Pluristem Therapeutics, Inc. (PSTI - Free Report) announced that the FDA has granted Fast Track designation to a phase III study evaluating its critical limb ischemia (“CLI”) candidate, PLacental eXpanded (PLX)-PAD cells. The candidate is being evaluated in patients who are not eligible for revascularization.
The FDA grants fast track designation to help the development and a faster review of drugs, which treat serious and unmet medical conditions. With this designation, the drug is expected to be granted priority review once it files a New Drug Application (NDA).
Pluristem’s shares were up almost 8.2% including after-market movement on Monday as investors cheered the FDA’s decision. However, shares of the company are down 0.7% so far this year, underperforming the industry’s gain of 15.6%.
The phase III study is currently enrolling patients in the United States and Europe. The candidate has also been included in Adaptive Pathways program by the European Medicines Agency. Any positive results from interim analysis of the phase III study will help Pluristem to receive an early conditional marketing authorization for the candidate.
Meanwhile, Japan’s Pharmaceuticals and Medical Devices Agency has also included PLX-PAD cells into its accelerated regulatory pathway for regenerative therapies.
Critical limb ischemia is a severe form of peripheral arterial disease where blood flow is reduced in the arteries in the legs due to deposition of fatty acids. Revascularization, a method of restoration of perfusion of blood to the blocked parts in ischemia patients, is generally achieved by surgery. Patients with CLI remain at the risk of limb amputation and death, which may be prevented by revascularization.
Per the press release, the number of CLI patients is expected to be around 5 to 6 million in the United States and Europe. The company estimates that 40% of CLI patients are ineligible for revascularization and the CLI market is estimated to be $25 billion per year.
The company is evaluating PLX cells in multiple indications, which includes inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage. The candidate has shown promising results in earlier studies.
Zacks Rank & Stocks to Consider
Pluristem has a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include PDL BioPharma, Inc. (PDLI - Free Report) , Alexion Pharmaceuticals, Inc. (ALXN - Free Report) and Regeneron Pharmaceuticals, Inc. (REGN - Free Report) . While Alexion and Regeneron carry a Zacks Rank #1 (Strong Buy), PDL BioPharma carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
PDL BioPharma’s earnings per share estimates increased 263% to 69 cents for 2017 and 174% to 63 cents for 2018 over the last 60 days. The company has topped estimates in two of the trailing four quarters with an average of 33.79%. Shares are up 56.6% so far this year.
Alexion Pharmaceuticals’ earnings per share estimates have moved up 5.3% to $5.60 for 2017 and 7.5% to $7.05 for 2018 over the last 60 days. The company delivered positive earnings surprises in the trailing four quarters, with an average beat of 11.12%. Share price of the company has increased 17.4% year to date.
Regeneron’s earnings per share estimates have increased 16.7% to $14.99 for 2017 and 8.6% to $16.64 for 2018 over the last 60 days. The company pulled off positive earnings surprises in two of the trailing four quarters, with an average beat of 10.11%. Share price of the company has increased 18.4% year to date.
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