Editorial 2026-08-05 7 min read

The panel didn't vote on deramiocel. It voted on the SAP.

By Dr. Joseph L Smith

rweregulatorymethods

Key takeaway

The 9-3 advisory committee vote against Capricor's deramiocel turned on pre-specified analysis discipline rather than on the biology, and sponsors relying on a late analytical plan should read it as a warning about what a committee will credit.

One trial, two statistical analysis plans, two readings of the same patients.

References

Fierce Biotech — FDA adcomm shoots down Capricor's Duchenne cell therapy www.fiercebiotech.com/biotech/fda-adcomm-shoots-down-capricors-duchenne-cell-therapy-after-meeting-marked-statistical
BioSpace — FDA reviewers vote against approval of Capricor's DMD therapy www.biospace.com/fda/fda-reviewers-vote-against-approval-of-capricors-dmd-therapy-in-chaotic-adcomm-meeting
Synopulse OrphanPulse Wk 31 — The panel voted on a process, not a drug synopulse.com/orphanpulse-wk-31-the-panel-voted-on-a-process-not-a-drug/
Endpoints News — FDA adcomm shoots down Capricor cell therapy endpoints.news/fda-adcomm-shoots-down-capricor-cell-therapy/