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Ra Pharmaceuticals Announces Completion of End-of-Phase 2 Interactions with FDA and Design of Pivotal Phase 3 gMG Study

April 9, 2019 7:00 AM EDT

Alignment with FDA on a single, pivotal, 12-week, placebo-controlled, Phase 3 clinical trial to initiate in the second half of 2019

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Ra Pharmaceuticals, Inc. (Nasdaq: RARX) today announced the successful completion of End-of-Phase 2 interactions with the U.S. Food and Drug Administration (FDA) for its Phase 3 clinical trial of zilucoplan for the treatment of generalized myasthenia gravis (gMG).

Based on feedback provided by the FDA, Ra Pharma plans to initiate a single, pivotal, Phase 3, randomized, double-blind, placebo-controlled trial evaluating the efficacy of a once-daily, subcutaneously (SC)... More