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Tuesday, June 6, 2023

MiMedx Group Inc. (MDXG) Stock Plummets Following Failure of Clinical Trials to Meet Primary Endpoints

MiMedx Group Inc. (MDXG) stock prices plummeted by 59.75% some time after market trading commenced on September 13th, 2021. This brought the price per share down to USD$6.25.

MDXG Stock Announces Topline Data

September 13th, 2021 saw MDXG stock announce topline results from two late-stage muscoskeletal clinical trials. The trials were of the company’s micronized dehydrated Human Amnion Chorion Membrane. One was a Phase 2b clinical trial for the treatment of Knee Osteoarthritis, while the other was a Phase 3 clinical trial for the treatment of Plantar Fasciitis.

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Disappointing Results

Topline results from the interim analysis of the six-month efficacy data for the Phase 2b clinical trial for KOA failed to meet primary endpoints. Despite this, it did reveal varied efficacy signals between patient cohorts. This was a result of the evaluation before and after a blinded interim analysis performed in mid-2019. This prompted MDXG stock to plan for confirmatory efficacy studies for the KOA indication. The Phase 3 Plantar Fasciitis study also failed to meet its primary endpoints. The company does not have any current plans to pursue a BLA for this indication. The company’s mdHACM product was found safe and well-tolerated.

Recovering from Downtrend

After being examined and reviewed by the U.S FDA, these data will help the company decide its path forward. Additional clinical analyses are merited as MDXG stock pursues novel therapeutic solutions for patients with significant unmet needs. The company has proven itself to be a pioneer in amniotic tissue technology. This is evidenced by its investigational studies that serve to further the science and expand the scope of possibilities. Resultingly, the company finds itself able to consider next-gen treatments for these painful and debilitating conditions.

MDXG Stock’s Potential Scope

There is sizeable market demand for safe and effective alternative options to reduce pain, improve function, and modify disease. The potential positive signal within the KOA study facilitates opportunities to build on the data and pursue additional studies. The company is keen to continue collaborating with the FDA under the Regenerative Medicine Advanced Therapy (RMAT) process.

Future Outlook for MDXG Stock

The failure to meet primary endpoints for its flagship studies has been a severe blow to the company. MDXG stock is keen to allocated resources towards reversing the damage done as it works with the FDA. Current and potential investors are hopeful that management will be able to make the best of this bad situation. This is hoped to result in a recovery in shareholder value over the short and long term.

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