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, ...

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.

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.

Biotech company Regeneron (NASDAQ:REGN) missed Wall Street’s revenue expectations in Q1 CY2025, with sales falling 3.7% year on year to $3.03 billion. Its non-GAAP profit of $8.22 per share was 3% ...

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

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 ...

Schleifer emphasized the company’s confidence in resolving the FDA issues with the EYLEA HD pre-filled syringe ahead of the potential August 2025 approval for new indications. Anticipated ...

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 ...

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 ...

The FDA issued a complete response letter for the EYLEA HD prefilled syringe, delaying its approval and impacting potential sales growth. Regeneron Pharmaceuticals Inc (NASDAQ:REGN) faces ...