Pluristem Wins Key FDA Approval

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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.

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%.