GMDA - Gamida stock soars 32% as FDA lifts hold on GDA-201 to start trial for treating blood cancer

Gamida Cell (NASDAQ:GMDA) said the U.S. Food and Drug Administration (FDA) lifted a clinical hold for a cryopreserved formulation of GDA-201. The company added that the FDA cleared its investigational new drug (IND) application to start a trial of its NK cell therapy candidate GDA-201 to treat patients with follicular and diffuse large B-cell lymphomas. Gamida expects to begin the company-sponsored phase 1/2  study in 2022. The company said GDA-201 uses its proprietary NAM technology platform to expand the number and functionality of NK cells to direct tumor cell killing properties and antibody-dependent cellular cytotoxicity. “FDA clearance of our IND for the cryopreserved formulation of GDA-201 represents a significant milestone for the company and reflects our team’s expertise in the development of NAM-enabled cell therapies,” said Gamida  CEO Julian Adams. GMDA +31.56% to $3.71 premarket April 26

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Gamida stock soars 32% as FDA lifts hold on GDA-201, to start trial for treating blood cancer