Here's Why This Analyst Is On Sidelines Despite European Approval Of Myovant's Relugolix For Prostate Cancer

Myovant Sciences Ltd MYOV received European approval for Orgovyx (relugolix, 120 mg) for advanced hormone-sensitive prostate cancer, and SVB Securities think Orgovyx could be a ~$1 billion product in advanced prostate cancer long term.
But the surprise Myfembree setback in endometriosis has sparked uncertainty and new investor questions for Myovant's 2nd program.
Hence, SVB remains on the sidelines and awaits clarity on a possible complete response letter (CRL) by Myfembree's May 6 PDUFA date.
Due to low FDA detail on the reasons for the deficiency letter, investors are cautious and in a "wait and see mode" until more details are available.
While Myfembree's uterine fibroids launch has been gradual, SVB thought it could grab a solid niche despite a 2nd GnRH antagonist competitor - AbbVie Inc's ABBV Oriahnn/Orilissa (elagolix).
According to the analyst, a CRL and endometriosis approval delay could hinder Myfembree's differentiation vs. Oriahnn/Orilissa and possibly slow its physician uptake.
The analyst reiterates the Market Perform rating with the price target of $12.
Price Action: MYOV shares are up 4.83% at $9.76 during the market session on the last check Monday.