Shares of Regeneron Pharmaceuticals Inc. (REGN - Free Report) have gained 11% in the past six months, against a decline of 9.6% for the industry.
Tarrytown, New York-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), and macular edema following retinal vein occlusion, which includes macular edema following central retinal vein occlusion and macular edema following branch retinal vein occlusion.
Meanwhile, Regeneron is working on expanding Eylea’s label into additional indications. The FDA recently approved a 12-week dosing interval of Eylea injection in patients with wet AMD based on physician's assessment.
Consequently, Eylea is now the only anti-VEGF drug for the treatment of wet AMD that offers the flexibility to optimally treat patients, regardless of whether they require fixed-interval dosing of 4, 8 or 12 weeks. The FDA also accepted for review the supplemental Biologics License Application (sBLA) of Eylea for the treatment of diabetic retinopathy, with a target action date of May 13, 2019.
Label expansion of other approved drugs will also boost sales for the company.
Dupixent’s performance has been strong so far after the drug was approved last year for the treatment of adults with moderate-to-severe atopic dermatitis (AD). 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.
In October 2018, the FDA approved Dupixent as an add-on maintenance therapy in patients aged 12 years or older with moderate-to-severe asthma. The drug is also under review in Europe for this indication and a decision is expected in the second quarter of 2019. The FDA has also accepted for priority review the sBLA for AD in adolescent patients and set a target action date of Mar 11, 2019.
Regeneron is working to expand its portfolio/pipeline. In September 2018, the FDA approved Libtayo for the treatment of patients with metastatic or locally advanced CSCC who are not candidates for curative surgery or curative radiation. The drug is also under review in Europe and a decision is expected in the first half of 2019. Libtayo is also being evaluated for the treatment of non-small cell lung cancer in a phase III study, which is currently enrolling.
The company is also working to expand its PCSK9 inhibitor Praluent’s label. The FDA approved Praluent for the treatment of patients with heterozygous familial hypercholesterolemia (HeFH) undergoing apheresis. The agency also accepted an sBLA for Praluent as a potential treatment to reduce major adverse cardiovascular events and had set a target action date of Apr 28, 2019.
Approval of new drugs will further boost the top line. Earlier, the company and partner Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) 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.
We expect a solid performance from the company in the coming quarters as well.
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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