Regeneron Updates on Linvoseltamab BLA Status
Regeneron Provides Update on Biologics License Application for Linvoseltamab
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for linvoseltamab in relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies. This anticipated outcome was disclosed during Regeneron’s second quarter 2024 earnings call.
The sole approvability issue identified is related to findings from a pre-approval inspection at a third-party fill/finish manufacturer for another company’s product candidate. The third-party fill/finish manufacturer has since informed Regeneron that it believes the findings have been resolved, their facility is awaiting reinspection by the FDA, and it is expected to take place in the coming months.
Regeneron is committed to working closely with the third-party fill/finish manufacturer and the FDA to bring linvoseltamab to appropriate patients with R/R MM as quickly as possible, which is critical because most MM patients relapse and ultimately require additional therapies in late-line settings.
Ongoing Regulatory Review
Regulatory review of linvoseltamab remains ongoing by the European Medicines Agency (EMA) in the same indication. Linvoseltamab is investigational, and its safety and efficacy have not been approved by any regulatory authority.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with various diseases including eye diseases, cancer, cardiovascular and metabolic diseases, and rare diseases.
Scientific Discoveries and Drug Development
Regeneron pushes the boundaries of scientific discovery and accelerates drug development using proprietary technologies, such as VelociSuite, which produces optimized fully human antibodies and bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center and pioneering genetic medicine platforms, enabling us to identify innovative targets to potentially treat or cure diseases.
Contact Information
Media Relations
Tammy Allen
Tel: +1 914-306-2698
Email: tammy.allen@regeneron.com
Investor Relations
Vesna Tosic
Tel: +1 914-847-5443
Email: vesna.tosic@regeneron.com
Frequently Asked Questions
What is the latest update on linvoseltamab's BLA?
Regeneron received a Complete Response Letter (CRL) from the FDA regarding the BLA for linvoseltamab.
What was the reason for the Complete Response Letter?
The CRL was issued due to findings from a pre-approval inspection at a third-party fill/finish manufacturer.
What steps is Regeneron taking next?
Regeneron is working closely with the third-party manufacturer and the FDA to resolve the issues and expedite the approval process.
Is linvoseltamab being reviewed by any other regulatory bodies?
Yes, the European Medicines Agency (EMA) is also reviewing linvoseltamab for the same indication.
What is Regeneron's mission?
Regeneron aims to invent, develop, and commercialize life-transforming medicines for people with serious diseases through innovative science and technologies.
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