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FDA Extends Review Period of REGN's Submission for Eylea HD
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Key Takeaways
The FDA extended action dates to Q4 2025 for two Eylea HD regulatory submissions.
Extensions followed FDA findings at Catalent Indiana, a Novo Nordisk unit.
Eylea HD U.S. sales rose 29% in Q2, even as Eylea continues to decline.
Regeneron Pharmaceuticals, Inc. ((REGN - Free Report) ) announced that the FDA has extended the target action dates for Eylea HD (aflibercept) injection 8 mg regulatory submissions.
Eylea HD is the higher dose of Eylea.
The regulatory body has now extended the target action dates to the fourth quarter of 2025 for two regulatory submissions for Eylea HD (aflibercept) Injection 8 mg.
The submission includes a Chemistry, Manufacturing and Controls Prior-Approval Supplement for the Eylea HD prefilled syringe and a supplemental biologics license application 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.
Despite the extension announcement, REGN shares were up 3.4%. This information was previously communicated by the company during its second-quarter earnings release. This is probably because Eylea HD remains available in the United States through vial administration.
Regeneron’s shares have lost 17% year to date against the industry’s gain of 3.8%.
Image Source: Zacks Investment Research
More on REGN’s Eylea HD
The FDA extended the review periods after determining that the information submitted following a recent inspection of a third-party manufacturer constituted a major amendment to each application. The anticipated delay resulted from observations during an FDA general site inspection of Catalent Indiana LLC, which Novo Nordisk A/S ((NVO - Free Report) ) acquired in December 2024.
Novo Nordisk submitted a comprehensive response in early August 2025 to address the observations noted by the FDA.
Eylea HD is approved with dosing intervals every 8 to 16 weeks for patients with wet age-related macular degeneration and diabetic macular edema, and every 8 to 12 weeks for patients with diabetic retinopathy, following three initial monthly doses.
Eylea HD (known as Eylea 8 mg in the European Union and Japan) is being jointly developed by Regeneron and Bayer AG ((BAYRY - Free Report) ). While Regeneron holds exclusive rights to Eylea and Eylea HD in the United States, BAYRY holds the exclusive marketing rights outside the country.
REGN and BAYRY equally share the profits from sales of Eylea and Eylea HD.
REGN Banks on Eylea HD and Dupixent for Growth
Regeneron's performance in the second quarter was encouraging. The company has finally managed to post revenue growth despite declining sales of lead drug Eylea.
Eylea sales continue to decline due to competition from Vabysmo.
To counter the decline in Eylea sales, Regeneron has developed a higher dose of the drug. Eylea HD sales in the United States surged 29% in the second quarter due to higher sales volumes driven by increased demand.
REGN’s top line also comprises its share of profits/losses in connection with the global sales of Dupixent. Partner Sanofi (SNY) records global net product sales of Dupixent.
SNY and REGN are working to expand the drug’s label further. The FDA had earlier approved Dupixent for chronic obstructive pulmonary disease (COPD). The approved indication is an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype.
Consistent label expansions of Dupixent continue to fuel its sales and help REGN earn higher profits.
REGN is looking to strengthen its oncology portfolio to diversify its revenue stream.
The recent progress with its oncology pipeline has been encouraging. The approval of Lynozyfic is a boost for its oncology portfolio.
Image: Bigstock
FDA Extends Review Period of REGN's Submission for Eylea HD
Key Takeaways
Regeneron Pharmaceuticals, Inc. ((REGN - Free Report) ) announced that the FDA has extended the target action dates for Eylea HD (aflibercept) injection 8 mg regulatory submissions.
Eylea HD is the higher dose of Eylea.
The regulatory body has now extended the target action dates to the fourth quarter of 2025 for two regulatory submissions for Eylea HD (aflibercept) Injection 8 mg.
The submission includes a Chemistry, Manufacturing and Controls Prior-Approval Supplement for the Eylea HD prefilled syringe and a supplemental biologics license application 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.
Despite the extension announcement, REGN shares were up 3.4%. This information was previously communicated by the company during its second-quarter earnings release. This is probably because Eylea HD remains available in the United States through vial administration.
Regeneron’s shares have lost 17% year to date against the industry’s gain of 3.8%.
Image Source: Zacks Investment Research
More on REGN’s Eylea HD
The FDA extended the review periods after determining that the information submitted following a recent inspection of a third-party manufacturer constituted a major amendment to each application. The anticipated delay resulted from observations during an FDA general site inspection of Catalent Indiana LLC, which Novo Nordisk A/S ((NVO - Free Report) ) acquired in December 2024.
Novo Nordisk submitted a comprehensive response in early August 2025 to address the observations noted by the FDA.
Eylea HD is approved with dosing intervals every 8 to 16 weeks for patients with wet age-related macular degeneration and diabetic macular edema, and every 8 to 12 weeks for patients with diabetic retinopathy, following three initial monthly doses.
Eylea HD (known as Eylea 8 mg in the European Union and Japan) is being jointly developed by Regeneron and Bayer AG ((BAYRY - Free Report) ). While Regeneron holds exclusive rights to Eylea and Eylea HD in the United States, BAYRY holds the exclusive marketing rights outside the country.
REGN and BAYRY equally share the profits from sales of Eylea and Eylea HD.
REGN Banks on Eylea HD and Dupixent for Growth
Regeneron's performance in the second quarter was encouraging. The company has finally managed to post revenue growth despite declining sales of lead drug Eylea.
Eylea sales continue to decline due to competition from Vabysmo.
To counter the decline in Eylea sales, Regeneron has developed a higher dose of the drug. Eylea HD sales in the United States surged 29% in the second quarter due to higher sales volumes driven by increased demand.
REGN’s top line also comprises its share of profits/losses in connection with the global sales of Dupixent. Partner Sanofi (SNY) records global net product sales of Dupixent.
SNY and REGN are working to expand the drug’s label further. The FDA had earlier approved Dupixent for chronic obstructive pulmonary disease (COPD). The approved indication is an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype.
Consistent label expansions of Dupixent continue to fuel its sales and help REGN earn higher profits.
REGN is looking to strengthen its oncology portfolio to diversify its revenue stream.
The recent progress with its oncology pipeline has been encouraging. The approval of Lynozyfic is a boost for its oncology portfolio.
Zacks Rank
Regeneron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.