Gamida Cell Ltd. (GMDA), a clinical-stage biopharmaceutical company, on Tuesday announced that it has received FDA clearance to initiate a phase I/II trial of a cryopreserved formulation of GDA-201 in patients with diffuse large B cell lymphoma and follicular lymphoma.
Last October, the FDA had placed the company's application for the cryopreserved formulation of GDA-201 on clinical hold, pending modifications to donor eligibility procedures and sterility assay qualification.
Now that the clinical hold has been lifted, the company plans to initiate a phase I/II study with cryopreserved formulation of GDA-201 in patients with follicular and diffuse large B-cell lymphomas this year.
An earlier investigator-sponsored study evaluating the fresh formulation of GDA-201 had demonstrated durable complete responses in heavily pre-treated patients with relapsed or refractory lymphoma.
GDA-201 is an off-the-shelf cell therapy candidate for the treatment of follicular and diffuse large B cell lymphomas. It leverages the company's proprietary NAM technology platform to expand the number and functionality of NK cells to direct tumor cell killing properties and antibody-dependent cellular cytotoxicity.
The unique properties of Nicotinamide is expected to expand and metabolically modulate multiple cell types - including stem cells and natural killer cells - with appropriate growth factors to maintain the cells' active phenotype and enhance potency.
Shares of Gamida Cell are currently trading in pre-market at $3.42, up $0.60 or 21.28 percent from the previous close.
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May 15, 2026 15:25 ET Apart from the confirmation of Kevin Warsh as the next Fed chair, the main news on the economics front this week included key price data from the U.S. and the first quarter economic growth figures from major economies. Both consumer prices and producer costs have started to reflect the effect of supply shocks due to the Middle East conflict. In Europe, GDP data was in focus, while inflation data from China dominated the news flow in Asia.