Regeneron Pharmaceuticals Inc, REGN, FDA Calendar, PDUFA Date

Company Name	Regeneron Pharmaceuticals Inc REGN
Drug Name	ARCALYST (sBLA)
Event Name	FDA decision regarding the technology transfer to Samsung Biologics Co., Ltd. as replacement CDMO for ARCALYST
Event Date	06/19/2026
Outcome Date
Outcome	Pending
Drug Status	ARCALYST was discovered and developed by Regeneron Pharmaceuticals, Inc. In 2017, Regeneron granted Kiniksa an exclusive license to develop and commercialize ARCALYST worldwide, excluding Israel, Egypt, Turkey and select countries in the Middle East and North Africa
Rival Drugs
Market Potential
Other Approvals	ARCALYST is approved for the treatment of Cryopyrin-Associated Periodic Syndromes; Deficiency of Interleukin-1 Receptor Antagonist; Recurrent Pericarditis
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