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BRIEF-Revance’s RT002 Meets Primary, Secondary Endpoints In Sakura Phase 3 Trials
December 5, 2017 / 12:46 PM / 10 days ago

BRIEF-Revance’s RT002 Meets Primary, Secondary Endpoints In Sakura Phase 3 Trials

Dec 5 (Reuters) - Revance Therapeutics Inc:

* REVANCE’S RT002 MEETS PRIMARY AND ALL SECONDARY ENDPOINTS, ACHIEVES 6-MONTH DURATION IN PIVOTAL SAKURA PHASE 3 TRIALS FOR GLABELLAR LINES

* SAYS RT002 DELIVERED HIGHLY STATISTICALLY SIGNIFICANT REDUCTION IN SEVERITY OF GLABELLAR LINES AT WEEK 24

* SAYS RT002 DELIVERED POSITIVE TOP-LINE RESULTS IN ALLEVIATING MODERATE-TO-SEVERE GLABELLAR LINES IN 2 PIVOTAL SAKURA PHASE 3 TRIALS

* SAYS RT002 APPEARED GENERALLY SAFE AND WELL-TOLERATED IN BOTH STUDIES

* SAYS ASSUMING SUCCESSFUL COMPLETION OF SAKURA 3, COMPANY PLANS TO SUBMIT A BIOLOGICS LICENSE APPLICATION IN FIRST HALF OF 2019

* SAYS LONG-TERM SAFETY TRIAL, SAKURA 3, IS FULLY ENROLLED AND IS EXPECTED TO BE COMPLETED IN SECOND HALF OF 2018

* SAYS COMPANY PLANS TO LAUNCH RT002 IN U.S. IN 2020, PENDING APPROVAL BY FDA Source text for Eikon: Further company coverage:

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