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Regeneron (REGN) Up on Higher Dose Eye Drug Studies Success
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Shares of Regeneron Pharmaceuticals, Inc. (REGN - Free Report) gained 18.85% on Sep 8 after it announced that the two studies evaluating aflibercept 8 mg with 12- and 16-week dosing regimens in patients with diabetic macular edema (DME) and wet age-related macular degeneration (wAMD) were successful.
Please note that aflibercept injection 2mg is approved under the brand name Eylea for treating patients with wAMD, macular edema following retinal vein occlusion (RVO), DME, and diabetic retinopathy (DR).
Eylea is Regeneron’s lead drug. The company is evaluating a higher dose of aflibercept with less frequent injections in the targeted population.
Data from the PHOTON trial in DME and the PULSAR trial in wAMD showed that aflibercept 8 mg 12- and 16-week dosing regimens achieved non-inferiority in vision gains compared to the 8-week dosing regimen of Eylea.
Of DME patients, 91% and 89% were rapidly initiated and maintained on 12- and 16-week dosing intervals (without the need for regimen modification) through week 48, respectively.
Of wAMD patients, 79% and 77% were rapidly initiated and maintained on 12- and 16-week dosing intervals (without the need for regimen modification) through week 48, respectively.
These trials further showed that around 90% of patients with DME and almost 80% of patients with wAMD were able to continue a 16-week dosing regimen while maintaining the safety profile.
Regeneron is jointly developing aflibercept 8 mg with Bayer AG (BAYRY - Free Report) .
While Regeneron records net product sales of Eylea in the United States, Bayer records net product sales of the drug outside the United States. Regeneron records its share of profits/losses in connection with sales of Eylea outside the United States.
REGN’s shares have gained 12.3% in the year so far against the industry’s decline of 24%.
Image Source: Zacks Investment Research
Growth in Eylea through additional label expansions and a promising late-stage pipeline should set the momentum for growth. Solid demand for Eylea and asthma drug Dupixent has fueled the top line. Sales of Eylea in the United States came in at $3.1 billion in the first six months of 2022.
However, stiff competition from the potential entry of generics and new treatment options weighs on Eylea and has been an overhang on Regeneron’s shares in recent months.
In January 2022, Roche (RHHBY - Free Report) won FDA approval for Vabysmo (faricimab-svoa) for the treatment of wAMD and DME. Roche has designed Vabysmo to block pathways involving Ang-2 and VEGF-A. It has ongoing long-term extension studies for Vabysmo in people with nAMD and DME.
Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of Dynavax have surpassed estimates in two of the trailing four quarters.
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Regeneron (REGN) Up on Higher Dose Eye Drug Studies Success
Shares of Regeneron Pharmaceuticals, Inc. (REGN - Free Report) gained 18.85% on Sep 8 after it announced that the two studies evaluating aflibercept 8 mg with 12- and 16-week dosing regimens in patients with diabetic macular edema (DME) and wet age-related macular degeneration (wAMD) were successful.
Please note that aflibercept injection 2mg is approved under the brand name Eylea for treating patients with wAMD, macular edema following retinal vein occlusion (RVO), DME, and diabetic retinopathy (DR).
Eylea is Regeneron’s lead drug. The company is evaluating a higher dose of aflibercept with less frequent injections in the targeted population.
Data from the PHOTON trial in DME and the PULSAR trial in wAMD showed that aflibercept 8 mg 12- and 16-week dosing regimens achieved non-inferiority in vision gains compared to the 8-week dosing regimen of Eylea.
Of DME patients, 91% and 89% were rapidly initiated and maintained on 12- and 16-week dosing intervals (without the need for regimen modification) through week 48, respectively.
Of wAMD patients, 79% and 77% were rapidly initiated and maintained on 12- and 16-week dosing intervals (without the need for regimen modification) through week 48, respectively.
These trials further showed that around 90% of patients with DME and almost 80% of patients with wAMD were able to continue a 16-week dosing regimen while maintaining the safety profile.
Regeneron is jointly developing aflibercept 8 mg with Bayer AG (BAYRY - Free Report) .
While Regeneron records net product sales of Eylea in the United States, Bayer records net product sales of the drug outside the United States. Regeneron records its share of profits/losses in connection with sales of Eylea outside the United States.
REGN’s shares have gained 12.3% in the year so far against the industry’s decline of 24%.
Image Source: Zacks Investment Research
Growth in Eylea through additional label expansions and a promising late-stage pipeline should set the momentum for growth. Solid demand for Eylea and asthma drug Dupixent has fueled the top line. Sales of Eylea in the United States came in at $3.1 billion in the first six months of 2022.
However, stiff competition from the potential entry of generics and new treatment options weighs on Eylea and has been an overhang on Regeneron’s shares in recent months.
In January 2022, Roche (RHHBY - Free Report) won FDA approval for Vabysmo (faricimab-svoa) for the treatment of wAMD and DME. Roche has designed Vabysmo to block pathways involving Ang-2 and VEGF-A. It has ongoing long-term extension studies for Vabysmo in people with nAMD and DME.
Regeneron currently carries a Zacks Rank #3 (Hold). A better-ranked stock in this space is Dynavax (DVAX - Free Report) , which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of Dynavax have surpassed estimates in two of the trailing four quarters.