which was submitted to the agency on November 24, 2021.

Earlier today, the FDA informed the company that it considers the data submission to constitute a "major amendment" to the NDA and therefore the PDUFA date has been extended by three months to provide additional time for a full review of the submission.