Pluristem Therapeutics (PSTI) Stock: Gaining On Orphan Drug Designation

Pluristem Therapeutics Inc. (NASDAQ: PSTI) is having an incredibly strong start to the trading session in the pre-market hours this morning, and for good reason. The company announced great news that it has received from the FDA, leading to excitement among investors and gains in the value of the stock. Of course, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:11), PSTI is trading at $1.87 per share after a gain of $0.13 per share or 7.47% thus far today.

PSTI Announces Positive FDA News

As mentioned above, Pluristem Therapeutics is having an incredibly strong start to the trading session in the pre-market this morning after the company announced overwhelmingly positive FDA news. According to a press release issued by the company early this morning, the United States Food and Drug Administration has granted PSTI an orphan drug designation for its PLX-R18 cell therapy. The treatment was designed for the prevention and treatment of acute radiation syndrome.

Recently, the company reported positive data from non-human primate studies surrounding the treatment. These studies were conducted by the National Institute of Allergy and Infectious Diseases. The data showed incredibly positive news as the treatment demonstrated improved survival rates and the enhancement of recovery across all 3 major blood lineages. Also, PLX-R18 cells are being studied by the United States Department of Defense’s Armed Forces Radiology Research Institute. The goal of this study is to examine the effectiveness of the cells as a treatment for ARS prior to and within 24 hours of exposure to radiation. However, that’s not all. The PLX-R18 cells developed by PSTI are also being studied by Fukushima Medical University in Japan. This study is focused on the treatment of ARS and PLX-R18 cells as an adjunct to radiotherapy in cancer patients. In a statement, Zami Aberman, Co-CEO and Chairman at PSTI, had the following to offer:

Pluristem has a vast and dynamic program developing our PLX-R18 therapy as a treatment for ARS, which can potentially save many lives… Receiving Orphan Drug Designation brings us one step closer to providing a next-generation medical countermeasure against ARS, which is especially important given today’s volatile political climate.”

What Orphan Drug Designation Means

Orphan Drug Designation is overwhelmingly positive news for Pluristem Therapeutics as it comes with various developmental benefits. First and foremost, there are tax credits that come along with the designation. There is also the avoidance of some fees associated with the regulatory approval process and an expedited process. So essentially, Orphan Drug Designation will make it less expensive to bring PLX-R18 to the market while expediting the process.

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will continue to follow PSTI incredibly closely. In particular, we’re interested in following the ongoing development of PLX-R18 as well as the rest of the company’s robust pipeline. Nonetheless, we’ll continue to follow the story and bring the news to you as it breaks!

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