09:52 AM EDT, 03/25/2024 (MT Newswires) -- Regeneron Pharmaceuticals' ( REGN ) shares were down nearly 1 percent in early trading Monday after it received negative feedback from the Food and Drug Administration regarding its Biologics License Application for odronextamab, a potential treatment for relapsed or refractory forms of both follicular lymphoma and diffuse large B-cell lymphoma.

The company said the FDA issued Complete Response Letters for the indications, suggesting its applications for odronextamab would not be approved in their present form. The stumbling block, the company said, was related to the enrollment status of the confirmatory trials rather than clinical efficacy or safety, trial design, labeling, or manufacture of odronextamab

The European Medicines Agency is also considering approval of odronextamab as a potential treatment of both lymphomas, the company said.

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