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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 announced positive results from the Phase 2 trial of mavrilimumab for treating giant cell arteritis (GCA). Both primary and secondary efficacy endpoints were statistically significant, indicating mavrilimumab may provide a viable treatment option. The trial involved 70 patients aged 50-85, with mavrilimumab showing a 62% lower risk of flare compared to placebo. The safety profile was favorable, with no serious drug-related adverse events noted. The company anticipates further discussions with the FDA to guide next steps in the development program.
Kiniksa Pharmaceuticals (KNSA) announced its virtual Rilonacept Analyst Day scheduled for September 29, 2020. The event will include discussions on the market potential for rilonacept in treating recurrent pericarditis and the company's commercial launch strategy. Key presentations will feature insights from Kiniksa's management and Dr. Paul Cremer from Cleveland Clinic. Notably, there are currently no FDA-approved treatments for recurrent pericarditis, highlighting a significant market opportunity for rilonacept, which has received Breakthrough Therapy designation from the FDA.
Kiniksa (Nasdaq: KNSA) will host a virtual Rilonacept Analyst Day on September 28, 2020, focusing on the market opportunity for rilonacept in recurrent pericarditis. The event will include insights from Kiniksa's management and guest speaker Paul Cremer from the Cleveland Clinic. Rilonacept, originally developed by Regeneron, is FDA-approved for Cryopyrin-Associated Periodic Syndromes but aims to address recurrent pericarditis, a condition with no current FDA-approved treatments. Kiniksa plans to submit a supplemental Biologic License Application for rilonacept later this year.
Kiniksa Pharmaceuticals (Nasdaq: KNSA) will present at the Morgan Stanley 18th Annual Global Healthcare Conference on September 16, 2020, at 2:00 p.m. ET. A live webcast of the presentation will be available on Kiniksa's website. A replay will be accessible for 14 days post-conference. Kiniksa focuses on developing therapeutic medicines for debilitating diseases and has several clinical-stage product candidates, including rilonacept and mavrilimumab, which aim to address unmet medical needs through innovative approaches.
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.
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