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.

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.

While we acknowledge the potential of REGN as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you’re looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock.

READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now.

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