11:44 AM EDT, 08/20/2025 (MT Newswires) -- Regeneron Pharmaceuticals ( REGN ) said Wednesday the US Food and Drug Administration has extended the target action dates of two Eylea HD injection regulatory submissions to Q4.

The FDA extended the review periods due to information from a recent inspection of a third-party manufacturer, which it determined was a major amendment to the submission, Regeneron said.

The company also said that the delay was expected after a general site inspection by the FDA at the filler for the regulatory applications, Novo Nordisk ( NVO ) -owned Catalent Indiana.

Novo Nordisk ( NVO ) submitted a response earlier in the month to address the FDA's observations and Regeneron said it expects the agency to act promptly on the applications once the manufacturing issues have been resolved.

Eylea HD, jointly developed by Regeneron and Bayer, is a treatment for certain serious chorioretinal vascular diseases.

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