Regeneron's BLA for Linvoseltamab Receives Complete Response Letter

FDA Requests Additional Data Before Approval

Phase 1/2 LINKER-MM1 Trial Findings to be Submitted to Regulatory Authorities

Tarrytown, NY - January 23, 2023 - Regeneron Pharmaceuticals Inc. (REGN) announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to the biologics license application (BLA) seeking approval of linvoseltamab for the treatment of relapsed/refractory multiple myeloma.

The FDA's CRL requests additional data before it can approve linvoseltamab. Regeneron states that it plans to submit the requested data to regulatory authorities and is on track to submit the BLA to the FDA later this year.

Linvoseltamab is a monoclonal antibody that targets BCMA, a protein expressed on multiple myeloma cells. The phase 1/2 LINKER-MM1 trial evaluated the efficacy and safety of linvoseltamab in patients with relapsed/refractory multiple myeloma. The trial results showed that linvoseltamab had promising antitumor activity and a manageable safety profile.

The FDA's CRL is a setback for Regeneron, but it is not uncommon for the agency to request additional data before approving a new drug. Regeneron remains committed to developing linvoseltamab and believes that it has the potential to be a valuable new treatment option for patients with multiple myeloma.

The company will host a virtual investor event on February 8, 2023, at 8:30 AM ET to discuss the CRL and its plans for linvoseltamab.