May 16, 2018 / 12:41 PM / 2 months ago

BRIEF-Evolus Announces Update With DWP-450 Regulatory Submissions

May 16 (Reuters) - Evolus Inc:

* EVOLUS ANNOUNCES PROGRESS WITH DWP-450 REGULATORY SUBMISSIONS

* EVOLUS INC - CONFERENCE CALL SCHEDULED FOR 8:30AM ET / 5:30AM PT

* EVOLUS INC - EVOLUS RECEIVES FDA COMPLETE RESPONSE LETTER WITH COMMENTS ISOLATED TO CMC ITEMS

* EVOLUS INC - PLANS TO UTILIZE DAEWOONG FACILITY TO SUPPORT COMMERCIAL PRODUCTION FOLLOWING ANTICIPATED APPROVAL OF DWP-450.

* EVOLUS INC - FDA ISSUES FAVORABLE EIR LETTER RELATED TO MANUFACTURING FACILITY

* EVOLUS INC - DWP-450 MANUFACTURING FACILITY IS FULLY VALIDATED BY DAEWOONG UNDER CURRENT GOOD MANUFACTURING PRACTICE REQUIREMENTS

* EVOLUS INC - IN CRL, DEFICIENCIES CITED BY FDA WERE ISOLATED TO ITEMS RELATED TO CHEMISTRY, MANUFACTURING, AND CONTROLS PROCESSES

* EVOLUS INC - EXPECTS TO RESPOND TO FDA ABOUT CRL WITH A COMPLETE SUBMISSION TO FDA WITHIN 90 DAYS

* EVOLUS INC - LOOK FORWARD TO WORKING CLOSELY WITH FDA AND REMAIN COMMITTED TO BRINGING DWP-450 TO MARKET BY SPRING 2019

* EVOLUS INC - DWP-450 MANUFACTURING FACILITY HAS CAPACITY EXPECTED TO MEET ANTICIPATED PRODUCT DEMAND Source text for Eikon: Further company coverage: (Reuters.Briefs@thomsonreuters.com)

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