Welcome to our dedicated page for Kiniksa Pharmaceuticals International, plc news (Ticker: KNSA), a resource for investors and traders seeking the latest updates and insights on Kiniksa Pharmaceuticals International, plc stock.
Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) is a commercial-stage biopharmaceutical company dedicated to discovering, acquiring, developing, and commercializing therapeutic medicines for patients with debilitating diseases that have significant unmet medical needs. Headquartered in Hamilton, Bermuda, Kiniksa is at the forefront of developing immune-modulating assets aimed at addressing a spectrum of cardiovascular and autoimmune conditions.
The company’s clinical-stage product candidates include:
- ARCALYST (rilonacept): The first and only FDA-approved therapy for recurrent pericarditis, a debilitating inflammatory cardiovascular disease. ARCALYST is also approved for cryopyrin-associated periodic syndromes (CAPS) and deficiency of IL-1 receptor antagonist (DIRA).
- Mavrilimumab: An investigational monoclonal antibody targeting the GM-CSF receptor, currently being evaluated for its potential in treating giant cell arteritis and other rare cardiovascular diseases.
- Vixarelimab: An investigational monoclonal antibody inhibitor of signaling through OSMRβ.
- Abiprubart (formerly KPL-404): A humanized monoclonal antibody designed to inhibit the CD40-CD154 interaction, aimed at treating autoimmune diseases such as rheumatoid arthritis and Sjogren’s Disease.
Kiniksa’s robust pipeline is supported by significant financial strength. The company reported strong revenue growth with ARCALYST, achieving net product revenue of approximately $233.1 million in 2023, a 90% year-over-year increase. This financial performance provides a solid foundation for future investments in both commercial and clinical development projects.
Recent news highlights Kiniksa’s progress:
- In July 2023, Kiniksa announced plans to raise its 2023 ARCALYST sales guidance to between $220 million and $230 million, citing increased prescriber adoption and patient enrollments.
- In October 2023, the company reported third-quarter financial results and the completion of enrollment in the third cohort of the Phase 2 trial of KPL-404 in rheumatoid arthritis, with data expected in the first quarter of 2024.
- In February 2024, Kiniksa announced its plans to initiate a Phase 2b trial of abiprubart in Sjogren’s Disease in the second half of 2024, supported by robust ARCALYST revenue growth and a strong cash position.
For more information about Kiniksa and its pipeline, visit www.kiniksa.com.
Kiniksa Pharmaceuticals reported Q3 2021 net revenue of $12.1 million from ARCALYST, with over 200 physicians prescribing the treatment for recurrent pericarditis. The company anticipates Phase 3 trial data for mavrilimumab in COVID-19-related ARDS in Q1 2022 and Phase 2b data for vixarelimab in prurigo nodularis in 2H 2022. Kiniksa forecasts Q4 2021 ARCALYST net revenue between $16.0 million and $17.0 million and projects sufficient cash to fund operations into 2023.
Kiniksa Pharmaceuticals (KNSA) will host a conference call on November 1, 2021, at 8:30 a.m. ET to discuss its Q3 2021 financial results and recent developments. Interested parties can access the live webcast through the company's website, with a replay available within 48 hours. Kiniksa focuses on developing therapeutic medicines for debilitating diseases with unmet needs, featuring assets like ARCALYST, mavrilimumab, vixarelimab, and KPL-404. These therapies target immunological pathways and aim to differentiate within their respective markets.
Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) announced its participation in the 2021 Cantor Fitzgerald Virtual Global Healthcare Conference. The event will take place on Tuesday, September 28, 2021, at 10:40 a.m. Eastern Time. Interested parties can access the live webcast via the Investors & Media section of Kiniksa's website, with a replay available approximately 48 hours post-event. Kiniksa focuses on developing therapeutic medicines for serious diseases, with its portfolio including ARCALYST®, mavrilimumab, vixarelimab, and KPL-404, targeting significant unmet medical needs.
Kiniksa Pharmaceuticals has launched a Named Patient Program for its drug ARCALYST (rilonacept) to enhance access for patients with recurrent pericarditis, CAPS, and DIRA in countries where the drug is not commercially available. This initiative, in partnership with WEP Clinical, aims to support the treatment of patients facing rare autoinflammatory diseases. CEO Sanj K. Patel expressed commitment to addressing the needs of these patients. ARCALYST is FDA-approved and has received several designations for treating recurrent pericarditis, indicating its potential importance in managing these conditions.
Kiniksa Pharmaceuticals reported Q2 2021 net revenue of $7.7 million from ARCALYST sales, with over 100 prescribing physicians. The company anticipates ARCALYST revenue to reach between $9.0 million and $10.0 million in Q3 2021. Progress is being made in clinical trials, including Phase 3 data for mavrilimumab in COVID-19-related ARDS expected in Q1 2022. KPL-404 Phase 2 trial initiation is planned for Q4 2021. The net loss for the quarter was $41.6 million, up from $37.5 million in Q2 2020, with total operating expenses of $48.3 million.
Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) will present at the 2021 Wedbush PacGrow Healthcare Conference on August 10, 2021, at 2:55 p.m. ET. A live webcast of the presentation will be available on Kiniksa's website, with a replay accessible for 14 days post-conference. The company focuses on developing therapeutic medicines for patients with significant unmet medical needs, including its portfolio of assets such as ARCALYST®, mavrilimumab, vixarelimab, and KPL-404, targeting various debilitating diseases.
Kiniksa Pharmaceuticals (KNSA) is set to hold a conference call on August 3, 2021, at 8:30 a.m. ET to discuss its second quarter 2021 financial results and recent corporate activities. The event will be accessible via a live webcast on the company’s website, with a replay available for 14 days post-event. Kiniksa focuses on developing therapeutic medicines for diseases with significant unmet needs, leveraging a diverse portfolio including ARCALYST®, mavrilimumab, vixarelimab, and KPL-404.
Kiniksa Pharmaceuticals (KNSA) has announced the issuance of U.S. Patent No. 11,026,997, covering methods for using ARCALYST® (rilonacept) in treating recurrent pericarditis, which will expire on March 11, 2039. This patent strengthens Kiniksa's proprietary position and extends protection beyond orphan drug exclusivity. CEO Sanj K. Patel highlighted the upcoming full quarter sales report for ARCALYST in Q2. Recurrent pericarditis affects around 40,000 U.S. patients annually, with significant quality of life impacts.
Kiniksa Pharmaceuticals has defined a regulatory path for the Phase 3 clinical development of mavrilimumab, targeting multiple indications including COVID-19-related ARDS, giant cell arteritis, and rheumatoid arthritis. Mavrilimumab's ongoing Phase 3 trial in COVID-19-related ARDS aims for rapid registration, with results expected in Q1 2022. The trial will enroll approximately 600 patients, progressing from promising Phase 2 results. Kiniksa maintains a solid cash reserve of $264 million, supporting operations into 2023.
Kiniksa Pharmaceuticals (Nasdaq: KNSA) announced its participation in the Goldman Sachs 42nd Annual Global Healthcare Conference, scheduled for June 8, 2021, at 9:40 a.m. Eastern Time. The presentation will be available via a live webcast on the company's website, with a replay accessible for 14 days post-event. Kiniksa focuses on developing therapeutic medicines for patients with significant unmet medical needs, with products including ARCALYST (rilonacept) and others designed to target immunological pathways.
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