Regeneron faces setback from FDA rejection of blood cancer treatment – Regeneron Pharmaceuticals (NASDAQ:REGN)

Regeneron Pharmaceuticals Inc. RAIN has received a setback since Food and Drug Administration has rejected your request for blood cancer treatment.

What happened:The FDA has rejected Regeneron's application for linvoseltamab, a treatment for a form of blood cancer, the company said. announced On Tuesday, the FDA issued a complete response letter to the petition, citing an issue related to a pre-approval inspection of a third-party manufacturer of fill and finish products.

“Linvoseltamab is currently in 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 told Regeneron it believes the issues have been resolved and is awaiting further inspection in the coming months.

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

In February, the FDA granted linvoseltamab a priority review, a designation given to drugs with the potential to significantly improve the treatment of a serious disease.

See also: US to save $6 billion in first year, Biden administration says as it announces negotiated prices for 10 prescription drugs under Medicare

Why is it important?Regeneron's second-quarter earnings were solid, driven by strong sales of its key drugs. The company's revenue rose 12% year over year to $3.54 billion, with higher sales of Dupixent, Eylea HD and Libtayo. The company also reported adjusted EPS of $11.56, up 13% year over year, beating the consensus of $10.61.

Price action:Regeneron Pharmaceuticals shares closed at $1,192.23 on Tuesday, down 0.39% on the day. In after-hours trading, the stock was unchanged. Year-to-date, Regeneron stock has gained 31.74%, according to the report. Data from Benzinga Pro.

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