WASHINGTON (dpa-AFX) - Regeneron Pharmaceuticals, Inc. (REGN) disclosed on
Monday that the FDA has issued Complete Response Letters, rejecting the approval
of the Biologics License Application for Odronextamab in relapsed/refractory
follicular lymphoma and in R/R diffuse large B-cell lymphoma after two or more
lines of systemic therapy.

This decision was made due to an issue concerning the enrollment status of the
confirmatory trials.

Regeneron intends to share updates on enrollment and regulatory timelines later
this year.



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