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Regeneron (REGN) Loses 13% in Three Months: What Lies Ahead?
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Shares of Regeneron Pharmaceuticals, Inc. (REGN - Free Report) have lost 13.3% in the last three months compared with the industry’s decline of 5.2%.
The ride has been rough for this big biotech company of late. Last week, the FDA issued a complete response letter (CRL) to the company’s biologics license application seeking approval for the 8 mg dose strength of aflibercept for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR).
Regeneron has reported that the cause of the CRL is only an ongoing review of inspection findings at a third-party filler. The company reaffirmed that the CRL was not levied due to issues with the clinical efficacy or safety, trial design and labeling or drug substance manufacturing of aflibercept 8 mg. Furthermore, the company also stated that the FDA had not requested any additional clinical data or studies for the drug candidate.
Image Source: Zacks Investment Research
However, the CRL still disappointed investors and shares fell. Regeneron is looking to bolster its portfolio with the approval of a higher dose of its blockbuster drug aflibercept. A regulatory application has also been submitted for treating wet AMD and DME in the European Union (EU) and Japan.
We note that a 2 mg dose of aflibercept is already approved under the brand name Eylea for various ophthalmology indications.
Eylea had been a consistent performer for Regeneron, but sales in the last two quarters were under pressure due to increasing competition from Roche’s (RHHBY - Free Report) Vabysmo.
In the first quarter, sales in the United States were $1.4 billion, down 6% year over year, primarily due to an increase in sales-related deductions.
Hence, REGN is desperate to get aflibercept 8 mg approved to offset this loss.
In January 2022, Roche won FDA approval for Vabysmo (faricimab-svoa) to treat wAMD and DME. Roche has designed Vabysmo to block pathways involving Ang-2 and VEGF-A. The European Commission also approved Vabysmo (faricimab) 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.
Meanwhile, Regeneron’s top line is being boosted by its share of profits/losses in connection with global sales of Dupixent. Its partner, Sanofi (SNY - Free Report) , records global net product sales of Dupixent. Dupixent maintains its dominant position, driven by continued strong demand in the approved indications, atopic dermatitis (AD), asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis and prurigo nodularis.
Regeneron also records net product sales of Praluent in the United States and Sanofi records net product sales of Praluent outside the United States and pays the company a royalty on such sales.
Regeneron is also looking to diversify in the lucrative oncology space with Libtayo (cemiplimab-rwlc), indicated in certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma and advanced non-small cell lung cancer.
Image: Bigstock
Regeneron (REGN) Loses 13% in Three Months: What Lies Ahead?
Shares of Regeneron Pharmaceuticals, Inc. (REGN - Free Report) have lost 13.3% in the last three months compared with the industry’s decline of 5.2%.
The ride has been rough for this big biotech company of late. Last week, the FDA issued a complete response letter (CRL) to the company’s biologics license application seeking approval for the 8 mg dose strength of aflibercept for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR).
Regeneron has reported that the cause of the CRL is only an ongoing review of inspection findings at a third-party filler. The company reaffirmed that the CRL was not levied due to issues with the clinical efficacy or safety, trial design and labeling or drug substance manufacturing of aflibercept 8 mg. Furthermore, the company also stated that the FDA had not requested any additional clinical data or studies for the drug candidate.
Image Source: Zacks Investment Research
However, the CRL still disappointed investors and shares fell. Regeneron is looking to bolster its portfolio with the approval of a higher dose of its blockbuster drug aflibercept. A regulatory application has also been submitted for treating wet AMD and DME in the European Union (EU) and Japan.
We note that a 2 mg dose of aflibercept is already approved under the brand name Eylea for various ophthalmology indications.
Eylea had been a consistent performer for Regeneron, but sales in the last two quarters were under pressure due to increasing competition from Roche’s (RHHBY - Free Report) Vabysmo.
In the first quarter, sales in the United States were $1.4 billion, down 6% year over year, primarily due to an increase in sales-related deductions.
Hence, REGN is desperate to get aflibercept 8 mg approved to offset this loss.
In January 2022, Roche won FDA approval for Vabysmo (faricimab-svoa) to treat wAMD and DME. Roche has designed Vabysmo to block pathways involving Ang-2 and VEGF-A. The European Commission also approved Vabysmo (faricimab) 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.
Meanwhile, Regeneron’s top line is being boosted by its share of profits/losses in connection with global sales of Dupixent. Its partner, Sanofi (SNY - Free Report) , records global net product sales of Dupixent. Dupixent maintains its dominant position, driven by continued strong demand in the approved indications, atopic dermatitis (AD), asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis and prurigo nodularis.
Regeneron also records net product sales of Praluent in the United States and Sanofi records net product sales of Praluent outside the United States and pays the company a royalty on such sales.
Regeneron is also looking to diversify in the lucrative oncology space with Libtayo (cemiplimab-rwlc), indicated in certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma and advanced non-small cell lung cancer.
Regeneron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.