- Myovant Sciences Ltd (NYSE: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 (NYSE: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.
