Pluristem Therapeutics Inc. (NASDAQ: PSTI) is having an incredibly strong start to the trading session this morning, and for good reason. The company provided a clinical update, exciting investors and sending the stock on a run for the top. Today, we’ll talk about:
- The clinical update;
- what we’re seeing from PSTI stock as a result; and
- what we’ll be watching for ahead.
PSTI Announces Clinical Update
As mentioned above, Pluristem Therapeutics is having an incredibly strong start to the trading session this morning after announcing a clinical update. The update came by way of press release early this morning.
In the release, PSTI announced that it has acheived a significant milestone in the ongoing development of its PLX-PAD. The treatment is currently being developed as a potential option to treat critical limb ischemia, also known as CLI.
According to the press release, the company has met its enrollment timelines relating to its Phase III pivotal study in CLI sooner than expected. At teh moemnt, more than 50% of the study’s patients have been enrolled.
This milestone allows for an interim analysis of efficacy after a one-year follow-up period under the EMA’s Adaptive Pathways pilot project; a project that PLX-PAD was selected for.
If the interim analysis proves to be positive, it could support an application for conditional marketing approval. In this case, the positive data would accelerate the approval and commercial availability of the product in Europe.
The Company also announced the official initiation of the FDA-approved Expanded Access Program in the United States. This includes several site initiations in the region. Ultimately, this will make the PLX-PAD cell therapy product available to patients that are not eligible for inclusion in the Phase III trial.
In a statement, Zami Aberman, Chairman and Co-CEO at PSTI, had the following to offer:
Pluristem’s development program for its novel cell therapy, PLX-PAD, for the treatment of CLI continues to progress, and we are rapidly approaching a significant data milestone with a potential interim efficacy analysis that could expedite commercial availability in Europe.
We are pleased to see positive collaboration from our clinical sites, where we beat our expected timelines for patient enrollment. We will use the remaining year to prepare the company for its potential application for conditional marketing approval in Europe under the adaptive pathway designation. We look forward to conducting this interim analysis with the goal of making this promising therapy available to patients as quickly as possible.
CLI is a devastating disease that can result in diminished quality of life and a high risk of amputation and death. With lack of suitable non-surgical therapeutic options for the growing population of CLI patients, new approaches such as cell therapy are warranted.
In multiple completed studies to date, PLX-PAD demonstrated significant improvement in reducing the risk for amputation and death, improved tissue perfusion and reduced ischemic pain, all while demonstrating a very favorable safety profile. We are glad to receive the FDA’s support for our EAP and are privileged to be able to provide PLX-PAD to patients in need, with the goal to prevent amputations and save lives.”
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dig into the market is that the news leads to moves. When it comes to Pluristem Therapeutics, the news proved to be overwhelmingly positive.
After all, the clinical update pushes the company one step closer to potential approval both in Europe and in the United States. Should the drug be approved, it will likely become a strong source of revenue for the company.
So, it’s not surprising to see that excited investors are pushing the stock on a run for the top in the market this morning. As is just about always the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:37), PSTI is trading at $0.60 per share after a gain of $0.027 per share or 4.71% 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 story surrounding the company’s continued work to bring its PLX-PAD product to market. Nonetheless, we’ll keep a close eye on the news and bring it to you as it breaks!
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