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  • Yesterday Pluristem Therapeutics Inc PSTI announced top-line results from its Phase 3 trial evaluating PLX-PAD in 240 patients for muscle recovery following hip fracture surgery. 
  • HC wainwright believes the muscle strength results from the Phase 3 trial confirm the results seen in the Phase 1/2 trial, in which increases in gluteus medius strength and volume were observed at 26 weeks post-treatment.
  • The analyst reiterates a Buy rating with a price target of $10.
  • Related: Pluristem Posts Mixed Results From Study Of Muscle Regeneration After Hip Fracture Surgery.
  • “Given these data showing PLX-PAD’s ability to improve muscle strength, the panelist believes that these cells have potential in treating other indications, such as sports injuries, surgical injuries, and traumatic muscle-related injuries,” the analyst writes.
  • HC Wainwright says that given the ambiguities surrounding the efficacy of using SPPB to assess function following treatment with PLX-PAD, Pluristem plans to meet FDA to discuss an acceptable functional endpoint for the pivotal study. 
  • The company plans to meet with both FDA and EMEA to gain clarity regarding the regulatory pathway during 2022. Awaiting further details on the regulatory pathway for PLX-PAD, the analyst expects management to provide further details during 2H22. 
  • Price Action: PSTI shares are up 0.91% at $1.01 during the market session on the last check Friday.

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