Regeneron Pharmaceuticals Inc. said Friday that it and its partner Sanofi received notice from the Food and Drug Administration that the biologics license application for sarilumab won't be approved until certain concerns are resolved. The FDA's "complete response letter" for sarilumab, a treatment for rheumatoid arthritis, refers to deficiencies indentified during a routine good-manufacturing-practice inspection of the Sanofi Le Trait facility in France where sarilumab is filled and finished. Regeneron said Sanofi submitted a corrective action plan to the FDA. Regeneron said it remains committed to the development of sarilumab. Regeneron's stock was down 2.5% prior to a trading halt, which is scheduled to be lifted at 3:05 p.m. ET. It has tumbled 34% year to date, while Sanofi shares have lost 9% and the S&P 500 has gained 4.1%.
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