Regeneron provides update on biologics license application for odronextamab

Tarrytown, n.y., march 25, 2024 (globe newswire) -- regeneron pharmaceuticals, inc. (nasdaq: regn) today announced that the u.s. food and drug administration (fda) has issued complete response letters (crls) for the biologics license application (bla) for odronextamab in relapsed/refractory (r/r) follicular lymphoma (fl) and in r/r diffuse large b-cell lymphoma (dlbcl), each after two or more lines of systemic therapy. the only approvability issue is related to the enrollment status of the confirmatory trials. the crls – one for r/r fl and one for r/r dlbcl – did not identify any approvability issues with the odronextamab clinical efficacy or safety, trial design, labeling or manufacturing.
REGN Ratings Summary
REGN Quant Ranking