We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Regeneron Gets FDA Nod for Eylea Injection Prefilled Syringe
Read MoreHide Full Article
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the FDA has approved the Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for lead drug Eylea (aflibercept) Injection prefilled syringe.
The 2 mg, single-dose, sterilized prefilled syringe will provide physicians a new and a better way to administer Eylea that requires fewer preparation steps compared to vials.
The syringe will be available in the market later this year.
Eylea is the only anti-vascular endothelial growth factor (VEGF) approved to treat four retinal conditions with a single-dose strength prefilled syringe.
We remind investors that the drug is indicated to treat neovascular (wet) age-related macular degeneration (wet AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR).
Last week, Regeneron reported better-than-expected results for the second quarter of 2019, wherein both earnings and sales beat estimates on strong Eylea sales.
Eylea sales in the United States came in at $1.160 billion, up 16.9% year over year.
Regeneron co-developed Eylea with the HealthCare unit of Bayer AG (BAYRY - Free Report) . The company is solely responsible for the sales of this eye drug and entitled to profits in the United States. However, it shares profits and losses from the ex-U.S. Eylea sales equally with Bayer, except in Japan where it receives a royalty on net sales.
Meanwhile, sales of Dupixent has been strong as well since approval. Regeneron has a collaboration agreement with Sanofi (SNY - Free Report) for this drug. The drug is approved for treating adults with moderate-to-severe atopic dermatitis. Regeneron is also working to expand Dupixent’s label to reduce dependence on Eylea. In May 2019, the European Commission (EC) approved the drug for use in adults and adolescents aged 12 years or older as an add-on maintenance treatment for severe asthma. The EC also approved the drug for use in adolescents aged 12-17 years with moderate-to-severe atopic dermatitis, who are candidates for systemic therapy. In June 2019, the FDA approved the drug for use with other medicines to treat chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults, whose disease is not controlled. Meanwhile, a phase III trial on the drug to treat severe atopic dermatitis in children aged 6-11 years met its primary and secondary endpoints.
We are impressed by Regeneron’s efforts to develop its pipeline. Earlier, the company inked a collaboration agreement with Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) to discover, develop and commercialize new RNA interference (RNAi) therapeutics for diseases of the eye and the central nervous system.
The successful development and commercialization of other candidates bode well for Regeneron and reduce its dependence on Eylea.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +98%, +119% and +164% in as little as 1 month. The stocks in this report could perform even better.
Image: Bigstock
Regeneron Gets FDA Nod for Eylea Injection Prefilled Syringe
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the FDA has approved the Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for lead drug Eylea (aflibercept) Injection prefilled syringe.
The 2 mg, single-dose, sterilized prefilled syringe will provide physicians a new and a better way to administer Eylea that requires fewer preparation steps compared to vials.
The syringe will be available in the market later this year.
Eylea is the only anti-vascular endothelial growth factor (VEGF) approved to treat four retinal conditions with a single-dose strength prefilled syringe.
We remind investors that the drug is indicated to treat neovascular (wet) age-related macular degeneration (wet AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR).
Last week, Regeneron reported better-than-expected results for the second quarter of 2019, wherein both earnings and sales beat estimates on strong Eylea sales.
Eylea sales in the United States came in at $1.160 billion, up 16.9% year over year.
Regeneron co-developed Eylea with the HealthCare unit of Bayer AG (BAYRY - Free Report) . The company is solely responsible for the sales of this eye drug and entitled to profits in the United States. However, it shares profits and losses from the ex-U.S. Eylea sales equally with Bayer, except in Japan where it receives a royalty on net sales.
Meanwhile, sales of Dupixent has been strong as well since approval. Regeneron has a collaboration agreement with Sanofi (SNY - Free Report) for this drug. The drug is approved for treating adults with moderate-to-severe atopic dermatitis. Regeneron is also working to expand Dupixent’s label to reduce dependence on Eylea. In May 2019, the European Commission (EC) approved the drug for use in adults and adolescents aged 12 years or older as an add-on maintenance treatment for severe asthma. The EC also approved the drug for use in adolescents aged 12-17 years with moderate-to-severe atopic dermatitis, who are candidates for systemic therapy. In June 2019, the FDA approved the drug for use with other medicines to treat chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults, whose disease is not controlled. Meanwhile, a phase III trial on the drug to treat severe atopic dermatitis in children aged 6-11 years met its primary and secondary endpoints.
We are impressed by Regeneron’s efforts to develop its pipeline. Earlier, the company inked a collaboration agreement with Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) to discover, develop and commercialize new RNA interference (RNAi) therapeutics for diseases of the eye and the central nervous system.
The successful development and commercialization of other candidates bode well for Regeneron and reduce its dependence on Eylea.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +98%, +119% and +164% in as little as 1 month. The stocks in this report could perform even better.
See these 7 breakthrough stocks now>>