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Kiniksa Pharmaceuticals International, plc develops and commercializes novel therapies for diseases with unmet need, with a focus on cardiovascular indications. News about Kiniksa commonly covers ARCALYST (rilonacept), an IL-1α and IL-1β cytokine trap approved by the FDA for recurrent pericarditis and other autoinflammatory indications.
Company updates also address ARCALYST commercial performance, patient-awareness initiatives in recurrent pericarditis, quarterly and annual financial results, and portfolio execution. Additional recurring themes include the KPL-387 recurrent pericarditis program, KPL-1161 IL-1 receptor antagonist development, corporate updates, and healthcare conference presentations.
Kiniksa Pharmaceuticals (KNSA) presented findings at ESC Congress 2020 on the impact of recurrent pericarditis on patients' quality of life. The survey revealed significant physical and mental health burdens, emphasizing the need for effective treatment. Their pivotal Phase 3 trial of rilonacept demonstrated a 96% reduction in pericarditis recurrence risk, leading to plans for an sBLA submission to the FDA. Kiniksa aims to commercialize rilonacept, with existing FDA designations supporting its use in recurrent pericarditis. The company continues to generate evidence on the disease's burden.
Kiniksa Pharmaceuticals (Nasdaq: KNSA) announced its participation at the 2020 Wedbush PacGrow Healthcare Conference, scheduled for August 11, 2020, at 1:10 p.m. Eastern Time. A live webcast of the presentation will be available on the company's website, and a replay will be accessible for 14 days post-conference. Kiniksa focuses on developing therapeutic medicines for patients with unmet medical needs, with clinical-stage candidates targeting various immunological pathways.
Kiniksa Pharmaceuticals (KNSA) reported significant advancements in its pipeline, with the pivotal Phase 3 trial of rilonacept in recurrent pericarditis achieving a 96% risk reduction in event recurrence. The company plans to submit a supplemental Biologics License Application (sBLA) to the FDA this year. A recent capital raise of ~$220 million will extend cash reserves into 2023. Moreover, mavrilimumab is in global trials for COVID-19 pneumonia, and vixarelimab's Phase 2 is set for prurigo nodularis. Despite a net loss of $37.5 million, operating expenses decreased from 2019, indicating financial discipline.
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.