Pluristem Therapeutics Inc. (NASDAQ: PSTI) is having an incredibly strong start to the trading session this morning, and for good reason. The comapny announced news from the FDA that opens the door for it to move forward with the continued development of its PLX-PAD. Of course, the news excited investors who are sending the stock on a run for the top. Today, we’ll talk about:
- The news;
- what we’re seeing from PSTI stock as a result; and
- what we’ll be watching for ahead.
PSTI Announces Regulatory News
As mentioned above, Pluristem Therapeutics is having an incredibly strong start to the trading session this morning after the company announced a regulatory update. In a press release issued early this morning, the company said it has entered into an agreement to initiate an FDA-cleared Expanded Access Program (EAP) for PLX-PAD, for the treatment of critical limb ischemia.
In the release, PSTI said that the FDA has authorized WideTrial to charge payment for the PLX-PAD EAP treatment. According to the EAP, an initial 100 Rutherford-5 CLI patients who are ineligible for inclusion under the company’s ongoing Phase 3 protocol and whose condition is life-threatening, will be enrolled. In a statement, Yaky Yanay, Co-CEO and President at PSTI, had the following to offer:
Patients suffering from critical limb ischemia are often unsuitable for revascularization and therefore experience poor clinical outcomes, including amputation. The condition can be fatal if left untreated… We believe the FDA’s decision to approve this Expanded Access Program with cost-recovery for this novel and potentially life-saving cell therapy reflects the Agency’s comfort with the safety profile of PLX-PAD, and recognition of its potential use in treating CLI patients who have few remaining treatment options. As we progress through the EAP, we look forward to generating valuable real world data concurrent with our ongoing 246-patient Phase 3 study that we are currently enrolling in U.S., Europe and Israel. Together, these clinical initiatives are expected to yield a significant body of evidence that we believe will support the safety and efficacy of PLX-PAD and may represent a significant advancement in the treatment of CLI.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to work in the market is that the news leads to moves. In the case of Pluristem, the news proved to be overwhelmingly positive. After all, the EAP will allow the company to produce data from patients that don’t fit into the design of the ongoing Phase 3 trial, offering more support for potential approval. Of course, this news excited investors, sending the stock on a run for the top. As is usually the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:38), PSTI is trading at $1.21 per share after a gain of $0.05 per share or 4.30% 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 continued development of the PLX-PAD treatment as it has yielded positive results in the past and the Phase 3 study as well as EAP are expected to yield similar data. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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