Shares of Regeneron Pharmaceuticals Inc. (REGN - Free Report) have gained 3.2% in the year so far against a decline of 5.9% for the industry.
Tarrytown, NY-based Regeneron's key areas of focus include eye diseases, heart diseases, allergic and inflammatory diseases, pain, cancer, infectious diseases, and rare diseases.
Regeneron’s key growth driver, Eylea continues to drive revenues for the company. Regeneron has co-developed Eylea with the HealthCare unit of Bayer AG (BAYRY - Free Report) . 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.
The FDA recently approved a supplemental Biologics License Application (sBLA) for Eylea injection in patients with wet AMD. The sBLA was based on second-year data from the phase III VIEW 1 and 2 trials, in which patients with wet AMD were treated with a modified 12-week dosing schedule (doses given at least every 12 weeks, and additional doses as needed).
Regeneron recently submitted an sBLA for the drug for the treatment of diabetic retinopathy. Eylea is Regeneron’s flagship drug and a potential label expansion will boost sales.
Label expansion of other approved drugs will also boost sales for the company.
Strong Dupixent sales drove Regeneron’s impressive second-quarter results. The company and partner Sanofi (SNY - Free Report) are also working to expand Dupixent’s label, which should diversify the company’s revenue base and reduce dependence on the lead drug. Dupixent is being studied in asthma, adolescent and pediatric atopic dermatitis, nasal polyps, eosinophilic esophagitis (EoE) and grass immunotherapy. Further, additional studies on the drug have been planned in 2018.
Regeneron is working to expand its portfolio/pipeline. The company and partner Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) also announced positive top-line results from a phase III study on pipeline candidate, fasinumab in patients suffering from chronic pain from osteoarthritis (OA) of the knee or hip.
Meanwhile, the FDA accepted for priority review of the Biologics License Application (BLA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not eligible for surgery. The target action date for the FDA decision is Oct 28, 2018.
Approval of new drugs will further boost the top line.
We expect a solid performance from the company in the coming quarters as well.
Regeneron currently sports 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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