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LONDON - Kiniksa Pharmaceuticals International, plc (NASDAQ:KNSA), a biopharmaceutical company with a market capitalization of $1.42 billion focused on developing therapies for cardiovascular diseases and other conditions with unmet medical needs, announced plans to initiate a Phase 2/3 clinical trial of KPL-387 for the treatment of recurrent pericarditis, expected to begin in mid-2025.
KPL-387, a monoclonal antibody targeting interleukin-1 receptor 1 (IL-1R1), has shown potential for monthly dosing based on Phase 1 single ascending dose data. The company aims to build on the success of its existing treatment, ARCALYST, which has generated over $800 million since its 2021 launch, contributing to impressive revenue growth of 54.41% in the last twelve months and a healthy gross margin of 61.04%. According to InvestingPro analysis, Kiniksa appears slightly undervalued based on its Fair Value calculations, with 6 additional ProTips available for subscribers.
Kiniksa’s decision to proceed with the Phase 2/3 trial follows interactions with the U.S. Food and Drug Administration (FDA), with Phase 2 results anticipated in the second half of 2026. The company is also developing KPL-1161, another monoclonal antibody with a quarterly dosing profile, and has decided to discontinue the development of abiprubart for Sjögren’s Disease.
ARCALYST, Kiniksa’s currently approved drug for recurrent pericarditis, is a subcutaneously injected recombinant fusion protein blocking interleukin-1 signaling. The treatment is also approved for Cryopyrin-Associated Periodic Syndromes (CAPS) and Deficiency of Interleukin-1 Receptor Antagonist (DIRA).
Kiniksa’s focus remains on addressing diseases with significant unmet needs, particularly in the cardiovascular space. The company’s portfolio is built on strong biological rationale or validated mechanisms, aiming to offer differentiated treatment options.
The information in this article is based on a press release statement from Kiniksa Pharmaceuticals International, plc. For comprehensive analysis and detailed financial metrics, access the full Pro Research Report available exclusively on InvestingPro, covering over 1,400 US stocks with expert insights and actionable intelligence.
In other recent news, Kiniksa Pharmaceuticals reported its preliminary financial results for the fiscal year 2024, revealing Arcalyst revenue of $416.4 million. This figure represents a 79% increase from the previous year and surpasses both Goldman Sachs and Visible Alpha’s estimates of $406.8 million and $411.2 million, respectively. Looking ahead, Kiniksa has projected Arcalyst revenue for FY25 to be between $560 million and $580 million, exceeding Goldman Sachs’s forecast of $529 million. These projections highlight Kiniksa’s strong commercial execution, particularly with the Arcalyst launch. Goldman Sachs maintained its Buy rating for Kiniksa, setting a steady price target of $32.00. The analyst noted that consensus estimates have largely adjusted to Kiniksa’s robust performance, with only a slight beat in guidance. Attention may now shift to updates on Kiniksa’s abiprubart program for Sjögren’s disease, which currently lacks an approved FDA therapy. These developments reflect confidence in Kiniksa’s commercial strategy and potential future advancements.
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