Evicenter
P&T meetings

Deramiocel (CAP-1002)

Duchenne muscular dystrophy

Launch
Not announced
Last updated
92 sources

Product information and disease descriptionProduct description

Phase of product development

7 evidence topics · 10 sources

Regulatory status

“We currently have no products approved for commercial sale.” (opens the source at this quote in a new tab)

FDA submission

“The full submission of the rolling BLA was completed as the Company had previously guided in late December 2024” (opens the source at this quote in a new tab)

Complete response letter

“the BLA does not meet the statutory requirement for substantial evidence of effectiveness and the need for additional clinical data.” (opens the source at this quote in a new tab)

Regulatory submission: Class 2 BLA resubmission submitted February 2026

“the Company plans to submit the requested materials to the FDA in February 2026” (opens the source at this quote in a new tab)

“the recent submission of the HOPE-3 clinical study report to the FDA as part of our ongoing BLA review process” (opens the source at this quote in a new tab)

“The submission has been classified as a Class 2 resubmission” (opens the source at this quote in a new tab)

FDA Advisory Committee

“did not support the effectiveness of Deramiocel for the treatment of cardiomyopathy” (opens the source at this quote in a new tab)

“(3 for, 9 against, 0 abstain).” (opens the source at this quote in a new tab)

“The Committee's vote is non-binding.” (opens the source at this quote in a new tab)

Anticipated FDA action date

“New PDUFA target action date of November 22, 2026” (opens the source at this quote in a new tab)

Launch

No evidence found.

Special FDA designations

“Capricor Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Duchenne Muscular Dystrophy Therapy” (opens the source at this quote in a new tab)

“has granted Rare Pediatric Disease Designation to CAP-1002” (opens the source at this quote in a new tab)

“Orphan Drug Designation previously granted to CAP-1002 by the FDA” (opens the source at this quote in a new tab)