Mimedx Stock Plunges After Disappointing Data From Musculoskeletal Trials

  • MiMedx Group Inc 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.
Posted In: BiotechNewsShort IdeasHealth CareSmall CapFDAMoversTrading IdeasGeneralBriefsPhase 2 TrialPhase 3 Trial