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Regeneron Hopes Its High-Dose Aflibercept Will Ease Eylea Pressure

Execs Expect BCMA Bispecific To Stand Out In Competitive Space

Executive Summary

Eylea sales were below consensus for the second quarter in a row, but aflibercept 8mg approval in late June could offset the decline. Also, a late 2023 filing is planned for linvoseltamab in myeloma.

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UPDATED: Regeneron Wins Same-Day Veopoz, High-Dose Eylea US FDA Approvals

Veopoz (pozelimab) approval showed the FDA was reassured that Regeneron’s contract manufacturer is ready to supply high-dose Eylea, a key product for the company as competition picks up.

Regeneron Raises Possibility Of Quick CRL Resolution For High-Dose Eylea

On its earnings call, Regeneron said its 8mg formulation of aflibercept could obtain US FDA approval this quarter, despite receiving a complete response letter in June. Refiling’s fate tied to review of pozelimab, which is manufactured in the same plant with fill/finish concerns.

Regeneron Raises Possibility Of Quick CRL Resolution For High-Dose Eylea

On its Q2 earnings call, Regeneron said its 8mg formulation of aflibercept could obtain US FDA approval this quarter, despite receiving a complete response letter in June. Refiling’s fate tied to review of pozelimab.

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