Regeneron’s Lynozyfic Gains Accelerated FDA Approval for Multiple Myeloma

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) is one of the most undervalued large cap stocks to buy according to analysts. On July 2, the US FDA) granted accelerate approval to Regeneron Pharmaceuticals’s linvoseltamab-gcpt, which is marketed under the brand name Lynozyfic.

This bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager is approved for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least 4 prior lines of therapy, including a proteasome inhibitor, which is an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

A pharmacist in a lab coat carefully analyzing a vial of medicine for its quality.

The accelerated approval for Lynozyfic was based on positive results from the Phase 1/2 LINKER-MM1 trial. In the efficacy population of 80 patients who had received at least four prior lines of therapy, Lynozyfic demonstrated an objective response rate of 70% and a complete response rate of 45%. The FDA had previously issued a Complete Response Letter (CRL) for linvoseltamab due to findings from a pre-approval inspection at a third-party fill/finish manufacturer.

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) discovers, invents, develops, manufactures, and commercializes medicines for treating various diseases worldwide.

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Disclosure: None. This article is originally published at Insider Monkey.