Gamida Cell Ltd (GMDAQ)

[midastouch017]

Expected 2020-2021 Milestones

Gamida Cell targets achieving the following milestones during 2020-2021:

Omidubicel

Present data from the Phase 3 study at a medical meeting in the second half of 2020

Submit the biologics license application to the FDA in the second half of 2020, assuming positive data

Report additional data from the Phase 1/2 study in patients with severe aplastic anemia in the second half of 2020

Launch omidubicel in 2021, contingent upon FDA approval

GDA-201

Present additional data from the Phase 1 study in the first half of 2020

Submit company-sponsored investigational new drug application to FDA in the second half of 2020

Initiate a Phase 1/2 clinical study in patients with non-Hodgkin lymphoma in 2021

https://www.businesswire.com/news/home/20200113005222/en/Gamida-Cell-Announces-2020-Goals-Company-Update