FDA Accepts Gamida's Filing For Stem Cell Transplant Candidate Under Priority Review

The U.S. Food and Drug Administration (FDA) has accepted for filing the Gamida Cell’s GMDA Biologics License Application (BLA) for omidubicel in the treatment of patients with blood cancers in need of an allogenic hematopoietic stem cell transplant.

The regulatory agency has granted Priority Review for the BLA and has set a target action date of January 30, 2023.

The BLA submission is supported by the statistically significant results from the pivotal Phase 3 study, the results were published in Blood, the official journal of the American Society of Hematology.

Julian Adams, Chief executive officer, commented: The FDA's acceptance of our BLA with Priority Review signifies a critical milestone in our mission to deliver a new stem cell therapy option for patients in need of a donor for an allogeneic stem cell transplant. We look forward to working with the FDA throughout the review process to bring omidubicel to patients as quickly as possible."

The agency has indicated that it is not planning an advisory committee meeting as part of the BLA review.

The company underscored that if approved, omidubicel could become a treatment of choice for patients in need of an allo-HSCT transplant.

The FDA grants Priority Review that shortens review period of BLA, applicable for medicines which may offer significant improvements in the treatment, diagnosis, or prevention of a serious condition.

Price Action : Gamida shares are trading around 2 percent down at $1.64 on Monday at the time of publication.