Gamida Cell Ltd (GMDAQ)

[midastouch017]

Gamida Cell begins rolling submission with FDA for omidubicel for stem cell transplant

Feb. 09, 2022 8:36 AM ETGamida Cell Ltd. (GMDA)

By: Ravikash, SA News Editor

Gamida Cell (NASDAQ:GMDA) began a rolling submission of its biologics license application (BLA) with the U.S. Food and Drug Administration for omidubicel, a treatment for patients with blood cancers in need of stem cell transplant.The company said it remains on track to complete the BLA submission in Q2 2022.

"In the phase 3 study, omidubicel achieved a statistically significant reduction in time to neutrophil engraftment, reduced hospitalization time, decreased risk of infection and shorter time to platelet engraftment.
Based on this positive data, we believe omidubicel has the potential to address the existing unmet needs in allogeneic transplant, offering a new standard of care and the opportunity to treat even more patients," said Gamida CEO Julian Adams.

The company noted that omidubicel has the potential to be the first FDA approved advanced cell therapy product for allogeneic stem cell transplant.