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Regeneron's 12-Week Eylea Dose Gets CRL From FDA for Wet AMD
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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) suffered a setback when the FDA issued a complete response letter (CRL) to its supplemental Biologics License Application (sBLA) for Eylea injection due to ongoing labeling discussions.
Regeneron’s stock has lost 2.5% in the year so far compared with the industry’s 5.1% decline.
The sBLA sought to expand Eylea’s label to patients with wet age-related macular degeneration (wet AMD). The sBLA was based on the second-year data from the VIEW studies, during which patients were treated with a modified 12-week dosing schedule (doses given at least every 12 weeks and additional doses as needed). Regeneron expects to complete these discussions and receive a final FDA action date within approximately two months.
We note Eylea is currently approved in wet AMD for every four- or eight-week dosing intervals, after three initial monthly doses.
Regeneron has 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 is entitled to profits in the United States. However, it shares profits and losses equally with Bayer from ex-U.S. Eylea sales, except in Japan where the company receives a royalty on net sales.
Eylea is approved in the United States, EU, Japan and other countries for the treatment of wet AMD, diabetic macular edema (DME), macular edema following retinal vein occlusion, which includes macular edema following central retinal vein occlusion and macular edema following branch retinal vein occlusion. It is also approved in the EU, Japan and certain other countries outside the United States for the treatment of myopic choroidal neovascularization and in the United States for the treatment of diabetic retinopathy in patients with DME.
Regeneron recently submitted a sBLA for Eylea for the treatment of diabetic retinopathy.
Eylea is Regeneron’s flagship drug and a potential label expansion will boost sales.
On the other hand, the news will relieve competitor Swiss pharma giant Novartis AG (NVS - Free Report) , which is evaluating brolucizumab (RTH258) in neovascular age-related macular degeneration (nAMD). In April 2018, Novartis announced positive data from late-stage trials on the candidate. The data from the studies showed that patients identified for brolucizumab 12-week treatment interval in phase III HAWK and HARRIER trials had 87% and 83% probability of successfully continuing on a 12-week interval through week 48, respectively.
Regeneron’s second-quarter results were impressive as the company comfortably beat both earnings and sales estimates on the back of growth in Dupixent’s sales. Regeneron and partner Sanofi (SNY - Free Report) are also working to expand Dupixent’s label. Dupixent is being studied in asthma, adolescent and pediatric atopic dermatitis, nasal polyps, eosinophilic esophagitis (EoE) and grass immunotherapy, with additional studies planned in 2018. Regeneron and partner Sanofi reported that a phase III trial, evaluating Dupixent to treat moderate-to-severe atopic dermatitis in adolescents (12-17 years of age), met its primary and key secondary endpoints. A phase II study on Dupixent was initiated in grass immunotherapy in the second quarter.
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Regeneron's 12-Week Eylea Dose Gets CRL From FDA for Wet AMD
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) suffered a setback when the FDA issued a complete response letter (CRL) to its supplemental Biologics License Application (sBLA) for Eylea injection due to ongoing labeling discussions.
Regeneron’s stock has lost 2.5% in the year so far compared with the industry’s 5.1% decline.
The sBLA sought to expand Eylea’s label to patients with wet age-related macular degeneration (wet AMD). The sBLA was based on the second-year data from the VIEW studies, during which patients were treated with a modified 12-week dosing schedule (doses given at least every 12 weeks and additional doses as needed). Regeneron expects to complete these discussions and receive a final FDA action date within approximately two months.
We note Eylea is currently approved in wet AMD for every four- or eight-week dosing intervals, after three initial monthly doses.
Regeneron has 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 is entitled to profits in the United States. However, it shares profits and losses equally with Bayer from ex-U.S. Eylea sales, except in Japan where the company receives a royalty on net sales.
Eylea is approved in the United States, EU, Japan and other countries for the treatment of wet AMD, diabetic macular edema (DME), macular edema following retinal vein occlusion, which includes macular edema following central retinal vein occlusion and macular edema following branch retinal vein occlusion. It is also approved in the EU, Japan and certain other countries outside the United States for the treatment of myopic choroidal neovascularization and in the United States for the treatment of diabetic retinopathy in patients with DME.
Regeneron recently submitted a sBLA for Eylea for the treatment of diabetic retinopathy.
Eylea is Regeneron’s flagship drug and a potential label expansion will boost sales.
On the other hand, the news will relieve competitor Swiss pharma giant Novartis AG (NVS - Free Report) , which is evaluating brolucizumab (RTH258) in neovascular age-related macular degeneration (nAMD). In April 2018, Novartis announced positive data from late-stage trials on the candidate. The data from the studies showed that patients identified for brolucizumab 12-week treatment interval in phase III HAWK and HARRIER trials had 87% and 83% probability of successfully continuing on a 12-week interval through week 48, respectively.
Regeneron’s second-quarter results were impressive as the company comfortably beat both earnings and sales estimates on the back of growth in Dupixent’s sales. Regeneron and partner Sanofi (SNY - Free Report) are also working to expand Dupixent’s label. Dupixent is being studied in asthma, adolescent and pediatric atopic dermatitis, nasal polyps, eosinophilic esophagitis (EoE) and grass immunotherapy, with additional studies planned in 2018. Regeneron and partner Sanofi reported that a phase III trial, evaluating Dupixent to treat moderate-to-severe atopic dermatitis in adolescents (12-17 years of age), met its primary and key secondary endpoints. A phase II study on Dupixent was initiated in grass immunotherapy in the second quarter.
Zacks Rank
Regeneron currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
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