Aug 13, 2026 earnings call — BLA review and pathway for Daramycin
AdCom voted 3 in favor 9 against; Capricor will submit a BLA amendment including 24 month open label extension data to seek a refined upper limb indication.
EPS $-0.70 (est $-0.59)
Key quotes
"FDA has indicated it is willing to review this amendment and upon receipt to extend the PDUFA action date accordingly."
"Our in house GMP manufacturing facility in San Diego is operational and positioned to support an initial commercial launch if approved."
"We continue to believe that the pricing structure in the US distribution agreement is fundamentally flawed, in a way that would impede patient access, and we continue to seek rescission."