What the FDA Has to Say About Regeneron’s Eylea

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Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) is facing some difficulty after it received an update from the U.S. Food and Drug Administration (FDA).

Essentially, the agency issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for Eylea (aflibercept) Injection in patients with wet age-related macular degeneration.

The sBLA was based on the second-year data from the VIEW studies, during which patients were treated with a modified 12-week dosing schedule (doses given at least every 12 weeks and additional doses as needed). Regeneron expects to complete these discussions and receive a final FDA action within roughly two months.

For some quick background: Eylea is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor, two growth factors involved in angiogenesis. In the United States, Eylea is the market-leading, FDA-approved anti-VEGF treatment for its approved indications and is supported by a robust body of research that includes seven pivotal Phase 3 trials.

Overall, Regeneron has underperformed the broad markets, with its stock down about 23% in the past 52 weeks. In just 2018 alone, the stock is down about 2.6%.

Shares of Regeneron were last seen trading at $363.82, with a consensus analyst price target of $406.05 and a 52-week range of $281.89 to $505.49.