Brief: Mimedx Reports Top-Line Data From Two Late-Stage Musculoskeletal Trials With Proprietary Amniotic Tissue Technology

MiMedx

13/09/2021 12:49

Sept 13 (Reuters) - MiMedx Group Inc  MDXG.O :
    * MIMEDX REPORTS TOP-LINE DATA FROM TWO LATE-STAGE
MUSCULOSKELETAL
TRIALS WITH PROPRIETARY AMNIOTIC TISSUE TECHNOLOGY
    * MIMEDX GROUP INC - PHASE 2B KNEE OSTEOARTHRITIS (KOA)
STUDY
TOP-LINE INTERIM RESULTS DEMONSTRATE VARIED EFFICACY SIGNALS
BETWEEN PATIENT COHORTS
    * MIMEDX GROUP INC - COMPANY TO PURSUE PHASE 3 KOA
CONFIRMATORY
STUDIES
    * MIMEDX GROUP INC - INITIAL REVIEW OF PHASE 3 PLANTAR
FASCIITIS
TRIAL DATA DOES NOT SUPPORT A BIOLOGICS LICENSE APPLICATION
(BLA) FILING AT THIS TIME
    * MIMEDX GROUP - TOP-LINE RESULTS FROM AN INTERIM ANALYSIS
OF
SIX-MONTH EFFICACY DATA FOR PHASE 2B CLINICAL TRIAL FOR KOA DID
NOT MEET PRIMARY ENDPOINTS
    * MIMEDX GROUP INC - PHASE 3 PF STUDY DID NOT MEET ITS
PRIMARY
ENDPOINT, AND COMPANY WILL NOT PURSUE A BLA FOR THIS INDICATION
AT THIS TIME
    * MIMEDX GROUP INC - THROUGHOUT BOTH STUDIES, MDHACM PRODUCT
WAS
FOUND SAFE AND WELL-TOLERATED
    * MIMEDX - PLANS TO MEET WITH FDA TO REVIEW FINDINGS AND
DETERMINE
APPROPRIATE PATH FORWARD TOWARD INITIATION OF PHASE 3 CLINICAL
TRIALS IN KOA

Source text for Eikon:  ID:nGNX6Rcb8z 
Further company coverage:  MDXG.O 

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