Regeneron Pharmaceuticals (REGN, Financial) has announced a significant development as the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for EYLEA HD Injection 8 mg for Priority Review. The application seeks to approve EYLEA HD for treating macular edema following retinal vein occlusion (RVO) and to expand the dosing schedule to include a 4-week interval across approved uses.
The FDA has set a target action date of August 19, 2025, benefiting from the use of a Priority Review voucher, which accelerates the review process. The sBLA submission is supported by comprehensive clinical data from the EYLEA HD program, notably including results from the Phase 3 QUASAR trial that examined EYLEA HD's efficacy in RVO treatment.
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 $909.08 with a high estimate of $1,152.00 and a low estimate of $575.00. The average target implies an upside of 65.50% from the current price of $549.28. 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 65% from the current price of $549.28. 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.
