The FDA decision on Kiniksa Pharmaceuticals International plc’s (KNSA) supplemental biologics license application related to the technology transfer of the manufacturing process for Arcalyst drug substance to Samsung Biologics Co., Ltd. is expected on June 19, 2026. Arcalyst (rilonacept), an interleukin-1 inhibitor, is approved by the FDA for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS), and Muckle-Wells Syndrome (MWS) in adults and children 12 years and older; maintenance of remission of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in adults and pediatric patients weighing 10 kg or more; and treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and children 12 years and older.Kiniksa licensed Arcalyst from Regeneron in 2017. The drug generated $214.3 million in net product revenue for Kiniksa in the first quarter of 2026, marking 56% year-over-year growth. For full-year 2026, Arcalyst is projected to generate between $930 million and $945 million in net product revenue.KNSA closed Tuesday’s (June 2, 2026) trading at $46.92, down 3.12%.