Gamida Cell Ltd (NASDAQ:GMDA) has initiated the Biologics License Application (BLA) rolling submission process with the FDA for omidubicel, in patients with blood cancers needing stem cell transplant.
- The company remains on track to complete the BLA submission in Q2 of 2022.
- Omidubicel has the potential to be the first FDA-approved advanced cell therapy product for allogeneic stem cell transplant.
- Related: Cell Therapy-Focused Gamida Plans To Cut 10% Of Staff.
- In November, the FDA requested that Gamida Cell provide a revised analysis of the manufacturing data generated at Gamida Cell's commercial manufacturing facility to demonstrate the comparability to the omidubicel produced at the clinical manufacturing sites for Phase 3 study.
- The FDA did not request additional clinical data.
- The update pushed BLA submission to 1H of 2022 from the previous plan to submit the BLA by the end of 2021.
- Price Action: GMDA shares are up 18.4% at $3.52 during the market session on the last check Wednesday.
