Gamida Cell Ltd (GMDAQ)

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Gamida Cell provides key program updates and 2022 outlook

Jan. 31, 2022 8:51 AM ETGamida Cell Ltd. (GMDA)

By: Mamta Mayani, SA News Editor1 Comment

Gamida Cell (NASDAQ:GMDA) announces key program and business updates.
Following the recent receipt of positive Type B meeting correspondence from the FDA, the company will initiate a rolling BLA submission for omidubicel for patients with blood cancers in need of a stem cell transplant, in Q1 2022 and plans to complete the full BLA submission in H1 2022.

In parallel with the planned BLA submission, GMDA will evaluate alternatives for the commercialization of omidubicel, including potential U.S. or global partnerships.

With the objective of extending cash runway into mid-2023, Gamida Cell is reducing operating expenses primarily by implementing a workforce reduction of ~10% and delaying other hiring and planned spending in 2022.

The company expects to initiate Phase 1/2 clinical study of GDA-201 in patients with follicular and diffuse large B-cell lymphomas in 2022.

Gamida Cell plans to report its Q4 and FY 2021 financial results on March 16, 2022.