Leerink Partners analyst David Risinger has maintained their bullish stance on REGN stock, giving a Buy rating yesterday.
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David Risinger has given his Buy rating due to a combination of factors surrounding Regeneron’s ongoing developments and future potential. One key aspect is the progress with EYLEA HD, where the FDA has extended the PDUFA date to the fourth quarter of 2025. This extension includes a Chemistry, Manufacturing, and Controls Prior-Approval Supplement for the EYLEA HD prefilled syringe and a supplemental Biologics License Application for treating macular edema following retinal vein occlusion and broadening the dosing schedule.
Additionally, Risinger anticipates the potential FDA approval of odronextamab, a CD20xCD3 bispecific antibody for lymphoma, which is also expected in the fourth quarter of 2025. Despite the delay caused by a general FDA site inspection at Catalent, the contract manufacturer, Risinger remains optimistic about Regeneron’s pipeline. Furthermore, the upcoming results from the Phase 3 NIMBLE trial evaluating the pozelimab + cemdisiran combination in generalized myasthenia gravis, expected in the third quarter of 2025, add to the potential catalysts for the company’s growth.