The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Regeneron received a response letter from the FDA on June 27, 2023, declining to approve its application for an 8mg dose of aflibercept, marketed in the U.S. as Eylea. The Company claims that the denial is due to an ongoing review of findings at a third-party filler. Based on this news, shares of Regeneron dropped more than 9% on the same day.
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