CTI BioPharma Corp (NASDAQ:CTIC) provided an update regarding the clinical studies being conducted under the Company’s Investigational New Drug (“IND”) application for pacritinib. Following the issuance of the Company’s February 8, 2016, press release describing the partial clinical hold issued by theU.S. Food and Drug Administration (FDA) regarding those clinical studies, the Company received an oral communication from the FDA followed by a letter notifying the Company that the Company’s IND for pacritinib has been placed on full clinical hold. The Company has withdrawn its New Drug Application (NDA) until the Company has had a chance to review the safety and efficacy data from the PERSIST-2 Phase 3 clinical trial and decide next steps.
The FDA’s February 8, 2016, letter notes the interim overall survival results from PERSIST-2 show a detrimental effect on survival consistent with the results from PERSIST-1. The deaths in PERSIST-2 in pacritinib-treated patients include intracranial hemorrhage, cardiac failure and cardiac arrest. The FDA made recommendations that supersede the recommendations made by the FDA in connection with the partial clinical hold imposed by the FDA on February 4, 2016. The current recommendations include conducting dose exploration studies for pacritinib in patients with myelofibrosis, submitting final study reports and datasets for PERSIST-1 and PERSIST-2, providing certain notifications, revising relevant statements in the related Investigator’s Brochure and informed consent documents and making certain modifications to protocols. In addition, the FDA recommended that the Company request a meeting prior to submitting a response to full clinical hold.
Under the full clinical hold, all patients currently on pacritinib must discontinue pacritinib immediately and no patients can be enrolled or start pacritinib as initial or crossover treatment.
All clinical investigators worldwide have been delivered a notice of the full clinical hold. (Original Source)
Shares of CTI BioPharma closed yesterday at $0.50. CTIC has a 1-year high of $2.94 and a 1-year low of $0.49. The stock’s 50-day moving average is $1.17 and its 200-day moving average is $1.41.
On the ratings front, CTIC has been the subject of a number of recent research reports. In a report issued on February 8, Piper Jaffray analyst Charles Duncan maintained a Buy rating on CTIC, with a price target of $4, which implies an upside of 700.0% from current levels. Separately, on November 9, WallachBeth Capital LLC’s Bob Ai downgraded the stock to Hold and has a price target of $1.60.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Charles Duncan and Bob Ai have a total average return of -13.6% and -18.7% respectively. Duncan has a success rate of 26.6% and is ranked #3450 out of 3560 analysts, while Ai has a success rate of 20.0% and is ranked #3112.