Gamida Cell Ltd (GMDAQ)

[midastouch017]

Gamida Cell Ltd. (GMDA)

https://www.nasdaq.com/articles/week-ahead-in-pharma%3A-data-readouts-at-worldsymposium-tct-meetings-gu-cancers-symposium

Gamida Cell is a cell therapy company focused on finding cures for blood cancers and serious hematologic diseases.

The company's lead product candidate Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers).

A phase III study evaluated the safety and efficacy of Omidubicel in patients with hematologic malignancies undergoing a bone marrow transplant compared to a comparator group of patients who received a standard umbilical cord blood transplant.

Last May, Gamida Cell reported that the study achieved its primary endpoint, demonstrating a highly statistically significant reduction in time to neutrophil engraftment, a key milestone in a patient's recovery from a bone marrow transplant.

Results reported last October showed that the Omidubicel phase III study achieved its secondary endpoints of platelet engraftment, infections, and hospitalizations.

A Biologics License Application for Omidubicel is expected to be submitted in the second half of this year.

On February 9, the company will be presenting the full efficacy and safety results of the phase III clinical trial of Omidubicel at the Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy (ASTCT) and Center for International Blood & Marrow Transplant Research (CIBMTR), which is being held virtually from February 8-12, 2021.

GMDA closed Friday's trading at $10.06, up 4.14%.