Gamida Cell Ltd (fka GMDAQ)

[midastouch017]

Gamida Cell plans rolling BLA submission for omidubicel for blood cancers; shares up 18%

Jan. 19, 2022 11:07 AM ETGamida Cell Ltd. (GMDA)

By: Jonathan Block, SA News Editor

Following a positive Type B meeting with the FDA, Gamida Cell (GMDA +18.9%) plans rolling BLA submission for omidubicel for blood cancers in need of stem cell transplant.

Omidubicel has Breakthrough Therapy Designation and has the potential to be the first FDA-approved advanced cell therapy for allogeneic bone marrow transplant, according the Gamida Cell.

Gamida Cell says that the FDA and the company have come to agreement that analytical comparability has been established between the commercial manufacturing facility and the omidubicel that was manufactured for the Phase 3 study by another company.

Check out why Seeking Alpha contributor Bret Jensen has a neutral rating on Gamida Cell.