Filing for Full FDA Approval
Capricor is filing a BLA for full FDA approval for deramiocel to treat cardiomyopathy associated with DMD, with a potential PDUFA date in the second half of 2025.
Strong Financial Position
Capricor raised approximately $86 million in an oversubscribed public offering, resulting in a cash position of approximately $165 million, providing a runway into 2027.
Potential Expansion into European Market
Capricor entered into a term sheet with Nippon Shinyaku for the marketing, sales, and distribution of deramiocel in Europe, potentially leading to milestone payments totaling $1.5 billion.
Manufacturing Capabilities
Capricor has a fully operational manufacturing facility in San Diego and plans to expand manufacturing to meet anticipated demand.
Positive Feedback from Payers
Initial discussions with payers have been very positive, with reimbursement expected to be consistent with other DMD therapies.