Yesterday Pluristem Therapeutics Inc (NASDAQ: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.

HC Wainwright Reiterates On Pluristem After Encouraging Initial Data