Pluristem Therapeutics Inc. (NASDAQ: PSTI) is having an overwhelmingly strong day in the market today, and for good reason. The company announced news from the United States Food and Drug Administration, leading to excitement among investors and sending the stock screaming for the top. Today, we’ll talk about the news, what we’re seeing from the stock, and what we’ll be watching for ahead.
PSTI Gains On FDA News
As mentioned above, Pluristem Therapeutics is having an overwhelmingly strong start to the trading session in the pre-market hours, and for good reason. The company issued a press release this morning, informing investors of FDA news. According to the press release, the FDA has cleared the company’s Expanded Access Program for the use of its PLX-PAD cell treatment in patients with Critical Limb Ischemia, also known as CLI.
The expanded access program allows for the use of an investgational medication outside of clinical trials. This is generally granted in cases where patients are unsuitable for inclusion under the study protocol and the patient’s condition is life-threatening with an unmet medical need.
In the release, PSTI said that, as part of the program, PLX-PAD cell therapy will be made available to a limited number of Rutherford Category 5 CLI patients in the United States who are unsuitable for revascularization and cannot take part in the company’s ongoing Phase III clinical study. In a statement, Yaky Yanay, Co-CEO and President at PSTI, had the following to offer:
“This is a true vote of confidence by the FDA in our cell therapy and a landmark achievement for Pluristem and its shareholders. It gives us the ability to begin treatments using our cell product, offering treatment to certain CLI patients who have poor therapeutic options, while also collecting real-world data alongside our ongoing Phase III clinical study… We are hopeful that the FDA may also allow us to be compensated for the costs of treatment, which can support our work developing effective cell therapies for millions of patients worldwide.”
How The Stock Is Reacting To The News
As investors, one of the first things that we learn is that the news moves the market. At the end of the day, any time a publicly-traded company releases positive news, we can expect to see gains in the value of the stock that’s representative of the company. With such positive news surrounding Pluristem Therapeutics, it only makes sense that we’re seeing strong gains in the value of the stock today. Currently (8:28), PSTI is trading at $1.67 per share after a gain of $0.20 per share (13.61%) 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 watching the ongoing development of PLX-PAD, and excited about the fact that the company will have real-world data to back up their clinical data from their Phase 3 clinical trial. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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