Ziopharm Oncology Inc. (NASDAQ: ZIOP) is making a run for the top in the pre-market hours this morning, and for good reason. The company announced that it has received Fast Track Designation from the FDA, exciting investors and sending the stock on a run for the top. Today, we’ll talk about:
- The Fast Track Designation;
- what we’re seeing from ZIOP stock as a result; and
- what we’ll be watching for ahead.
ZIOP Announces Fast Track Designation
As mentioned above, Ziopharm Oncology is having a great day in the market today after the company announced that it has received Fast Track Designation from the FDA. The announcement came early this morning by way of press release.
In the release, ZIOP said that the Designation was granted for its Controlled IL-12 program, or AD-RTS-hIL-12 plus veledimex. The treatment is being developed as an option for recurrent or progressive glioblastoma multiforme (rGMB) in adults.
Previously, data that was presented suggests that Ad-RTS-hIL-12 with 20mg veledimex improves the median overall survival (mOS) from 6 to 9 months seen with available therapies to 12.7 months. The company also said that the data suggests further improvement in mOS to 17.8 months in a subset of subjects with reduced cumulative steroid exposure during the active dosing period of veledimex.
The Fast Track Designation is great news as it helps to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Drugs granted Fast Track Designation are eligible for various benefits, including the potential for Accelerated Approval.
In a statement, Laurence Cooper, M.D., Ph.D., CEO at ZIOP, had the following to offer:
Recurrent glioblastoma multiforme is an aggressive and life-threatening cancer of the central nervous system for which there are few treatment options and no cure. We are pleased the FDA has granted Fast Track designation and continue to believe this investigational drug has the potential to safely harness the power of interleukin-12, which in turn activates the patient’s own immune system to attack this cancer and extend overall survival.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to work in the market is that the news leads to moves. When it comes to Ziopharm Oncology, the news proved to be overwhelmingly positive.
After all, the Fast Track Designation opens the door to more frequent meetings with the FDA and further support provided by the regulatory body. So, it’s not surprising to see that excited investors are pushing the stock on a run for the top.
As is just about always the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:14), ZIOP is trading at $4.23 per share after a gain of $0.83 per share or 9.87% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on ZIOP. In particular, we’re interested in following the story surrounding the company’s continued work to bring this treatment to market following the Fast Track Designation news. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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