Regeneron's EYLEA HD submissions delayed to Q4 2025.

• Regeneron Pharmaceuticals announces FDA extends target action dates for EYLEA HD submissions. • CMC Prior-Approval Supplement and sBLA submissions for EYLEA HD prefilled syringe and dosing schedule. • FDA extends review periods due to third-party manufacturer inspection information. • Target action dates shifted to fourth quarter 2025.

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) has announced that the U.S. Food and Drug Administration (FDA) has extended the target action dates for two EYLEA HD® (aflibercept) Injection 8 mg regulatory submissions. The FDA has pushed the review periods to the fourth quarter of 2025, citing significant amendments to the submissions following a recent inspection of the third-party manufacturer, Catalent Indiana LLC, which was acquired by Novo Nordisk A/S in December 2024 [1].

The extended review periods include a Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for the EYLEA HD prefilled syringe and a supplemental Biologics License Application (sBLA) seeking approval for both the treatment of macular edema following retinal vein occlusion (RVO) and the broadening of the dosing schedule to include every 4-week (monthly) dosing across approved indications. The FDA determined that the information provided since the completion of the inspection constituted a major amendment to each submission, necessitating the extension [1].

Regeneron had anticipated this delay, as discussed during their second quarter 2025 earnings announcement. The company submitted a comprehensive response in early August 2025 to address the observations noted by the FDA. Despite the delay, EYLEA HD remains available in the U.S. through vial administration, with current dosing intervals ranging from every 8 to 16 weeks for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), and every 8 to 12 weeks for patients with diabetic retinopathy (DR), following 3 initial monthly doses [1].

EYLEA HD, a vascular endothelial growth factor inhibitor, was developed to achieve comparable efficacy and safety to EYLEA, but with fewer injections. It is currently approved in the U.S. to treat patients with wAMD, DME, and DR. The drug is being jointly developed by Regeneron and Bayer AG, with Regeneron maintaining exclusive rights in the U.S. and Bayer holding exclusive marketing rights outside the U.S. [1].

The extended review periods may impact the commercialization timeline for EYLEA HD, particularly in its prefilled syringe form and for the treatment of RVO with monthly dosing. However, the FDA's ability to act expeditiously on these applications once the manufacturing issues are resolved suggests that the delay may be manageable. Investors should monitor the progress of these submissions and any potential regulatory decisions that may impact Regeneron's financial performance [1].

References:
[1] https://www.globenewswire.com/news-release/2025/08/20/3136582/0/en/EYLEA-HD-aflibercept-Injection-8-mg-Applications-for-Expanded-U-S-Label-and-Prefilled-Syringe-Receive-FDA-Review-Period-Extension.html