MiMedx Group Stock Tanks 60% After Late-Stage Trial For Plantar Fasciitis Treatment Fails

Shares of MiMedx Group Inc. (MDXG) plunged nearly 60% on Monday morning after the company’s late-stage trial for the treatment of plantar fasciitis failed to meet primary endpoint. The company said it will not pursue a Biologics License Application for this indication at this time.

MDXG is currently trading at $6.68, down $8.85 or 57.02%, on the Nasdaq, on a volume of 3.4 million shares, above average volume of 846 thousand shares. The stock has traded between $5.32 and $15.99 in the 52-week period.

According to a statement, the Phase 3 plantar fasciitis study did not meet its primary endpoints. The product and placebo groups both improved during the treatment period, and demonstrated reduced VAS Pain and improved Foot Function Index-Revised scores, without statistically significant separation between treatment groups.

The company also released op-line results from an interim analysis of the six-month efficacy data for the phase 2B trial for Knee Osteoarthritis, which also did not meet primary endpoints. However, the trial did reveal varied efficacy signals between patient cohorts evaluated pre- and post- a blinded interim analysis performed in mid-2019. As a result, the company plans for confirmatory efficacy studies for the Knee Osteoarthritis indication.

MiMedx Group plans to meet with the FDA to determine the appropriate path forward toward the initiation of phase 3 clinical trials in Knee Osteoarthritis. The company now believes that two phase 3 studies in Knee Osteoarthritis will be required to file a Biologics License Application.

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