Cytokinetics AdComm Outcome Might Be Blessing In Disguise, This Analyst Said

  • Needham initiates coverage on Cytokinetics Inc CYTK with a Buy rating and a price target of $60.
  • Tuesday, FDA's Cardiovascular and Renal Drugs Advisory Committee voted 8-3 against the approval of Cytokinetics' omecamtiv mecarbil.
  • The analyst writes that these concerns were previously known but appear to be more severe than expected. 
  • Post-AdCom, the odds of omecamtiv FDA approval have fallen from 60-65% to below 50%. The analyst also expects that, if approved, omecamtiv is likely to carry labeling restrictions to restrict wide usage and minimize safety concerns.
  • Like other investors, Needham does not consider omecamtiv as a critical asset for the company, given that aficamten, which has the potential to address a much larger market opportunity, is in phase 3 trials and expected to report top-line in 2H23. 
  • Several investors may view the AdCom outcome and a potential non-approval of omecamtiv as a blessing in disguise, forcing Cytokinetics to focus its efforts and investments solely on aficamten.
  • Price Action: CYTK shares are up 12.10% at $40.35 on the last check Wednesday.
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