Regeneron Provides Update on Biologics License Application for Linvoseltamab Page 1

TARRYTOWN, N.Y., Aug. 20, 2024 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for linvoseltamab in relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies. This expected outcome was previously disclosed during Regeneron’s second quarter 2024 earnings call.

The only issue identified with the approval relates to findings from a pre-approval inspection at a third-party fill/finish manufacturer for a product candidate from another company. The third-party fill/finish manufacturer has since informed Regeneron that it believes the findings have been resolved, that its facility is awaiting re-inspection by the FDA and that this is expected to occur in the coming months.