Regeneron Faces Setback With FDA Rejection Of Blood-Cancer Treatment

Regeneron Pharmaceuticals Inc. REGN has received a setback as the Food and Drug Administration has declined its application for a blood cancer treatment.

What Happened: The FDA rejected Regeneron’s application for linvoseltamab, a treatment for a form of blood cancer, the company announced on Tuesday. The FDA issued a complete response letter for the application, citing an issue related to a pre-approval inspection of a third-party fill/finish manufacturer.

“Linvoseltamab is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority,” Regeneron said in a statement.

The manufacturer, which is responsible for another company’s candidate, has informed Regeneron that it believes the issues have been resolved and is awaiting reinspection in the coming months.

Regeneron has pledged to collaborate closely with the third-party manufacturer and the FDA to ensure that linvoseltamab reaches patients, as most relapse and require additional treatments.

Linvoseltamab was granted a priority review by the FDA in February, a designation given to drugs with the potential to significantly improve the treatment of a serious disease.

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Why It Matters: Regeneron’s second-quarter earnings were robust, driven by strong sales of its key drugs. The company’s revenues increased by 12% year-over-year to $3.54 billion, with higher sales of Dupixent, Eylea HD, and Libtayo. The company also reported an adjusted EPS of $11.56, up 13% year over year, beating the consensus of $10.61.

Price Action: 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%, according to data from Benzinga Pro.

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This story was generated using Benzinga Neuro and edited by Kaustubh Bagalkote