February 14, 2018 / 9:13 PM / 2 months ago

BRIEF-Neurocrine Will File NDA For Opicapone For Parkinson's Disease Based On Existing Pivotal Clinical Trial Data

Feb 14 (Reuters) - Neurocrine Biosciences Inc:

* NEUROCRINE BIOSCIENCES WILL FILE NEW DRUG APPLICATION FOR OPICAPONE FOR PARKINSON’S DISEASE BASED ON EXISTING PIVOTAL CLINICAL TRIAL DATA

* NEUROCRINE BIOSCIENCES INC - NEUROCRINE WILL PROCEED WITH PLANS TO FILE NDA FOR OPICAPONE DURING FIRST HALF OF 2019

* NEUROCRINE BIOSCIENCES INC - U.S. FDA HAS PROVIDED GUIDANCE ON REGULATORY PATH FORWARD TO SUPPORT NDA FOR OPICAPONE

* NEUROCRINE BIOSCIENCES INC - NEUROLOGY DIVISION OF FDA HAS NOT REQUESTED CO TO CONDUCT AN ADDITIONAL PHASE III STUDY FOR OPICAPONE PRIOR TO NDA FILING Source text for Eikon: Further company coverage:

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