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Bayer (BAYRY - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the label extension of its ophthalmology drug, Eylea (aflibercept).
The CHMP recommended approval of the candidate for intravitreal injection 40 mg/mL in a prefilled syringe (PFS) for the treatment of preterm infants with retinopathy of prematurity (ROP). A decision from the European Commission on the label extension is expected in the coming months.
The recommendation is based on the phase III study FIREFLEYE and data from the follow-up study FIREFLEYE NEXT. Results from the FIREFLEYE study showed that treatment success with aflibercept 0.4 mg was high and achieved with mostly a single injection per eye in premature babies with severe retinopathy of prematurity.
Aflibercept’s 2 mg solution injection is approved under the brand name Eylea for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and the treatment of visual impairment due to macular edema following retinal vein occlusion (RVO; branch RVO or central RVO), diabetic macular edema (DME) and myopic choroidal neovascularization (myopic CNV).
Bayer will apply for a six-month patent term extension for the European patent covering aflibercept, the active ingredient in Eylea, once the European Commission decides on the label extension of Eylea. A potential extension would prolong the patent term until November 2025.
We note that Bayer has a collaboration agreement with Regeneron (REGN - Free Report) for the global development of aflibercept. While Regeneron owns exclusive rights to Eylea in the United States, Bayer has licensed exclusive marketing rights outside the United States, where the companies share equal profits from the sales of Eylea.
Eylea’s intravitreal injection 40 mg/mL has been approved for the treatment of preterm infants with ROP in Japan since September 2022.
Additional label extensions will further increase the growth potential of this leading ophthalmology drug.
Shares of Bayer have declined 1.7% in the year so far against the industry’s growth of 2.9%.
Image Source: Zacks Investment Research
Higher sales of the ophthalmology drug Eylea boosted Bayer’s Pharmaceuticals segment in the third quarter, along with the sales of the newly launched cancer drug Nubeqa.
Last month, Regeneron announced that the FDA granted pediatric exclusivity for Eylea injection, extending the period of U.S. market exclusivity for the drug by an additional six months through May 17, 2024.
The pediatric exclusivity determination was based on data from two phase 3 trials – BUTTERFLEYE and FIREFLEYE – which were submitted in response to the FDA's Written Request to evaluate the use of Eylea as a treatment for ROP in preterm infants.
Over the past 60 days, loss estimates for Syndax have narrowed to $2.59 from $2.68. Syndax also surpassed estimates in each of the trailing four quarters, with the average being 95.39%.
Over the past 60 days, loss estimates for Puma have narrowed to 6 cents from 16 cents. Puma also surpassed estimates in three of the trailing four quarters, with the average being 201.37%.
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Bayer (BAYRY) Eylea Label Extension Gets CHMP Positive Opinion
Bayer (BAYRY - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the label extension of its ophthalmology drug, Eylea (aflibercept).
The CHMP recommended approval of the candidate for intravitreal injection 40 mg/mL in a prefilled syringe (PFS) for the treatment of preterm infants with retinopathy of prematurity (ROP). A decision from the European Commission on the label extension is expected in the coming months.
The recommendation is based on the phase III study FIREFLEYE and data from the follow-up study FIREFLEYE NEXT. Results from the FIREFLEYE study showed that treatment success with aflibercept 0.4 mg was high and achieved with mostly a single injection per eye in premature babies with severe retinopathy of prematurity.
Aflibercept’s 2 mg solution injection is approved under the brand name Eylea for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and the treatment of visual impairment due to macular edema following retinal vein occlusion (RVO; branch RVO or central RVO), diabetic macular edema (DME) and myopic choroidal neovascularization (myopic CNV).
Bayer will apply for a six-month patent term extension for the European patent covering aflibercept, the active ingredient in Eylea, once the European Commission decides on the label extension of Eylea. A potential extension would prolong the patent term until November 2025.
We note that Bayer has a collaboration agreement with Regeneron (REGN - Free Report) for the global development of aflibercept. While Regeneron owns exclusive rights to Eylea in the United States, Bayer has licensed exclusive marketing rights outside the United States, where the companies share equal profits from the sales of Eylea.
Eylea’s intravitreal injection 40 mg/mL has been approved for the treatment of preterm infants with ROP in Japan since September 2022.
Additional label extensions will further increase the growth potential of this leading ophthalmology drug.
Shares of Bayer have declined 1.7% in the year so far against the industry’s growth of 2.9%.
Image Source: Zacks Investment Research
Higher sales of the ophthalmology drug Eylea boosted Bayer’s Pharmaceuticals segment in the third quarter, along with the sales of the newly launched cancer drug Nubeqa.
Last month, Regeneron announced that the FDA granted pediatric exclusivity for Eylea injection, extending the period of U.S. market exclusivity for the drug by an additional six months through May 17, 2024.
The pediatric exclusivity determination was based on data from two phase 3 trials – BUTTERFLEYE and FIREFLEYE – which were submitted in response to the FDA's Written Request to evaluate the use of Eylea as a treatment for ROP in preterm infants.
Bayer currently carries a Zacks Rank #2 (Buy). A couple of other top-ranked stocks in the biotech space include Syndax Pharmaceuticals (SNDX - Free Report) and Puma Biotechnology (PBYI - Free Report) . Both the stocks carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, loss estimates for Syndax have narrowed to $2.59 from $2.68. Syndax also surpassed estimates in each of the trailing four quarters, with the average being 95.39%.
Over the past 60 days, loss estimates for Puma have narrowed to 6 cents from 16 cents. Puma also surpassed estimates in three of the trailing four quarters, with the average being 201.37%.