TARRYTOWN, N.Y. - Regeneron (NASDAQ:REGN) Pharmaceuticals, Inc. (NASDAQ: REGN), a prominent biotechnology company with a market capitalization of $78 billion and strong financial health according to InvestingPro, has announced successful results from the Phase 3 QUASAR trial of EYLEA HD (aflibercept) Injection 8 mg for treating macular edema following retinal vein occlusion (RVO). The trial met its primary endpoint, demonstrating that EYLEA HD, administered every 8 weeks after initial monthly doses, was non-inferior in vision gains compared to the standard 4-week dosing regimen of EYLEA (aflibercept) Injection 2 mg. This development comes as Regeneron maintains robust financials, with revenue growing at 5.72% over the last twelve months and a healthy balance sheet showing more cash than debt.
Patients in the trial experienced improved vision with fewer injections, which could represent a significant advancement in the treatment of RVO. The study found that approximately 90% of patients treated with EYLEA HD maintained 8-week dosing intervals through 36 weeks.
The QUASAR trial was a global, double-masked, active-controlled study that compared the efficacy and safety of EYLEA HD to the existing EYLEA treatment. Both patient groups achieved non-inferior visual acuity gains at 36 weeks, with the EYLEA HD groups showing consistent results across different types of RVO, including central, branch, and hemiretinal vein occlusions.
Safety data from the trial indicated that the profile of EYLEA HD was similar to that of EYLEA, aligning with the safety profile known from pivotal trials. Ocular treatment emergent adverse events in EYLEA HD patients included increased ocular pressure and rare cases of endophthalmitis and retinal vasculitis.
Regeneron plans to submit a supplementary biologics license application for EYLEA HD to the U.S. Food and Drug Administration in the first quarter of 2025. The company, along with its collaborator Bayer AG (ETR:BAYGN), intends to present these findings at an upcoming medical meeting and submit the data to regulatory authorities worldwide.
EYLEA HD, which is being developed jointly by Regeneron and Bayer (OTC:BAYRY), is already approved for treating wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. Regeneron retains exclusive rights to EYLEA and EYLEA HD in the U.S., while Bayer holds exclusive marketing rights outside the U.S.
It is important to note that the safety and efficacy of EYLEA HD for the treatment of RVO have not yet been evaluated by any regulatory authority. The information in this article is based on a press release statement from Regeneron Pharmaceuticals. Currently trading near its 52-week low at $724.87, InvestingPro analysis suggests the stock may be undervalued, with additional insights available in the comprehensive Pro Research Report, which provides deep-dive analysis of this and 1,400+ other US stocks.
In other recent news, Regeneron Pharmaceuticals has been the subject of several analyst notes. RBC Capital Markets issued an "Outperform" rating for Regeneron, citing strong growth drivers such as new treatments and significant clinical readouts. The firm also highlighted Regeneron's solid financials, including a current ratio of 5.28 and more cash than debt on its balance sheet.
Piper Sandler reiterated its Overweight rating on Regeneron, maintaining confidence in the company's Eylea product line despite slow progress in transitioning to its High-Dose counterpart. Citi initiated coverage on Regeneron with a Neutral rating, noting concerns over potential market share erosion due to competition and the entry of biosimilars.
TD Cowen maintained a Buy rating on Regeneron shares, underscoring the potential of Eylea HD and Dupixent. The firm also emphasized the significant undervaluation of Regeneron's pipeline, suggesting a strong outlook for the company's research and development activities.
BMO Capital Markets adjusted its outlook on Regeneron shares, reducing the price target due to a shortfall in the high-dose version of Eylea and upcoming competition. However, Regeneron's management remains confident in their product's market position, expecting revenue growth in the second half of 2025. These are recent developments for Regeneron Pharmaceuticals.
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