07:58 AM EST, 02/11/2025 (MT Newswires) -- Regeneron Pharmaceuticals ( REGN ) said Tuesday that the US Food and Drug Administration has accepted for review the resubmission of the biologics license application for linvoseltamab as a potential the treatment for adult patients with relapsed or refractory multiple myeloma.

The indication is specifically for patients who have received at least four prior lines of therapy or who received three prior lines of therapy and are refractory to the last line of treatment, the company said.

The target action date for the FDA decision is July 10, the company said.

The resubmission follows the resolution of manufacturing issues which held up the previous submission, the company said.

An ongoing phase 2 trial of the drug is assessing linvoseltamab's safety and anti-tumor activity, the company said.