CTI BioPharma is having a great day in the market today after announcing that it plans to submit a New Drug Application to the United States Food and Drug Administration. Today, we’ll talk about what the NDA is for, when CTIC plans to submit the NDA, how the market reacted to the news, and what we can expect to see moving forward. So, let’s get right to it…
CTIC Will Submit An NDA For Pacritinib
CTI BioPharma announced today that it plans on submitting a new drug application for pacritinib. The company has had a productive pre-NDA meeting and feels as though it is ready to push the drug to the market. Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. According to today’s announcement, CTIC will be requesting accelerated approval for the treatment of patients with intermediate and high-risk myelofibrosis with low platelet counts of less than 50,000 per microliter. The submission of the NDA is expected to happen in the fourth quarter of 2015 and is based primarily on data from the PERSIST-1 Phase 3 clinical trial as well as data collected from Phase 1 and Phase 2 studies of the drug. Myelofibrosis is a rare, yet serious chronic blood cancer that affects patients of all ages, however, the median age of patients is 65 years old. In the United States, it is estimated that 18,000 patients are currently living with this condition. During the announcement, James A. Bianco, M.D., President and CEO of CTIC had the following to say…
“This improved timing on the plan to submit an NDA, which is supported by data after completion of the PERSIST-1 trial, will allow us the potential for making pacritinib available to patients with low platelet counts earlier than expected… We look forward to working with the FDA on the submission and review of this application.”
How The Market Reacted To The News
As we’ve come to expect anytime positive news is released with regard to a biotechnology company, CTIC is climbing in the market today, even though the market is struggling yet again. Currently (1:08), CTIC is trading at $1.57 per share after a gain of 9.03% so far today.
What We Can Expect To See Moving Forward
Moving forward, I’ve got an overwhelmingly bullish opinion of what we can expect to see from CTIC. Ultimately, pracritinib has proven through three phases of studies to be effective in treating myelofibrosis, leading to a new drug application. Based on my research, I see no reason why the new drug application would be declined. Therefore, we have a few catalysts to look forward to ahead. First and foremost, I’m expecting to see more massive gains on the day of and day after the NDA submission to the FDA. Also, I’m expecting more gains upon the approval of the drug. While there are always down points during uptrends, I would imagine that we are going to see an overall uptrend on the stock between now and the approval of the NDA. From there, it will be all about sales; I see no reason for CTIC to struggle in that area considering the data that is available.
What Do You Think?
Where do you think CTIC is headed and why? Let us know in the comments below!
[Image Courtesy of LinkedIn]