Gamida Cell Shares Surge On Rolling Omidubicel Marketing Application In US

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.