May 3, 2018 / 11:13 AM / 5 months ago

BRIEF-Alnylam Achieves Alignment With FDA On Accelerated Development Path For Lumasiran

May 3 (Reuters) - Alnylam Pharmaceuticals Inc:

* ALNYLAM ACHIEVES ALIGNMENT WITH FDA ON ACCELERATED DEVELOPMENT PATH FOR LUMASIRAN, AN INVESTIGATIONAL RNAI THERAPEUTIC FOR THE TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1)

* ALNYLAM PHARMACEUTICALS INC - FDA ENDORSES PRIMARY ENDPOINT OF REDUCTION OF URINARY OXALATE AT SIX MONTHS FOR PIVOTAL STUDY DESIGN

* ALNYLAM PHARMACEUTICALS INC - COMPANY INTENDS TO INITIATE LUMASIRAN PHASE 3 STUDY IN MID-2018, WITH TOPLINE RESULTS EXPECTED IN 2019

* ALNYLAM PHARMACEUTICALS INC - IF LUMASIRAN PHASE 3 STUDY POSITIVE, AN NDA SUBMISSION ANTICIPATED IN EARLY 2020

* ALNYLAM PHARMACEUTICALS INC - CO AND FDA HAVE ALIGNED ON A STUDY SIZE OF APPROXIMATELY 25 PATIENTS WITH PH1 Source text for Eikon: Further company coverage:

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