Regeneron’s Therapy For Blood Cancer Bags FDA Approval: REGN Stock Jumps

Regeneron Pharmaceuticals, Inc. (REGN) on Wednesday announced that the U.S. Food and Drug Administration has granted accelerated approval for its Lynozyfic to treat adult patients with relapsed or refractory (R/R) multiple myeloma.

The drug is now approved in the U.S. for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody.

Multiple myeloma is the second most common blood cancer. According to Regeneron, there are over 187,000 new cases of the cancer diagnosed globally every year, with more than 36,000 diagnosed and 12,000 deaths anticipated in the U.S. in 2025.

The disease is characterized by the proliferation of cancerous plasma cells that crowd out healthy blood cells in the bone marrow, infiltrate other tissues, and cause potentially life-threatening organ injury.

Shares of Regeneron jumped 2% on Wednesday afternoon.

While Lynozyfic was granted accelerated approval based on the LINKER-MM1 trial in which patients experienced a 70% objective response rate, continued approval may depend upon verification and description of clinical benefit in a confirmatory trial, the company said.

George D. Yancopoulos, Chief Scientific Officer of Regeneron, said that the company is advancing its program for Lynozyfic, exploring its use in earlier lines of treatment as monotherapy and in novel combinations.

On Stocktwits, retail sentiment around Regeneron is trending in the ‘bearish’ territory over the past 24 hours while message volume remained at ‘low’ levels.

REGN stock is down by 23% this year and by about 48% over the past 12 months.  

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