Regeneron Pharmaceuticals, Inc. (REGN, Financial) has encountered a hurdle as the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the company's proposal for longer dosing intervals of Eylea HD injections. The supplemental biologics license application aimed to extend the dosing intervals beyond the current maximum of 16 weeks for the treatment of conditions like wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.
While the FDA's response did not indicate concerns about the safety or efficacy of Eylea HD in its approved uses and existing dosing schedules, it disagreed with Regeneron's plan to introduce longer intervals. Currently, Eylea HD is approved for dosing every 8 to 16 weeks for certain conditions and every 8 to 12 weeks for others, after an initial series of monthly injections.
Regeneron is reviewing the FDA's feedback and plans to outline its next steps in response to the decision. Following the announcement, Regeneron's share price saw a slight decline of 1%, trading at $556.64 in the morning session.
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 63.30% from the current price of $556.00. 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 $905.96, suggesting a upside of 62.94% from the current price of $556. 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.
