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.
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Posted In: Analyst ColorBiotechNewsHealth CareReiterationSmall CapAnalyst RatingsMoversTrading IdeasGeneralBriefsEuropean Medicines Agency
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