Kiniksa Sets Second-Half 2027 Data Date For Monthly Heart Drug, Eyes 2028-2029 Launch
Arcalyst is on track for over $1 billion in 2026 sales and is paying for the pipeline, management said.
Kiniksa Pharmaceuticals, which sells the heart-inflammation drug Arcalyst, expects pivotal data on its once-monthly follow-on KPL-387 in the second half of 2027, CEO Sanj K. Patel said on the company's Tuesday third-quarter earnings call. Patel said the company is "really looking forward to potentially launching this drug in the 28-29 timeframe."
A monthly shot to widen the market
Patel said KPL-387 "could help grow the market" by enabling once-monthly sub-Q dosing. Kiniksa also expects its quarterly follow-on, KPL-1161, to enter a first clinical trial by the end of this year.
An analyst from JP Morgan noted the second-half 2027 guidance was new that day and asked what enrollment and site-activation progress supported it. Patel pointed to "massive momentum" with investigators, and Chief Medical Officer John Paolini said global trial sites are listed on clinicaltrials.gov. Neither gave enrollment figures.
President and COO Ross Moat said company research on the target profile drew encouraging responses: about 75% of patients preferred it, and 92% of physicians indicated a high likelihood to prescribe it. He added that "everything's kind of data dependent."
Paolini said a separate study covers moving patients from NSAIDs, colchicine, corticosteroids or IL-1 inhibitors onto the 300 milligram monthly dose, with a 16-week primary endpoint period, to inform the label. He said plans for KPL-1161's first indication have not been announced.
Arcalyst pays for the pipeline
Kiniksa, a biopharmaceutical company focused on heart and blood vessel disease, sells Arcalyst for recurrent pericarditis, a painful inflammation of the sac around the heart. It raised its full-year Arcalyst sales guidance to $1.045 billion to $1.050 billion, putting the drug on track for more than $1 billion in 2026.
Arcalyst revenue grew 58% year over year to $286 million in the third quarter, executives said. Operating income rose to $54.2 million and net income to $47.3 million, and Arcalyst collaboration profit climbed 67% to $211.6 million. Cash ended the quarter at $568.8 million.
Penetration of the 14,000 patients a year with multiple recurrences reached 23%, Patel and Moat said, versus 18% at the end of last year. Moat said prescribers totaled about 5,450, up about 450 from the prior quarter.
Spending guidance for the fourth quarter
Kiniksa expects 2026 research and development spending of $160 million to $170 million, including significant fourth-quarter pre-commercial manufacturing costs for KPL-387. Selling and administrative spending is guided at $270 million to $280 million, covering added fourth-quarter staff and promotion.
Asked about deals, Patel said the company looks at business-development opportunities but the bar is "exceedingly high."
Kiniksa's next stated milestone is the KPL-1161 first-in-human trial, which it expects to start by the end of 2026.
Sources
- Kiniksa Pharma Shares Gain on Higher 3Q Profit, Revenue — MarketWatch
- Kiniksa Pharmaceuticals International, plc GAAP EPS of $0.56 beats by $0.21, revenue of $286M | Seeking Alpha — seekingalpha.com
- Kiniksa Pharmaceuticals Reports Third Quarter 2026 — globenewswire.com
