CTI BioPharma Corp (fka CTIC)

[ctb]

CTI BioPharma (CTIC) Stock: Falling On Clinical Update

http://cnafinance.com/cti-biopharma-ctic-stock-falling-on-clinical-update/19895

CTI Biopharma CTIC STock NewsCTI BioPharma Corp (NASDAQ: CTIC) is having a rough start to the trading session in the pre-market hours this morning after announcing the results of a Type B meeting with the FDA. While the meeting outlined a path toward approval, the stock is falling dramatically.

In a press release issued early this morning, the company announced that it recently conducted a Type B meeting with the United States Food and Drug Administration surrounding its lead product, pacritinib.

During the meeting CTIC and the FDA discussed the regulatory pathway for the treatment. In the release, the company said that based on feedback from the FDA, it plans on conducting a randomized phase 3 study of pacritinib in patients with myelofibrosis. The dosing of the study will be determined using the results of the PAC203 Phase 2 clinical study. The company expects that enrollment will be completed by 2018 with full top-line data expected in the second quarter of 2019.

In a statement, Adam R. Craig, M.D., Ph.D., President and CEO At CTIC, had the following to offer:

"We have received the clarity we requested from the FDA on a regulatory path to possible approval in the U.S., and look forward to using all available data, including pharmacokinetic analyses, to select the optimal dose for a new Phase 3 study… The new study is expected to address the unmet medical needs of patients with myelofibrosis, particularly those with severe thrombocytopenia. We plan to request an additional meeting with the FDA, after the second interim analysis, to discuss interim data from PAC203 and the design of the new Phase 3 study."

So, why is the stock falling? While the FDA did provide a path toward approval for the treatment, there are some concerns with timeline. Ultimately, investors were hoping that the current clinical study would be enough to move forward with an NDA should the study results be positive. However, with a Phase 3 trial required, investors are a little upset. Nonetheless, this may be presenting an opportunity as the IDMC did not find any drug-or-dose related safety concerns. Therefore, while a Phase 3 study will be required before the company can submit its NDA, that is the general course of action, and overall, things look positive.


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