The company said that the FDA will now decide on its submissions by the fourth quarter of 2025.
Regeneron Pharmaceuticals, Inc. (REGN) announced on Wednesday that the U.S. Food and Drug Administration (FDA) has extended the date by which it is expected to rule on two of its EYLEA HD Injection regulatory submissions.
The company said that the FDA will now decide on its submissions by the fourth quarter of 2025. The agency extended review time after determining that information provided since the completion of a recent inspection of a third-party manufacturer constituted a major amendment to each submission. On Stocktwits, retail sentiment around REGN remained within the ‘bullish’ territory over the past 24 hours, while message volume increased from ‘low’ to ‘normal’ levels.
Regeneron had submitted applications pertaining to the EYLEA HD prefilled syringe and another 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 dosing across approved indications. The delay, however, was anticipated, the company said.
The firm said it resulted from observations during an FDA general site inspection at Catalent Indiana LLC, the filler for these regulatory applications.
Novo Nordisk recently acquired Catalent. The firm submitted a response earlier this month to address the observations noted by the FDA. Regeneron said that the FDA will be able to act on its applications once the manufacturing issues are resolved. The FDA was previously expected to decide on the submissions by August 2025.
EYLEA HD, however, remains available in the U.S. through vial administration and is approved to treat vision-threatening conditions that impact patients, such as wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retinopathy (DR).
REGN stock is down by 17% this year and by about 51% over the past 12 months.
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