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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 has announced a public offering of 5,952,381 Class A common shares at $21.00 each, aiming for gross proceeds of approximately $155 million, including a concurrent private placement of 1,428,572 shares. The offering is set to close on July 24, 2020. Proceeds will support the development and commercialization of its product candidates, alongside working capital needs. Joint book-running managers for the offering include Goldman Sachs, BofA Securities, and J.P. Morgan.
Kiniksa Pharmaceuticals (Nasdaq: KNSA) announced a public offering of $100 million in Class A common shares, with an option for underwriters to purchase an additional $15 million. The proceeds will be used to advance product development and commercialization, as well as for general corporate purposes. Goldman Sachs, BofA Securities, and J.P. Morgan are acting as joint book-running managers. The registration statement for this offering was declared effective on June 10, 2019. Investors should review the prospectus for more information.
Kiniksa Pharmaceuticals, Ltd. (NASDAQ: KNSA) announced that the FDA granted Orphan Drug designation for rilonacept to treat pericarditis, including recurrent forms. This treatment, which is injected weekly, blocks two signaling proteins, IL-1α and IL-1β. The company plans to submit a supplemental Biologics License Application (sBLA) for recurrent pericarditis later in 2020, following positive Phase 3 trial results from RHAPSODY, which met all primary and secondary endpoints. The Orphan Drug status offers financial incentives and exclusivity for seven years upon approval.
Kiniksa Pharmaceuticals (KNSA) reported positive results from RHAPSODY, a pivotal Phase 3 trial of rilonacept for recurrent pericarditis. The trial met its primary and all major secondary efficacy endpoints, showing a 96% reduction in recurrence risk (Hazard Ratio = 0.04, p<0.0001). The safety profile aligns with FDA-approved uses for CAPS. Kiniksa plans to submit a Supplemental Biologics License Application (sBLA) later this year. Rilonacept is positioned to potentially become the first FDA-approved treatment for recurrent pericarditis, addressing significant unmet medical needs.
Kiniksa Pharmaceuticals (KNSA) announced a presentation at the European E-Congress of Rheumatology (EULAR) 2020 on June 3, 2020, showcasing data on mavrilimumab, an investigational monoclonal antibody for severe COVID-19 pneumonia and hyperinflammation. The oral presentation will detail outcomes from an open-label treatment protocol conducted in Italy, while additional preclinical data on the GM-CSF pathway in giant cell arteritis will be presented on June 5. Mavrilimumab has previously met its primary efficacy and safety endpoints in Phase 2b studies for rheumatoid arthritis.
Kiniksa Pharmaceuticals (KNSA) has closed a public offering of 2,760,000 Class A common shares at $18.25 each, raising approximately $80 million in gross proceeds. This includes the complete exercise of the underwriters' option to purchase additional shares. The offering was managed by Goldman Sachs, J.P. Morgan, and BofA Securities, with co-management by Wedbush Securities and JMP Securities. Kiniksa focuses on developing therapeutic medicines for serious diseases, with a clinical pipeline including rilonacept, mavrilimumab, vixarelimab, and KPL-404 targeting immunological pathways.
Kiniksa Pharmaceuticals (Nasdaq: KNSA) has announced a public offering of 2,400,000 Class A common shares, priced at $18.25 each, alongside a private placement of 1,600,000 shares. The total expected gross proceeds from both offerings is approximately $73 million. The funds will be used to advance clinical development and for general corporate purposes. The public offering is set to close on May 18, 2020, subject to standard conditions. The underwriters have a 30-day option to purchase an additional 360,000 shares.
Kiniksa Pharmaceuticals (Nasdaq: KNSA) announced a public offering of 1,800,000 Class A common shares, with an additional 270,000 shares available to underwriters. The net proceeds will support the clinical development of its product candidates, fund R&D activities, and cover general corporate purposes. Goldman Sachs, J.P. Morgan, and BofA Securities are managing the offering. Kiniksa emphasizes that the offering's details are included in the SEC registration statement, which should be reviewed before investing.
The press release from Kiniksa Pharmaceuticals, Ltd. highlights positive clinical results from two investigational treatments: mavrilimumab and vixarelimab. Mavrilimumab demonstrated improved outcomes in severe COVID-19 pneumonia patients, with 85% achieving clinical improvement by day 14, significantly outperforming the control group. Vixarelimab showed promising efficacy in chronic pruritus diseases, particularly plaque psoriasis, achieving a statistically significant reduction in itch severity. Kiniksa plans further development for both drugs, including potential registrational studies for mavrilimumab.