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Regeneron (REGN) Eylea sBLA for Extended Regimen Accepted

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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) recently announced that its supplemental biologics License Application (sBLA) for ophthalmology drug Eylea has been accepted by the FDA for review.

Eylea is a VEGF inhibitor formulated as an injection for the eye.

The sBLA is seeking label expansion of the drug for every 16-week 2 mg dosing regimen (after initial monthly doses) in patients with diabetic retinopathy (DR).

The regulatory body has set a target action date of Feb 28, 2023.

The sBLA is supported by data from the phase III study, PANORAMA, which evaluated every 8- and 16-week Eylea dosing regimens, versus sham, in patients with severe non-proliferative diabetic retinopathy (NPDR) without diabetic macular edema (DME). The study met its primary endpoint.

The submission was also supported by data from the NIH-sponsored Protocol W study evaluating the 16-week dosing Eylea regimen in patients with moderate to severe NPDR without center-involved DME versus sham.

We note that Eylea was approved for the treatment of all stages of DR with a dosing regimen of every 4 or 8 weeks after five initial monthly doses in 2019. A potential approval for the 16-week dosing regimen would provide a longer treatment interval and additional dosing flexibility, alongside approved every 4- and 8-week dosing regimens.

Eylea is also approved for the treatment of neovascular (Wet) age-related macular degeneration, macular edema following retinal vein occlusion and DME.

DR is one the leading cause of blindness among working-age American adults, affecting more than 8 million people in the country.

Shares of Regeneron have lost 6.3% in the year so far compared with the industry’s decline of 23.3%.

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Regeneron has a collaboration agreement with Bayer (BAYRY - Free Report) for Eylea. Regeneron records net product sales of Eylea in the United States. Bayer records net product sales of the drug outside the United States.

Demand for Eylea maintains momentum for the company. Recent label expansions into additional indications have boosted sales and should maintain momentum. The company is working on expanding the drug’s label further, which should boost performance.

However, Eylea will lose patent protection in a couple of years. It is Regeneron’s top growth driver, and a slowdown in sales will affect the company.

To that end, Regeneron is trying to diversify its revenue base. The company recently announced that it will buy partner Sanofi’s (SNY - Free Report) stake in their collaboration agreement for the oncology drug Libtayo (cemiplimab).

Per the terms of the deal, Sanofi will transfer the rights to develop, commercialize and manufacture Libtayo entirely to Regeneron worldwide for a defined transition period. In return, Regeneron will make an upfront payment of $900 million to Sanofi. SNY will also be entitled to receive an 11% royalty on the worldwide net sales of Libtayo. REGN is looking to diversify in the lucrative oncology space, and the buyout of Libtayo was a step forward in the same direction.

Regeneron currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech space is Sesen Bio (SESN - Free Report) which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Loss estimates for SESN for 2022 have narrowed to 44 cents from a loss of 46 cents in the past 60 days. Sesen surpassed estimates in all of the trailing four quarters, the average surprise being 69.94%.