RBC Capital analyst Brian Abrahams says that while today’s approval of Regeneron Pharmaceuticals’ (REGN) pozelimab in Chaple disease is “only incremental news for the company,” the news intimates a likely near-term approval of high-dose Eylea. Regeneron has emphasized that the FDA is prioritizing the review of its high-dose aflibercept resubmission following a manufacturing related Complete Response Letter in June, and noted the Agency will tie the review of both pozelimab and high-dose aflibercept together to expedite the review process given these drugs are produced under the same Catalent (CTLT) filling line, the analyst tells investors in a research note. The shares appear to be up on the positive development which further de-risks high-dose Eylea’s approval prospects and timelines, says RBC. However, the firm believes Regeneron shares are trading closer to fair value.
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