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Flexion Therapeutics Inc (FLXN.OQ)

FLXN.OQ on NASDAQ Stock Exchange Global Market

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Latest Key Developments (Source: Significant Developments)

Flexion Therapeutics Announces FDA Approval To Revise Zilretta Product Label
Friday, 27 Dec 2019 

Dec 26 (Reuters) - Flexion Therapeutics Inc ::FLEXION THERAPEUTICS ANNOUNCES FDA APPROVAL OF SNDA TO REVISE ZILRETTA® (TRIAMCINOLONE ACETONIDE EXTENDED-RELEASE INJECTABLE SUSPENSION) PRODUCT LABEL.FLEXION THERAPEUTICS - LABEL UPDATE INCLUDES REMOVAL OF LANGUAGE WHICH STATED THAT ZILRETTA WAS "NOT INTENDED FOR REPEAT ADMINISTRATION".FLEXION THERAPEUTICS - LABEL UPDATE INCLUDES INCLUSION OF STUDY DESCRIPTION, SAFETY DATA FROM SINGLE-ARM, OPEN-LABEL PHASE 3 REPEAT TRIAL.FLEXION THERAPEUTICS - LABEL UPDATE INCLUDES REMOVAL OF "MISLEADING STATEMENT" DESCRIBING SINGLE SECONDARY ENDPOINT IN ORIGINAL PHASE 3 TRIAL.FLEXION THERAPEUTICS - LABEL UPDATE INCLUDES INCLUSION OF NONCLINICAL TOXICOLOGY DATA FROM PREVIOUSLY SUBMITTED STUDIES IN NON-DISEASED ANIMALS.  Full Article

Flexion Therapeutics Announces Publication Of Independent Data Review Of Zilretta In The Journal Drugs
Tuesday, 2 Apr 2019 

April 2 (Reuters) - Flexion Therapeutics Inc ::FLEXION THERAPEUTICS ANNOUNCES PUBLICATION OF INDEPENDENT DATA REVIEW OF ZILRETTA® (TRIAMCINOLONE ACETONIDE EXTENDED-RELEASE INJECTABLE SUSPENSION) IN THE JOURNAL DRUGS.FLEXION THERAPEUTICS INC - EVALUATION CONCLUDED THAT ZILRETTA PROVIDED EFFECTIVE PAIN RELIEF, WAS GENERALLY WELL-TOLERATED.FLEXION THERAPEUTICS INC - COMPREHENSIVE REVIEW INCLUDED DATA FROM SIX CLINICAL STUDIES INVOLVING MORE THAN 1,300 PATIENTS.FLEXION THERAPEUTICS INC - EVIDENCE-BASED EVALUATION CONCLUDED THAT ZILRETTA PROVIDED EFFECTIVE PAIN RELIEF.FLEXION THERAPEUTICS INC - EVIDENCE-BASED EVALUATION CONCLUDED THAT ZILRETTA EXPANDS TREATMENT OPTIONS FOR OSTEOARTHRITIS (OA) KNEE PAIN.  Full Article

Flexion Therapeutics Enrolls First Patient In Phase 3 Trial Of Zilretta In OA Of The Hip
Thursday, 3 Jan 2019 

Jan 2 (Reuters) - Flexion Therapeutics Inc ::FLEXION THERAPEUTICS ENROLLS FIRST PATIENT IN PHASE 3 TRIAL OF ZILRETTA® (TRIAMCINOLONE ACETONIDE EXTENDED-RELEASE INJECTABLE SUSPENSION) IN OA OF THE HIP AND REPORTS RESULTS FROM SHIP STUDY.FLEXION THERAPEUTICS INC - PHASE 3 HIP OA REGISTRATION TRIAL EXPECTED TO COMPLETE IN 2020.FLEXION THERAPEUTICS - ADDITIONAL PHASE 2 STUDIES OF SHOULDER OA AND ADHESIVE CAPSULITIS (FROZEN SHOULDER) PLANNED FOR H2 2019.FLEXION-POSITIVE RESULTS FROM PHASE 2 PHARMACOKINETICS STUDY OF ZILRETTA IN OA OF SHOULDER, HIP SHOWED PROFILES CONSISTENT WITH OLDER STUDIES IN KNEE.FLEXION THERAPEUTICS INC - PHASE 2 RESULTS DEMONSTRATED THAT ZILRETTA WAS GENERALLY SAFE AND WELL TOLERATED.  Full Article