04:14 AM EDT, 08/21/2024 (MT Newswires) -- Regeneron Pharmaceuticals ( REGN ) said late Tuesday the US Food and Drug Administration has issued a complete response letter for its biologics license application for linvoseltamab as a potential treatment for relapsed or refractory multiple myeloma.

The company said the only reason for the FDA's withholding of approval was findings from an inspection at a third-party manufacturer for another company's product candidate.

The third-party manufacturer "has since informed Regeneron that it believes the findings have been resolved, their facility is awaiting reinspection by the FDA, and it is expected to take place in the coming months," the company said.

The investigational drug is also undergoing review by the European Medicines Agency for the same indication.