Kiniksa Pharmaceuticals International KNSA is making steady progress, with strong commercial performance of Arcalyst, the first FDA-approved therapy for patients aged 12 years and older with recurrent pericarditis, a severe, debilitating and chronic autoinflammatory cardiovascular disease. The product has consistently delivered robust revenue growth, supported by increasing physician adoption and expanding patient awareness.
Arcalyst: Key Growth Driver of Kiniksa
Arcalyst is a once-weekly subcutaneous inhibitor of IL-1α and IL-1β, originally discovered by Regeneron Pharmaceuticals REGN. The therapy is FDA-approved for recurrent pericarditis, cryopyrin-associated periodic syndromes (CAPS) including familial cold autoinflammatory syndrome and muckle-wells syndrome and deficiency of IL-1 receptor antagonist (DIRA).
The product was licensed from REGN in 2017 under an exclusive worldwide agreement (excluding the Middle East and North Africa). Following FDA approval in March 2021 for recurrent pericarditis, Arcalyst has become Kiniksa's flagship commercial product, while also retaining approvals for CAPS and DIRA. The therapy is marketed across the United States through specialty pharmacies, with Kiniksa leading commercialization and sharing profits with Regeneron. The company is also expanding Arcalyst's global reach through its partnership with Huadong Pharmaceutical in China and continues to strengthen manufacturing capabilities while exploring additional indications, including cardiac sarcoidosis.
The FDA granted Breakthrough Therapy designation to the drug for recurrent pericarditis in 2019, followed by Orphan Drug exclusivity in the United States in 2021. In the same year, the European Commission granted Orphan Drug Designation for the treatment of idiopathic pericarditis, further validating its therapeutic potential.
Kiniksa benefits from meaningful product revenues generated by Arcalyst. The company expects 2026 Arcalyst net product revenues to be in the range of $930 million to $945 million, compared to prior guidance of $900 million to $920 million.
Over the past three months, KNSA shares have risen 24.4% compared with the industry’s 2.2% growth.
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Pipeline Progress Fuels KNSA’s Growth Outlook
To extend its leadership in IL-1-targeted therapies, Kiniksa is advancing its next-generation IL-1 pipeline with KPL-387, a monoclonal antibody IL-1 receptor antagonist currently in a phase II/III study for recurrent pericarditis. Phase II dose-finding data are expected in the second half of 2026, with the pivotal phase III study anticipated to begin by year-end. The company is conducting a supplemental phase II study to evaluate the transition of patients from standard therapies to KPL-387 monotherapy.
Another pipeline candidate, KPL-1161, an Fc-modified monoclonal antibody that acts as an IL-1 receptor antagonist and designed for quarterly subcutaneous dosing. The candidate is currently in preclinical development, with a phase I first-in-human study expected to commence by the end of 2026.
Kiniksa Pharmaceuticals International, plc Price and Consensus
Kiniksa Pharmaceuticals International, plc price-consensus-chart | Kiniksa Pharmaceuticals International, plc Quote
KNSA's Zacks Rank & Estimates
Kiniksa currently sports a Zacks Rank #1 (Strong Buy). Over the past 60 days, earnings per share estimates for Kiniksa have risen from $1.09 to $1.24 and the same for 2027 have also increased from $1.54 to $1.70.
Other Stocks to Consider
Some other top-ranked stocks in the biotech sector are Immunocore IMCR and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Immunocore’s 2026 loss per share have improved from 88 cents to earnings per share of 6 cents. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR shares have lost 12% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 46.66%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased to $2.97 from $1.50. Over the same period, EPS estimates for 2027 have risen to $4.81 from $2.91. LQDA shares have gained 123% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
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This article originally published on Zacks Investment Research (zacks.com).