Pluristem Therapeutics Inc. (NASDAQ: PSTI) is off to an incredibly strong start to the trading session this morning after the company announced that the FDA has granted Fast Track Designations to one of their pipeline drugs. As we have grown to expect, the news was overwhelmingly exciting to investors who are pushing the stock toward the top. Of course, our friends at Trade Ideas were the first to alert us to the gains. At the moment (9:30), PSTI is trading at $1.58 per share after a gain of $0.24 per share or 17.99% thus far today.
PSTI Gains On Fast Track Designation
As mentioned above, Pluristem Therapeutics is having an overwhelmingly strong start to the trading session today after the company announced some key FDA news. In a press release offered early this morning, the company announced that the United States Food and Drug Administration has granted Fast Track Designation surrounding PLX-PAD cells for the treatmnet of Critical Limb Ischema in patients that are ineligible for ravascularization.
As a result of the Fast Track Designation, PSTI will enjoy an expedited review process surrounding PLX-PAD. This will ultimately help the company bring the treatment to market at a faster rate should it qualify to be commercialized in the United States. In a statement, Zami Aberman, Chairman and Co-CEO at PSTI, had the following to offer:
“We are extremely pleased with the FDA’s decision to grant Fast Track Designation to PLX-PAD in the treatment of CLI. Up to 40% of patients with CLI are ineligible for revascularization and are at high risk of amputation and death within the first year of diagnosis. This disease takes a heavy toll on patients and their families, while the cost of treating CLI in the U.S. alone is estimated at over $25 billion per year. We are working tirelessly to provide a cell therapy that will address this severe unmet medical need.”
The above statement was followed up by Yaky Yanay, President and Co-CEO at PSTI, with the following:
“Regulators in some of the largest healthcare markets in the world are now in alignment regarding the need for accelerated approval pathways for our cell therapy product in the treatment of CLI. Programs like the Fast Track Designation offer real hope for patients battling this disease and we look forward to accelerating the path to market for PLX-PAD.”
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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 ongoing development surrounding PLX-PAD as well as other treatments in the company’s impressive pipeline. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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