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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) recently announced that its supplemental biologics license application (sBLA) for the ophthalmology drug, Eylea (aflibercept), has been accepted by the FDA for priority review. Eylea is a VEGF inhibitor formulated as an injection for the eye.
The sBLA is seeking label expansion of Eylea for the treatment of retinopathy of prematurity (ROP) in preterm infants.
With the FDA granting a priority review to the sBLA, a decision from the regulatory body is expected on Feb 11, 2023.
The latest sBLA was based on data from two phase III studies – FIREFLEYE and BUTTERFLEYE – which evaluated Eylea (0.4 mg) compared to laser photocoagulation (laser) in infants with ROP, a leading cause of childhood blindness in the world.
Data from both studies showed that 80% of infants treated with Eylea achieved an absence of both active ROP and unfavorable structural outcomes at 52 weeks of age.
However, both studies did not meet the primary endpoint of non-inferiority as laser demonstrated comparable levels of efficacy, which was higher than what has been historically observed in similar ROP studies.
While Regeneron is the lead sponsor of the BUTTERFLEYE study, Bayer AG (BAYRY - Free Report) is the lead sponsor of the FIREFLEYE study.
The FDA granted orphan drug designation to Eylea for the treatment of ROP in July 2019.
Shares of Regeneron have risen 15.3% so far this year against the industry’s decline of 27.8%.
Image Source: Zacks Investment Research
Regeneron is jointly developing Eylea with Bayer.
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.
Eylea injection (2mg) is approved for treating patients with neovascular (Wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.
Sales of Eylea in the United States came in at $3.1 billion in the first six months of 2022. Successful label expansion into additional indications should boost sales further in the days ahead.
However, stiff competition from new treatment options remains an overhang.
Loss per share estimates for Acadia have narrowed 0.8% for 2022 and 11.7% for 2023 in the past 60 days.
Earnings of Acadia surpassed estimates in two of the trailing four quarters and missed on the remaining two occasions. ACAD delivered an earnings surprise of 6.83%, on average.
Loss per share estimates for ORIC Pharmaceuticals have narrowed 5.9% for 2022 and 7.3% for 2023 in the past 60 days.
Earnings of ORIC Pharmaceuticals surpassed estimates in three of the trailing four quarters and missed on the other occasion. ORIC delivered an earnings surprise of 8.85%, on average.
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Regeneron's (REGN) Eylea sBLA Gets FDA's Priority Review
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) recently announced that its supplemental biologics license application (sBLA) for the ophthalmology drug, Eylea (aflibercept), has been accepted by the FDA for priority review. Eylea is a VEGF inhibitor formulated as an injection for the eye.
The sBLA is seeking label expansion of Eylea for the treatment of retinopathy of prematurity (ROP) in preterm infants.
With the FDA granting a priority review to the sBLA, a decision from the regulatory body is expected on Feb 11, 2023.
The latest sBLA was based on data from two phase III studies – FIREFLEYE and BUTTERFLEYE – which evaluated Eylea (0.4 mg) compared to laser photocoagulation (laser) in infants with ROP, a leading cause of childhood blindness in the world.
Data from both studies showed that 80% of infants treated with Eylea achieved an absence of both active ROP and unfavorable structural outcomes at 52 weeks of age.
However, both studies did not meet the primary endpoint of non-inferiority as laser demonstrated comparable levels of efficacy, which was higher than what has been historically observed in similar ROP studies.
While Regeneron is the lead sponsor of the BUTTERFLEYE study, Bayer AG (BAYRY - Free Report) is the lead sponsor of the FIREFLEYE study.
The FDA granted orphan drug designation to Eylea for the treatment of ROP in July 2019.
Shares of Regeneron have risen 15.3% so far this year against the industry’s decline of 27.8%.
Image Source: Zacks Investment Research
Regeneron is jointly developing Eylea with Bayer.
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.
Eylea injection (2mg) is approved for treating patients with neovascular (Wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.
Sales of Eylea in the United States came in at $3.1 billion in the first six months of 2022. Successful label expansion into additional indications should boost sales further in the days ahead.
However, stiff competition from new treatment options remains an overhang.
Zacks Rank & Other Stocks to Consider
Regeneron currently carries a Zacks Rank #2 (Buy). Other stocks worth considering in the biotech sector are Acadia Pharmaceuticals Inc. (ACAD - Free Report) and ORIC Pharmaceuticals, Inc. (ORIC - Free Report) , both carrying the same Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for Acadia have narrowed 0.8% for 2022 and 11.7% for 2023 in the past 60 days.
Earnings of Acadia surpassed estimates in two of the trailing four quarters and missed on the remaining two occasions. ACAD delivered an earnings surprise of 6.83%, on average.
Loss per share estimates for ORIC Pharmaceuticals have narrowed 5.9% for 2022 and 7.3% for 2023 in the past 60 days.
Earnings of ORIC Pharmaceuticals surpassed estimates in three of the trailing four quarters and missed on the other occasion. ORIC delivered an earnings surprise of 8.85%, on average.