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Oct 27, 2026Regulatory decisionUpdated

Kiniksa raises 2026 ARCALYST sales guidance, confirms KPL-387 data timing

Kiniksa lifted its 2026 ARCALYST revenue outlook to $1.045-$1.050 billion and said pivotal Phase 3 data on KPL-387 are still expected in the second half of 2027.

Kiniksa Pharmaceuticals International reported third quarter 2026 results on October 27, 2026 and raised its full-year outlook for ARCALYST. The company said it now expects 2026 ARCALYST net sales of between $1.045 and $1.050 billion, up from its previous range of between $980 and $995 million.1

On the pipeline, Kiniksa said it continues to enroll and dose patients in PASTORALE, the pivotal Phase 3 trial of KPL-387 evaluating once monthly subcutaneous dosing, with data expected in the second half of 2027, and a goal of bringing the treatment to patients in the 2028/2029 timeframe.1 The company is also running a supplemental Phase 2 study evaluating the transition of patients from standard therapies to KPL-387 monotherapy dosing and administration.1

For KPL-1161, an Fc-modified antibody targeting IL-1R1, Kiniksa said it expects to initiate a Phase 1 first-in-human trial, targeting quarterly subcutaneous dosing, by the end of 2026.1

On ARCALYST's commercial reach, the company said roughly 23% of an estimated 14,000 annual multiple-recurrence patients were actively on ARCALYST treatment as of the end of the third quarter of 2026,1 and that more than 5,450 prescribers have written ARCALYST prescriptions for recurrent pericarditis since launch.1

Quarterly revenue showed the scale of that growth: ARCALYST net product revenue was $286.0 million for the third quarter of 2026.1 Net income for the quarter was $47.3 million, compared to $18.4 million for the third quarter of 2025.1

On the balance sheet, Kiniksa said it had $568.8 million of cash, cash equivalents, and short-term investments and no debt as of September 30, 2026,1 and that it expects its current operating plan to remain cash flow positive on an annual basis.1

Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.