Myovant's Relugolix Shows Promising Profile For Endometriosis Pain
The first Phase III trial testing relugolix combination therapy in endometriosis pain showed efficacy with minimal bone mineral density loss, an issue with AbbVie's rival drug Orilissa. An US NDA was also filed in prostate cancer.
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The miss on improving castration resistance-free survival in Phase III trial is not likely to affect the ongoing FDA review, the company and analysts agree.
Public Company Edition: The German mRNA-focused company could raise up to $245m based on its proposed price range, but investor interest could drive the offering’s total higher. Also, Perceptive launches another SPAC, Regeneron sells $2bn in debt and Biohaven secures up to $950m.
Keeping Track Of Submissions: Myovant’s First Relugolix NDA; Merck Resubmits Longer Keytruda Dosing; Biogen Adjusts Aducanumab Rolling Target
The latest news and highlights about submissions for US approval, from the Pink Sheet FDA Performance Tracker.