TARRYTOWN, N.Y. - The U.S. Food and Drug Administration (FDA) has begun Priority Review of Regeneron Pharmaceuticals’ supplemental Biologics License Application for EYLEA HD (aflibercept) Injection 8 mg. The biotechnology giant, with a market capitalization of $58.79 billion and annual revenue of $14.2 billion, continues to demonstrate strong financial health according to InvestingPro analysis. The review, announced on April 17, 2025, could lead to the first treatment for retinal vein occlusion (RVO) requiring injections only every eight weeks following an initial monthly dosing period.
EYLEA HD seeks to halve the number of injections compared to current anti-VEGF therapies for RVO, which are indicated for monthly dosing. The FDA target action date for a decision on EYLEA HD is August 19, 2025.
Support for the application includes data from the Phase 3 QUASAR trial, which met its primary endpoint at 36 weeks. Patients receiving EYLEA HD every eight weeks, after initial monthly doses, achieved visual acuity gains comparable to those receiving the standard EYLEA Injection dosed every four weeks.
The QUASAR trial also indicated that the safety profile of EYLEA HD was similar to that of the standard EYLEA treatment. Increased ocular pressure was the most notable treatment-emergent adverse event, occurring in 5% of EYLEA HD patients compared to 1.7% of those on the standard EYLEA regimen. Despite recent market volatility, Regeneron maintains robust fundamentals with a healthy current ratio of 4.73 and a competitive P/E ratio of 13.4x. InvestingPro’s Fair Value analysis suggests the stock may be currently undervalued.
EYLEA HD is currently approved in the U.S. for other conditions, including wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retinopathy (DR). The treatment is jointly developed by Regeneron and Bayer AG, with Regeneron holding exclusive rights in the U.S. and Bayer marketing it internationally.
RVO, a common cause of vision loss in adults, occurs when a blockage in a vein in the retina leads to blood accumulation and increased pressure. It can result in blurry vision or vision loss and potentially serious complications like macular edema.
The FDA’s acceptance of this sBLA for Priority Review marks a significant step in potentially offering patients with RVO a less burdensome treatment regimen. The information discussed is based on a press release statement from Regeneron Pharmaceuticals, Inc. With earnings expected in 13 days and analysts maintaining positive forecasts, investors can access comprehensive analysis and 10+ additional ProTips through InvestingPro’s detailed research reports, available for over 1,400 US stocks.
In other recent news, Regeneron Pharmaceuticals has reported several key developments impacting its financial and strategic outlook. Guggenheim Securities and Bernstein SocGen Group have both adjusted their price targets for Regeneron, citing anticipated challenges with its drug Eylea. Guggenheim lowered its target to $940, while Bernstein reduced it to $979, maintaining their respective Buy and Outperform ratings. Eylea’s sales for the first quarter of 2025 are expected to decrease, with Guggenheim projecting $1.18 billion, slightly below consensus estimates.
In legal matters, a U.S. appeals court upheld a decision denying a stay on biosimilar versions of Eylea, potentially affecting Regeneron’s market share. Meanwhile, the European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended Regeneron’s linvoseltamab for conditional marketing authorization to treat multiple myeloma. Additionally, the FDA is reviewing Regeneron’s resubmitted Biologics License Application for odronextamab, a treatment for follicular lymphoma, with a decision expected by July 2025. Despite these challenges, Regeneron’s pipeline, including treatments for chronic obstructive pulmonary disease and blood cancers, continues to show promise, as noted by analysts.
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