Regeneron Pharmaceuticals Inc. (REGN) has encountered a setback as the Food and Drug Administration (FDA) has rejected its application for linvoseltamab, a potential treatment for a form of blood cancer. The company announced the news on Tuesday.
The FDA issued a complete response letter, citing concerns stemming from a pre-approval inspection of a third-party manufacturer responsible for the final stages of production (fill/finish). This manufacturer, which also handles another company’s drug candidate, has assured Regeneron that they believe the issues have been resolved. They are awaiting a reinspection in the coming months.
Regeneron is committed to working closely with the manufacturer and the FDA to ensure that linvoseltamab reaches patients, especially since many blood cancer patients experience relapses and need additional treatments.
It’s important to note that linvoseltamab is still under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority. The FDA had granted linvoseltamab a priority review designation in February, recognizing its potential to significantly improve the treatment of a serious disease.
This setback comes despite Regeneron’s strong second-quarter earnings. Driven by robust sales of its key drugs, the company’s revenues increased 12% year-over-year to $3.54 billion. Sales of Dupixent, Eylea HD, and Libtayo contributed to this growth. The company also reported an adjusted EPS of $11.56, a 13% year-over-year increase, exceeding the consensus estimate of $10.61.
Regeneron Pharmaceuticals stock closed at $1,192.23 on Tuesday, down 0.39% for the day. In after-hours trading, the stock remained unchanged. Year to date, Regeneron’s stock has gained 31.74%.
While the FDA’s rejection is a temporary setback, Regeneron remains dedicated to bringing linvoseltamab to market. The company’s commitment to collaboration with the manufacturer and the FDA provides hope for patients awaiting new treatment options.
