Kiniksa Pharmaceuticals International Plc is a commercial-stage biopharmaceutical company. It engages in discovering, acquiring, developing, and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. The company was founded on April 9, 2024 and is headquartered in London, United Kingdom.
相关临床试验
13
9 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
进行中（未招募）
9
69.2%
已完成
4
30.8%
暂无批准数据
- ARCALYST (rilonacept) generated $243.6 million in Q2 2026 net product revenue, representing approximately 55% year-over-year growth, prompting Kiniksa to raise full-year 2026 guidance to $980–$995 million. - KPL-387 Phase 2 data showed rapid and sustained reductions in pain and inflammation with once-monthly 300 mg subcutaneous dosing, with median time to treatment response of 4.0 days. - The pivotal Phase 3 PASTORALE trial for KPL-387 is now enrolling and dosing patients, with potential commercialization expected in the 2028/2029 timeframe. - Kiniksa also announced KPL-1161, an Fc-modified IL-1 receptor antagonist targeting quarterly dosing, with a Phase 1 trial expected to begin by the end of 2026.
- Kiniksa Pharmaceuticals reported Q1 2026 Arcalyst net revenue of over $214 million, nearly doubling from $138 million in the same period last year. - GAAP net income more than doubled to $22.6 million ($0.27 per share), beating consensus analyst estimates for both revenue and earnings. - Management raised full-year 2026 Arcalyst net revenue guidance to $930–$945 million, up from the prior range of $900–$920 million. - The company is advancing next-generation IL-1 pipeline candidates KPL-387 (phase II/III) and KPL-1161 (preclinical) to extend its leadership in cardiovascular and autoinflammatory diseases.
- The U.S. FDA has granted Orphan Drug Designation to Kiniksa Pharmaceuticals' investigational monoclonal antibody KPL-387 for treating pericarditis, including recurrent pericarditis. - KPL-387 is designed as a convenient monthly self-injection therapy that binds human interleukin-1 receptor 1, inhibiting IL-1α and IL-1β cytokine signaling activity. - Data from the Phase 2 dose-focusing portion of KPL-387's Phase 2/3 recurrent pericarditis trial are expected in the second half of 2026. - This regulatory milestone represents progress in Kiniksa's cardiovascular pipeline diversification, though the company's near-term growth remains dependent on ARCALYST revenue performance.
- AbbVie's Rinvoq (upadacitinib) received FDA approval in April 2025 as the first oral JAK inhibitor for adult giant cell arteritis patients, based on Phase III SELECT-GCA trial results showing 46.4% sustained remission versus 29% placebo. - Novartis' Cosentyx (secukinumab) failed to meet its primary endpoint in the Phase III GCAptAIN trial in July 2025, showing no significant improvement in sustained remission at 52 weeks compared to placebo. - Over six pharmaceutical companies are actively developing more than six therapeutic candidates for giant cell arteritis, the most common vasculitis in individuals over 50 that can cause permanent vision loss without treatment. - The expanding pipeline includes monoclonal antibodies and small molecule inhibitors targeting various inflammatory pathways, reflecting growing innovation in addressing this critical autoimmune condition.
- Kiniksa Pharmaceuticals announced the trial design for its Phase 2/3 clinical study of KPL-387, a monoclonal antibody targeting IL-1R1, in recurrent pericarditis patients. - The trial will enroll up to 165 participants across dose-focusing and pivotal portions, with initiation planned for mid-2025 and Phase 2 data expected in the second half of 2026. - KPL-387 offers a potential monthly subcutaneous dosing profile, which could expand treatment options for recurrent pericarditis patients currently facing limited therapeutic alternatives.
- ARCALYST achieved remarkable growth with $417 million in 2024 net product revenue, representing a 79% year-over-year increase, with projected 2025 revenue between $560-580 million. - Kiniksa plans to initiate Phase 2/3 clinical trial of KPL-387 for recurrent pericarditis in mid-2025, offering potential monthly subcutaneous dosing option for patients. - Company announces strategic focus on cardiovascular indications while discontinuing abiprubart development in Sjögren's Disease, maintaining positive cash flow expectations.
• The urticaria treatment landscape is evolving, with over 20 companies developing more than 25 novel therapies to address unmet patient needs. • Regeneron and Sanofi's Dupixent demonstrated positive Phase III results for chronic spontaneous urticaria, showing promise for biologic-naive patients. • Evommune initiated a Phase II trial of EVO756 for chronic inducible urticaria, while Celldex Therapeutics reported positive Phase II data for barzolvolimab in chronic spontaneous urticaria. • Emerging therapies target various mechanisms, including IgE, mast cells, and kinases, offering diverse approaches to urticaria management.
