Key facts
- MEDIPOST secured FDA agreement for a single pivotal Phase 3 study for CARTISTEM® in the U.S.
- This agreement supports a confirmatory evidence Biologics License Application (BLA) filing strategy.
MEDIPOST, a commercial stage cell therapy biotechnology company, announced on June 3, 2026, that it has reached an agreement with the U.S. Food and Drug Administration (FDA). The agreement pertains to the development of CARTISTEM® for the U.S. market. Specifically, the FDA has consented to a single pivotal Phase 3 study for the drug. This regulatory milestone is expected to pave the way for a confirmatory evidence Biologics License Application (BLA) filing strategy in the United States.