Replies to post #398 on Gamida Cell Ltd (GMDAQ)

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Gamida stock rises 13% as FDA grants priority review to stem cell therapy omidubicel

Aug. 01, 2022 7:21 AM ETGamida Cell Ltd. (GMDA)

By: Ravikash, SA News Editor

The U.S. Food and Drug Administration (FDA) granted priority review to Gamida Cell's (NASDAQ:GMDA) application seeking approval of stem cell therapy omidubicel to treat patients with blood cancers in need of an allogenic hematopoietic stem cell transplant.

The FDA accepted the company's Biologics License Application (BLA) and is expected to make a decision by Jan. 30, 2023.
Under priority review, the FDA's goal is to take action within six months,
compared to 10 months under standard review.

Gamida said the FDA is not planning to hold an Advisory Committee
meeting as part of the BLA review.

The company noted that the BLA was backed by data from a phase 3 trial.

Upon FDA approval, omidubicel will be manufactured at the Gamida's manufacturing facility in Israel, the company added.