Regeneron acquired 23andMe for $256M, gaining 15M DNA profiles to enhance R&D. Find out why REGN stock is a Buy.

Alongside the financial details on its first-quarter performance, Regeneron also revealed that the FDA last week rejected the company’s application for a prefilled syringe version of Eylea HD.

Regeneron's first-quarter results missed Wall Street estimates on Tuesday due to stiff competition for its blockbuster drug Eylea, further stoking investor worries as U.S. regulators denied approval ...

Additionally, regulatory hurdles, such as the Complete Response Letter (CRL) received for the Eylea HD pre-filled syringe, have created obstacles for the company’s near-term growth plans. However, ...

REGN filed an application with the FDA for the use of the Eylea HD pre-filled syringe (PFS). A potential approval and launch are expected by mid 2025. Longer-term data in wet age-related macular ...

(An active ingredient is what makes a drug work.) It comes as a liquid solution in a vial or prefilled syringe. Your doctor will inject Eylea directly into your eye. For more details on Eylea ...

Moreover, in April 2025, Regeneron's US supplementary application for Eylea HD's prefilled syringe was rejected; this packaging format is important for the product's competitiveness with Vabysmo ...

Another complete response letter from the U.S. FDA for Regeneron Pharmaceuticals Inc.’s age-related macular degeneration (AMD) therapy Eylea (aflibercept) – along with disappointing sales of the VEGF ...

EYLEA HD is anticipated to gain traction with the launch of a prefilled syringe in mid-2025 and label expansions for macular edema and extended dosing intervals. Management believes these ...

Additionally, regulatory hurdles, such as the Complete Response Letter (CRL) received for the Eylea HD pre-filled syringe, have created obstacles for the company’s near-term growth plans.