Regeneron Pharmaceuticals Inc. (REGN) stock is trading lower on Monday, probably in reaction to positive data from Kodiak Sciences Inc. (KOD) from the Phase 3 DAYBREAK trial for wet age-related macular degeneration (wAMD).

The study demonstrated that Zenkuda and tabirafusp-ted provided non-inferior vision gains compared to Regeneron's Eylea (aflibercept) after one year.

Zenkuda showed a strong, immediate clinical effect during the initial treatment phase, comparable to or exceeding aflibercept.

FDA Regulatory Context And Eylea HD Approvals

In November 2025, the U.S. Food and Drug Administration (FDA) approved Eylea HD (aflibercept) Injection 8 mg for patients with macular edema following retinal vein occlusion (RVO) with up to every 8-week dosing after an initial monthly dosing period.

The FDA also approved a monthly dosing option for some patients who may benefit from resuming this dosing schedule across approved indications: wAMD, diabetic macular edema (DME), diabetic retinopathy (DR), and RVO.

Kodiak Focuses On Six-Month Dosing Benchmark

Investors should note that Kodiak Sciences is assessing a six-month dosing schedule.

Kodiak noted that the six-month dosing establishes a first-line benchmark in wAMD.

“Twenty years after Lucentis (ranibizumab) was approved for wet AMD, the holy grail remains the same: robust anatomic disease control and maximal visual gains, sustained with less frequent dosing,” said David Brown, Chief Medical Officer, Retina Consultants of America.

“The DAYBREAK results with Zenkuda are truly impressive. Under an AI-guided retreatment algorithm that closely mirrors the zero-fluid-tolerance approach we use in clinic, more than half of patients were maintained on 24-week dosing through year one,” Brown further commented.

Latest Financial Performance of Eylea

Net product sales of Eylea HD increased 52% to $596 million in the second quarter of 2026, primarily due to higher sales volumes driven by increased demand, partly offset by a lower net selling price.

Net product sales of Eylea fell 45% to $412 million, negatively impacted by lower sales volumes driven by decreased demand as a result of continued competitive pressures and the continued transition of patients to EYLEA HD, and a lower net selling price.

REGN Price Action: Regeneron Pharmaceuticals shares were down 3.45% to $760.83 at the time of publication on Monday, according to market data.