Eylea HD (aflibercept) Injection 8 mg
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Cramer On Housing Stock: 'No One’s Buying Homes Here' - Netflix (NASDAQ:NFLX), FuboTV (NYSE:FUBO)
Benzinga· 2025-11-21 18:51
Group 1: FuboTV and Rocket Companies - FuboTV reported a 2.3% year-over-year decline in revenue for Q3 2025, totaling $377.20 million, which exceeded the analyst consensus estimate of $361.33 million [1] - Rocket Companies reported quarterly earnings of 7 cents per share, surpassing the Street estimate of 5 cents, with quarterly revenue of $1.78 billion, beating the consensus estimate of $1.66 billion [1] Group 2: Regeneron Pharmaceuticals - The U.S. FDA approved Regeneron Pharmaceuticals' Eylea HD Injection 8 mg for patients with macular edema following retinal vein occlusion, allowing for dosing every 8 weeks after an initial monthly period [2] - Regeneron Pharmaceuticals shares increased by 5% to close at $737.00 [5] Group 3: Stock Price Movements - Rocket Companies shares decreased by 3.6% to settle at $16.17 [5] - Netflix shares fell by 3.9% to close at $105.67 [5] - FuboTV shares dropped by 5% to close at $3.24 [5]
Regeneron Wins FDA Nod For Eylea HD With Reduced Injection Schedule For Patients With Vision Loss
Benzinga· 2025-11-20 16:52
Core Insights - The FDA approved Regeneron Pharmaceuticals' Eylea HD for treating macular edema following retinal vein occlusion, allowing for dosing every 8 weeks after an initial monthly period [1][4] - Eylea HD is the first treatment for retinal vein occlusion that can potentially reduce the number of injections by half compared to existing therapies, providing greater flexibility for physicians [3] - The approval was based on the Phase 3 QUASAR trial, which demonstrated non-inferior visual acuity gains for Eylea HD compared to the standard Eylea dosing [4] Product Details - Eylea HD (aflibercept) Injection 8 mg is specifically indicated for patients with retinal vein occlusion [1] - The FDA also approved a monthly dosing option for various conditions including wet age-related macular degeneration, diabetic macular edema, diabetic retinopathy, and retinal vein occlusion [2] - The results from the QUASAR trial were consistent across different types of retinal vein occlusions [5] Manufacturing and Market Impact - Regeneron is coordinating with Catalent Indiana to resolve issues identified during a July 2025 FDA inspection related to the Eylea HD pre-filled syringe [5] - The company plans to submit an application for an alternate manufacturing filler for Eylea HD by January 2026 [6] - Following the FDA approval, Regeneron’s stock price increased by 6.26%, reaching $746.72 [6]