Pluristem Therapeutics Inc. (NASDAQ: PSTI) is having an incredibly strong time in the pre-market hours this morning, and for good reason. The company announced this morning that the United States Food And Drug Administration has cleared its Investigational New Drug application. Today, we’ll talk about:
- The FDA Clearance;
- what we’re seeing from PSTI as a result;
- and what we’ll be watching for ahead.
FDA Clears PSTI Application
As mentioned above, Pluristem Therapeutics is having an incredibly strong start to the trading session this morning after announcing that the FDA has cleared one of its treatments. In a press release issued early this morning, the company announced that the FDA has cleared its Investigational New Drug application surrounding PLX-R18 cell therapy. The drug was designed for the treatment of acute radiation syndrome, also known as ARS. As a result of the IND, PSTI now has the ability to treat victims who may have been acutely exposed to high dose radiation due to nuclear attack or accident. In the release, the company said that it will start necessary preparations in order to keep an emergency stock of PLX-R18 on hand for use in such events.
According to the IND protocol, PLX-R18 will be provided to patients up to 96 hours following exposure to radiation. The approved dosage for the treatment is 4 million cells per kilogram, with the optimal dosage that was determined in the Phase II-equivalent non-human primate pilot study. During this study, PLX-R18 showed a dramatic increase in survival of population exposed to high doses of radiation. The treatment also showed enhancement of blood lineages recovery. In a statement, Zami Aberman, Chairman and Co-CEO at PSTI, had the following to offer:
We are proud to have PLX-R18 join the exclusive club of IND approved medical countermeasures for the treatment of ARS. This FDA clearance is one of the most significant milestones in the development of PLX-R18 to date and should provide Pluristem with significant support in advancing its off-the-shelf cell therapy into a pivotal trial. The fact that we are now able to treat human casualties in the case of a nuclear event provides us with the ability to protect from severe health consequences, saving lives of population in need.”
What We’re Seeing From The Stock
With the news of the FDA clearance surrounding a Pluristem treatment, it only makes sense that investors are excited this morning. Of course, that excitement can be seen in the movement of the stock in the market this morning. as is almost always the case, our partners at Trade Ideas were the first to alert us to the gains. At the moment (7:49), PSTI is trading at $1.42 per share after a gain of $0.18 per share or 14.52% 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 PSTI. In particular, we’re interested in following the company’s goal of ramping up supplies of PLX-R18 to be held on hand until an event in which it can be used takes place. We’ll also be following the rest of the company’s development of treatments as their pipeline includes more than just this one. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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