TARRYTOWN, N.Y. - Regeneron (NASDAQ:REGN) Pharmaceuticals, Inc. (NASDAQ: REGN) announced today that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for their investigational drug linvoseltamab, intended for the treatment of adults with relapsed or refractory multiple myeloma. The disease, which is the second most common blood cancer in the United States, is known for its aggressive nature and resistance to cure, with an estimated 35,000 new cases annually.
Linvoseltamab, a bispecific antibody, is designed to connect B-cell maturation antigens on multiple myeloma cells with CD3-expressing T cells, aiming to enhance T-cell activation and subsequent destruction of cancer cells. The FDA has set a target action date of August 22, 2024, to make a decision on the therapy.
The application is backed by data from the Phase 1/2 LINKER-MM1 trial, which evaluated the safety and efficacy of linvoseltamab in patients who have undergone at least three prior therapies. The trial included an initial step-up dosing regimen followed by a full dose administration, with the option for patients who respond well to move from bi-weekly to monthly dosing after six months of treatment.
Regeneron's commitment to addressing hematologic conditions extends beyond linvoseltamab, with ongoing Phase 3 trials and additional studies in earlier lines of treatment and disease stages. The company is also planning a Phase 1 trial of linvoseltamab in combination with another bispecific antibody for multiple myeloma.
While the clinical development of linvoseltamab continues, the safety and efficacy of the drug have not yet been fully evaluated by any regulatory authority.
This press release statement serves as the basis for the information provided herein.
InvestingPro Insights
Amidst the anticipation of Regeneron Pharmaceuticals' (NASDAQ: REGN) linvoseltamab's FDA review, the company's financial health and market performance paint a robust picture. With a market capitalization of $101.75 billion and a trailing twelve-month P/E ratio of 23.47, Regeneron stands as a formidable entity in the biotechnology sector. The company's revenue growth over the last twelve months as of Q4 2023 was 7.76%, indicating a steady upward trajectory in financial performance.
InvestingPro Tips highlight Regeneron's aggressive share buyback strategy, which reflects management’s confidence in the company's value. Additionally, the stock's low price volatility suggests a stable investment, which could be appealing for investors looking for less risk in the biotechnology industry.
InvestingPro Data further reveals a strong return of 18.53% over the last three months, showcasing the stock's positive momentum. With a healthy gross profit margin of 52.32%, the company's ability to translate sales into profit remains impressive. These financial metrics, coupled with the upcoming decision on linvoseltamab, may influence investor sentiment and the company's future prospects.
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