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Regeneron (REGN) Gains 13% in 1 Month on FDA Nod For Eylea HD
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It has been an eventful month for Regeneron Pharmaceuticals, Inc. (REGN - Free Report) , which managed to reverse its trajectory in the year so far with the recent FDA approval of a higher dose of aflibercept.
Shares of the company have gained 13% in one month compared with the industry’s growth of 1.6%.
Earlier in the month, the FDA finally approved aflibercept 8 mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR) under the brand name Eylea HD.
Image Source: Zacks Investment Research
The recommended dose for the drug is 8 mg every 4 weeks for the first 3 months across all indications, followed by 8 mg every 8 to 16 weeks (2 to 4 months) in wAMD and DME and every 8 to 12 weeks (2 to 3 months) for DR. The approval was based on the 48-week results of two studies, PULSAR and PHOTON. These two double-masked, active-controlled pivotal trials compared Eylea HD to aflibercept injection at 2 mg.
We note that a 2 mg dose of aflibercept is already approved under the brand name Eylea for various ophthalmology indications.
The FDA earlier issued a complete response letter to the company’s biologics license application seeking approval for the 8 mg dose of aflibercept for these indications, which disappointed investors.
The approval of Eylea HD will somewhat relieve investors, as Eylea had been a consistent performer for Regeneron, but sales in the last few quarters have been under pressure due to increasing competition from Roche’s (RHHBY - Free Report) Vabysmo for wAMD and DME. Moreover, impending competition from biosimilars looms large over the drug.
The uptake of Roche’s Vabysmo has been outstanding. Roche has designed Vabysmo to block pathways involving Ang-2 and VEGF-A. The European Commission also approved Vabysmo for these indications.
Please note that Regeneron co-developed Eylea with the HealthCare unit of Bayer AG (BAYRY - Free Report) . Regeneron records net product sales of Eylea in the United States and Bayer records net product sales of Eylea outside the United States. Regeneron records its share of profits/losses in connection with sales of Eylea outside the United States.
Concurrently, the FDA approved pozelimab-bbfg for the treatment of adult and pediatric patients 1 year of age and older with CHAPLE disease, also known as CD55-deficient protein-losing enteropathy. The candidate has been approved under the brand name Veopoz.
Per Regeneron, Veopoz is the first and only treatment indicated specifically for CHAPLE, an ultra-rare hereditary disease that can cause potentially life-threatening gastrointestinal and cardiovascular symptoms.
Regeneron Pharmaceuticals, Inc. Price and Consensus
Regeneron is also looking to diversify its portfolio. The company recently announced that it will acquire clinical-stage biotechnology company Decibel Therapeutics, Inc. for $213 million to expand its gene therapy programs for hearing loss.
Decibel’s lead investigational gene therapy, DB-OTO, is in a phase I/II study. The pipeline progress has been encouraging as well. The European Medicines Agency recently accepted the marketing authorization application (MAA) for its pipeline candidate, odronextamab.
The MAA is seeking approval for the candidate to treat adult patients with relapsed/refractory (R/R) follicular lymphoma or R/R diffuse large B-cell lymphoma who have progressed after at least two prior systemic therapies.
Regeneron is looking to solidify its presence in the lucrative oncology space.
Its portfolio already includes an approved PD-1 inhibitor, Libtayo, which is approved to treat people with a type of skin cancer called cutaneous squamous cell carcinoma that has spread or cannot be cured by surgery or radiation. The company is also evaluating multiple CD28 costimulatory bispecific antibodies, including PSMAxCD28, EGFRxCD28, MUC16xCD28 and CD22xCD28, in ongoing phase I studies in a variety of tumor settings in combination with Libtayo or in combination with corresponding CD3 bispecific.
The successful development of additional drugs will diversify its product base.
Image: Bigstock
Regeneron (REGN) Gains 13% in 1 Month on FDA Nod For Eylea HD
It has been an eventful month for Regeneron Pharmaceuticals, Inc. (REGN - Free Report) , which managed to reverse its trajectory in the year so far with the recent FDA approval of a higher dose of aflibercept.
Shares of the company have gained 13% in one month compared with the industry’s growth of 1.6%.
Earlier in the month, the FDA finally approved aflibercept 8 mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR) under the brand name Eylea HD.
Image Source: Zacks Investment Research
The recommended dose for the drug is 8 mg every 4 weeks for the first 3 months across all indications, followed by 8 mg every 8 to 16 weeks (2 to 4 months) in wAMD and DME and every 8 to 12 weeks (2 to 3 months) for DR. The approval was based on the 48-week results of two studies, PULSAR and PHOTON. These two double-masked, active-controlled pivotal trials compared Eylea HD to aflibercept injection at 2 mg.
We note that a 2 mg dose of aflibercept is already approved under the brand name Eylea for various ophthalmology indications.
The FDA earlier issued a complete response letter to the company’s biologics license application seeking approval for the 8 mg dose of aflibercept for these indications, which disappointed investors.
The approval of Eylea HD will somewhat relieve investors, as Eylea had been a consistent performer for Regeneron, but sales in the last few quarters have been under pressure due to increasing competition from Roche’s (RHHBY - Free Report) Vabysmo for wAMD and DME. Moreover, impending competition from biosimilars looms large over the drug.
The uptake of Roche’s Vabysmo has been outstanding. Roche has designed Vabysmo to block pathways involving Ang-2 and VEGF-A. The European Commission also approved Vabysmo for these indications.
Please note that Regeneron co-developed Eylea with the HealthCare unit of Bayer AG (BAYRY - Free Report) . Regeneron records net product sales of Eylea in the United States and Bayer records net product sales of Eylea outside the United States. Regeneron records its share of profits/losses in connection with sales of Eylea outside the United States.
Concurrently, the FDA approved pozelimab-bbfg for the treatment of adult and pediatric patients 1 year of age and older with CHAPLE disease, also known as CD55-deficient protein-losing enteropathy. The candidate has been approved under the brand name Veopoz.
Per Regeneron, Veopoz is the first and only treatment indicated specifically for CHAPLE, an ultra-rare hereditary disease that can cause potentially life-threatening gastrointestinal and cardiovascular symptoms.
Regeneron Pharmaceuticals, Inc. Price and Consensus
Regeneron Pharmaceuticals, Inc. price-consensus-chart | Regeneron Pharmaceuticals, Inc. Quote
Regeneron is also looking to diversify its portfolio. The company recently announced that it will acquire clinical-stage biotechnology company Decibel Therapeutics, Inc. for $213 million to expand its gene therapy programs for hearing loss.
Decibel’s lead investigational gene therapy, DB-OTO, is in a phase I/II study.
The pipeline progress has been encouraging as well. The European Medicines Agency recently accepted the marketing authorization application (MAA) for its pipeline candidate, odronextamab.
The MAA is seeking approval for the candidate to treat adult patients with relapsed/refractory (R/R) follicular lymphoma or R/R diffuse large B-cell lymphoma who have progressed after at least two prior systemic therapies.
Regeneron is looking to solidify its presence in the lucrative oncology space.
Its portfolio already includes an approved PD-1 inhibitor, Libtayo, which is approved to treat people with a type of skin cancer called cutaneous squamous cell carcinoma that has spread or cannot be cured by surgery or radiation. The company is also evaluating multiple CD28 costimulatory bispecific antibodies, including PSMAxCD28, EGFRxCD28, MUC16xCD28 and CD22xCD28, in ongoing phase I studies in a variety of tumor settings in combination with Libtayo or in combination with corresponding CD3 bispecific.
The successful development of additional drugs will diversify its product base.
Regeneron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.