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Mimedx Stock Plunges After Disappointing Data From Musculoskeletal Trials

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  • MiMedx Group Inc (NASDAQ: MDXG) stock dropped after announcing top-line results from two musculoskeletal trials of micronized dehydrated Human Amnion Chorion Membrane (mdHACM).

  • Top-line results from an interim analysis of the six-month efficacy data for the Phase 2B trial for Knee Osteoarthritis (KOA) did not meet primary endpoints.

  • The trial did reveal varied efficacy signals between patient cohorts evaluated pre-and post- a blinded interim analysis performed in mid-2019, prompting the Company to plan for confirmatory efficacy studies for the KOA indication.

  • The Company now believes that two Phase 3 studies in KOA will be required to file a marketing application and update for the timing of the filing, previously tentatively planned for late-2024 or early-2025.

  • The Phase 3 trial for Plantar Fasciitis (PF) also failed to meet its primary endpoint, and the Company will not pursue a marketing application for this indication.

  • Related content: Benzinga's Full FDA Calendar.

  • Price Action: MDXG stock is down 52.4% at $7.40 during the premarket session on the last check Monday.

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