Gamida Cell Ltd. (GMDA) Tops Q1 EPS by 6c

Gamida Cell Ltd. (NASDAQ: GMDA) reported Q1 EPS of ($0.34), $0.06 better than the analyst estimate of ($0.40).

“In the first quarter of this year, we made significant progress on key initiatives across all functions of our business, starting with omidubicel, a potentially transformative treatment option for patients with hematological malignancies,” said Julian Adams, Ph.D., chief executive officer of Gamida Cell. “We are working diligently to bring this novel therapy to patients, with submission of a BLA to the FDA anticipated in the fourth quarter of this year. We are progressing well with our manufacturing readiness activities in response to the clear feedback from the FDA regarding registration of our commercial manufacturing facilities and are actively building our launch readiness capabilities, including market access and support services, to ensure a positive patient experience at transplant at the time of potential FDA approval.”

“We also continue to expand our clinical pipeline with plans to submit an IND for our GDA-201 natural killer cell therapy, initiate a multi-center Phase 1/2 clinical study in NHL and continue to advance our R&D activities to pursue the development of genetically modified NAM-enabled NK cells in solid tumors. Importantly, we are well positioned to deliver our 2021 corporate goals and objectives toward improving the lives of the patients we serve,” Dr. Adams continued.

For earnings history and earnings-related data on Gamida Cell Ltd. (GMDA) click here.

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