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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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