Kiniksa is a biopharmaceutical company with an experienced team that has advanced multiple product candidates in parallel that focus on a range of debilitating diseases with significant unmet medical need. We continue to explore expanding our pipeline in order to develop life-changing medicines for patients who need it most.
Relentless and determined – we put patients at the center of everything we do
Product candidates across various stages of development
Target unmet needs and underserved conditions to deliver life-changing treatment
Furthering our understanding of these therapies through research and development
Broad applications across multiple therapeutic categories
Lead Director
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Director
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Chairman & CEO
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Director
FDA accepted the supplemental Biologics License Application (sBLA) for rilonacept in recurrent pericarditis with priority review
FDA grants Breakthrough Therapy designation to vixarelimab for pruritus associated with prurigo nodularis
Announced positive data from Phase 2 trial of mavrilimumab in giant cell arteritis
FDA grants Orphan Drug designation for mavrilimumab for giant cell arteritis
FDA grants Orphan Drug designation for rilonacept for pericarditis
Announced that RHAPSODY, a pivotal Phase 3 trial of rilonacept in recurrent pericarditis, met its primary and all major secondary efficacy endpoints
Announced that 14-day and 28-day data from a treatment protocol of mavrilimumab in severe COVID-19 pneumonia and hyperinflammation in Italy showed earlier and improved clinical outcomes compares to matched contemporaneous controls
Raised ~$80M in gross proceeds from a follow-on public offering and concurrent private placement
Announced that the Phase 2a clinical trial of vixarelimab in prurigo nodularis met its primary efficacy endpoint
Announced early evidence of treatment response with mavrilimumab in 6 patients with severe COVID-19 pneumonia and hyperinflammation
FDA grants Breakthrough Therapy designation for rilonacept for recurrent pericarditis and final Phase 2 clinical data presented at the American Heart Association 2019 Scientific Sessions.
Initiated a first-in-human study with antigen challenge TDAR for KPL-404
Presented rilonacept interim Phase 2 clinical data poster at the American College of Cardiology 68th Annual Scientific Session and raised $88M in gross proceeds from a follow-up public offering and concurrent private placement
Announced interim Phase 2 results and initiation of pivotal Phase 3 trial for rilonacept; FDA accepted investigational new drug application for mavrilimumab and Kiniksa initiated a global Phase 2 clinical trial for giant cell arteritis
Presented KPL-716 clinical data at the 27th European Academy of Dermatology and Venereology supporting advancement into chronic pruritic diseases
Raised $170.7M in gross proceeds from IPO
Presented initial proof-of-concept data for rilonacept in recurrent pericarditis
Raised $200M in Series C capital from new and existing investors and completed dosing in the single ascending dose portion of Phase 1a/1b
Initiated an open-label lead-in study to a planned Phase 3 pivotal trial for KPL-914 in a rare cardiovascular inflammatory disease and acquired the rights to KPL-301
Acquired the rights to KPL-914 and received an exclusive option to acquire KPL-404
Raised $40M in Series B capital from new and existing investors and began enrollment in a Phase 1b study in patients with cutaneous inflammatory disease with KPL-716
Acquired the worldwide rights to our first program (KPL-716) and initiated IND-enabling activities
Raised $80M in committed Series A capital to focus on rapidly bringing therapies to patients who have unmet need
Kiniksa is founded in Hamilton, Bermuda, with its US subsidiary headquarters in Massachusetts