Myovant Sciences: EMA to Review Relugolix for Advanced Prostate Cancer
March 29 2021 - 9:38AM
Dow Jones News
By Colin Kellaher
Myovant Sciences Ltd. on Monday said the European Medicines
Agency validated its application seeking approval of relugolix for
the treatment of advanced prostate cancer.
The biopharmaceutical company said the validation confirms that
the filing is complete and begins the agency's centralized review
process for the application.
Myovant noted that under a collaboration agreement, Pfizer Inc.
has an exclusive option to commercialize relugolix in oncology
outside of the U.S. and Canada, excluding certain Asian countries,
with a decision expected in the first half of the year. If Pfizer
exercises the option, Myovant would receive a $50 million payment,
along with double-digit royalties on sales.
The U.S. Food and Drug Administration in December approved
relugolix, marketed as Orgovyx, for adults with advanced prostate
cancer.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
March 29, 2021 09:23 ET (13:23 GMT)
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