Gamida Cell Shares Surge On Rolling Omidubicel Marketing Application In US

 Gamida Cell Ltd 

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 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.
• 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.

https://www.benzinga.com/general/biotech/22/02/25511786/gamida-cell-shares-surge-on-rolling-omidubicel-marketing-application-in-us