Pluristem Wins Key FDA Approval

Shares of Pluristem Therapeutics Inc. (NASDAQ: PSTI) saw a handy gain early Monday after the company said it had received a key update from the U.S. Food and Drug Administration (FDA). Essentially the agency granted a Fast Track Designation to the firm’s ongoing late-stage study of PLX-PAD cells for the treatment of Critical Limb Ischemia (CLI) in patients ineligible for revascularization.

With this Fast Track Designation, Pluristem is gaining an increased possibility for a priority review by the FDA of PLX-PAD cells for the treatment of CLI.

The FDA’s Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and unmet medical needs.

Pluristem’s Phase 3 CLI study is ongoing and actively enrolling patients in the United States and Europe. The European Medicines Agency (EMA) has included PLX-PAD in its Adaptive Pathways program. Positive results from an interim analysis following treatment of half of the study’s population may lead to early conditional marketing authorization.

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Separately in Japan, the Pharmaceuticals and Medical Devices Agency (PDMA) has accepted PLX-PAD for the treatment of CLI into its accelerated regulatory pathway for regenerative therapies and has agreed on the design of a single study that may lead to early conditional marketing approval and reimbursement.

Zami Aberman, board chair and co-CEO of Pluristem, commented:

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.

Shares of Pluristem were last seen up about 12% at $1.34, with a consensus analyst price target of $2.75 and a 52-week range of $1.04 to $1.66. In premarket trading the stock was up as much as 21%.

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