CTI BioPharma (CTIC) PT Lowered to $5 at Needham & Company on PDUFA Delay

Needham & Company analyst Gil Blum lowered the price target on CTI BioPharma (NASDAQ: CTIC) to $5.00 (from $6.00) while maintaining a Buy rating after FDA has extended the PDUFA action date for approval of pacritinib in thrombocytopenic myelofibrosis (MF) patients by 3 months to February 28, 2022.

The analyst commented, "CTI received notification requesting additional clinical information on November 24th during correspondence with the agency over the drug label. The FDA considers the data submission to constitute a "major amendment" to the NDA and will require additional time to review the submission. However, the agency has not requested any additional information. We remain positively biased towards pacritinib approval based on its efficacy in thrombocytopenic MF and the lack of therapeutic options for these patients. However, this delay will postpone a potential launch. To account for the change in timelines we are reducing our price target from $6 to $5."

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