Regeneron Pharmaceuticals (REGN, Financial) has announced that the U.S. Food and Drug Administration has granted Priority Review status to its supplemental Biologics License Application for EYLEA HD Injection at a dosage of 8 mg. This application seeks to extend the use of EYLEA HD for treating macular edema following retinal vein occlusion (RVO) and to broaden its dosing schedule to a 4-week regimen across all approved uses.
The FDA has set a target decision date for August 19, 2025, facilitated by the application of a Priority Review voucher. This accelerated review process underscores the potential importance of EYLEA HD in offering enhanced treatment options for patients. The application is backed by comprehensive data from the EYLEA HD clinical program, notably including findings from the Phase 3 QUASAR trial, which explored the drug's effectiveness in RVO.
Wall Street Analysts Forecast
Based on the one-year price targets offered by 25 analysts, the average target price for Regeneron Pharmaceuticals Inc (REGN, Financial) is $907.96 with a high estimate of $1,152.00 and a low estimate of $547.00. The average target implies an upside of 61.23% from the current price of $563.16. More detailed estimate data can be found on the Regeneron Pharmaceuticals Inc (REGN) Forecast page.
Based on the consensus recommendation from 28 brokerage firms, Regeneron Pharmaceuticals Inc's (REGN, Financial) average brokerage recommendation is currently 2.0, indicating "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.
Based on GuruFocus estimates, the estimated GF Value for Regeneron Pharmaceuticals Inc (REGN, Financial) in one year is $906.31, suggesting a upside of 60.93% from the current price of $563.16. GF Value is GuruFocus' estimate of the fair value that the stock should be traded at. It is calculated based on the historical multiples the stock has traded at previously, as well as past business growth and the future estimates of the business' performance. More detailed data can be found on the Regeneron Pharmaceuticals Inc (REGN) Summary page.
