Regeneron hit by odronextamab CRLs
US biotech Regeneron Pharmaceuticals (Nasdaq: REGN) was trading nearly 1% lower at lunchtime on Monday.
This followed the news that the US Food and Drug Administration (FDA) had 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.
Regeneron has said that 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.
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