Gamida Cell Shares Surge On Rolling Omidubicel Marketing Application In US

Gamida Cell Ltd 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.