The FDA Extends the Review Deadlines for Two Submissions by Regeneron Pharmaceuticals (REGN)

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) is one of the Most Undervalued US Stocks According to Wall Street Analysts. On August 20, Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) announced that the FDA has extended the review deadlines for two regulatory submissions of EYLEA HD Injection 8 mg to the fourth quarter of 2025.

The submissions made to the FDA include approval requests for a prefilled syringe and a label expansion to treat macular edema caused by retinal vein occlusion, including a monthly dosing option for approved uses. Management noted that the extended period is due to additional information provided after an FDA inspection of a third-party manufacturer. The FDA considers these updates a significant amendment, lengthening the review time.

However, the EYLEA HD remains available in vial form in the United States, with approved dosing intervals. The company expects the FDA to act quickly once manufacturing issues are resolved.

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) is a biotechnology company that develops and manufactures medicines for serious diseases.

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Disclosure: None. This article is originally published at Insider Monkey.