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Monday, July 27, 2026

Capricor disputes FDA briefing materials for Deramiocel as based on outdated plan

 

Capricor disputes FDA briefing materials for Deramiocel as based on outdated statistical analysis plan

  • Company says FDA used an outdated statistical analysis plan in Deramiocel briefing materials for July 29 advisory committee.
  • Capricor posts portions of its July 29 advisory committee presentation slides on its website for investors.
  • Slides highlight statistically significant HOPE-3 results that Capricor says support Deramiocel’s efficacy.

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