Latest news with #QUASAR
Yahoo
19-04-2025
- Business
- Yahoo
Regeneron announces FDA accepted Priority Review sBLA for EYLEA HD
On April 17, Regeneron (REGN) Pharmaceuticals announced that the U.S. Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application for EYLEA HD Injection 8 mg. The sBLA seeks approval for EYLEA HD for both the treatment of macular edema following retinal vein occlusion, RVO, and for broadening the dosing schedule to include every 4-week dosing across approved indications. The FDA target action date is August 19, 2025, following the use of a Priority Review voucher. The sBLA is supported by data from across the EYLEA HD clinical program, including the Phase 3 QUASAR trial investigating EYLEA HD in RVO. Discover outperforming stocks and invest smarter with Top Smart Score Stocks. Filter, analyze, and streamline your search for investment opportunities using Tipranks' Stock Screener. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See Insiders' Hot Stocks on TipRanks >> Read More on REGN: Disclaimer & DisclosureReport an Issue Regeneron, Sanofi announce FDA approval of Dupixent for CSU Regeneron announces FDA accepted Priority Review sBLA for EYELEA HD Regeneron price target lowered to $150 from $170 at Canaccord Regeneron price target lowered to $547 from $575 at BofA Regeneron Downgraded to Sell Amid Eylea Sales Decline and Market Pressures
Yahoo
11-02-2025
- Business
- Yahoo
Regeneron's macular oedema therapy shows promise in Phase III trial
Regeneron Pharmaceuticals has reported positive outcomes from the Phase III QUASAR trial of Eylea HD (aflibercept) 8mg injection in treating individuals with macular oedema following retinal vein occlusion (RVO). The trial met the primary endpoint of mean change in best corrected visual acuity (BCVA) from randomisation to week 36, as assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score. Subjects treated with the injection every eight weeks showed non-inferior visual acuity gains against those receiving the 2mg dosage of Eylea injection given every four weeks. According to the company, the findings are consistent across various types of RVO, including central, branch, and hemiretinal vein occlusions. Through the 36 weeks, an 88% of the Eylea HD-treated subjects were found to have sustained eight-week regimen after three initial monthly doses, and 93% after five initial monthly doses. The safety profile of Eylea HD was found to be comparable to that of Eylea and consistent with the established safety data from its pivotal trials. The trial outcomes are expected to support a supplemental biologics license application (sBLA) to be filed with the US Food and Drug Administration (FDA) in the first quarter of this year. Eylea HD is developed by Regeneron in partnership with Bayer. The QUASAR trial is being conducted by Bayer as part of its collaboration agreement with Regeneron. Regeneron holds exclusive rights for the asset in the US, while Bayer holds exclusive marketing rights outside of the US. The two companies share profits from sales equally in markets outside the US. In August 2021, Regeneron reported that an 8mg dose of aflibercept met the primary safety goal in a Phase II trial for wet age-related macular degeneration patients. "Regeneron's macular oedema therapy shows promise in Phase III trial" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
10-02-2025
- Business
- Yahoo
Regeneron's macular oedema therapy shows promise in Phase III trial
Regeneron Pharmaceuticals has reported positive outcomes from the Phase III QUASAR trial of Eylea HD (aflibercept) 8mg injection in treating individuals with macular oedema following retinal vein occlusion (RVO). The trial met the primary endpoint of mean change in best corrected visual acuity (BCVA) from randomisation to week 36, as assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score. Subjects treated with the injection every eight weeks showed non-inferior visual acuity gains against those receiving the 2mg dosage of Eylea injection given every four weeks. According to the company, the findings are consistent across various types of RVO, including central, branch, and hemiretinal vein occlusions. Through the 36 weeks, an 88% of the Eylea HD-treated subjects were found to have sustained eight-week regimen after three initial monthly doses, and 93% after five initial monthly doses. The safety profile of Eylea HD was found to be comparable to that of Eylea and consistent with the established safety data from its pivotal trials. The trial outcomes are expected to support a supplemental biologics license application (sBLA) to be filed with the US Food and Drug Administration (FDA) in the first quarter of this year. Eylea HD is developed by Regeneron in partnership with Bayer. The QUASAR trial is being conducted by Bayer as part of its collaboration agreement with Regeneron. Regeneron holds exclusive rights for the asset in the US, while Bayer holds exclusive marketing rights outside of the US. The two companies share profits from sales equally in markets outside the US. In August 2021, Regeneron reported that an 8mg dose of aflibercept met the primary safety goal in a Phase II trial for wet age-related macular degeneration patients. "Regeneron's macular oedema therapy shows promise in Phase III trial" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
