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.

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

A pharmacist in a lab coat carefully analyzing a vial of medicine for its quality.

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.

While we acknowledge the potential of REGN to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than REGN and that has 100x upside potential, check out our report about this cheapest AI stock.

READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now.

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