June 23, 2020 / 2:50 AM / 18 days ago

BRIEF-Sumitovant Biopharma Announces Priority Review, FDA Acceptance Of Myovant Sciences New Drug Application

June 22 (Reuters) - Sumitovant Biopharma:

* SUMITOVANT BIOPHARMA ANNOUNCES PRIORITY REVIEW AND FDA ACCEPTANCE OF MYOVANT SCIENCES NEW DRUG APPLICATION FOR ONCE-DAILY, ORAL RELUGOLIX FOR ADVANCED PROSTATE CANCER

* SUMITOVANT BIOPHARMA SAYS DATA FROM ADDITIONAL KEY SECONDARY ENDPOINT, CASTRATION RESISTANCE-FREE SURVIVAL, ARE EXPECTED IN Q3 OF 2020

* SUMITOVANT BIOPHARMA- FDA HAS SET A TARGET ACTION DATE OF DECEMBER 20, 2020 UNDER PRESCRIPTION DRUG USER FEE ACT

* SUMITOVANT BIOPHARMA - IN ACCEPTANCE LETTER, FDA STATED IT IS CURRENTLY NOT PLANNING TO HOLD ADVISORY COMMITTEE MEETING FOR APPLICATION Source text for Eikon:

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