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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 a transformative first quarter 2021, highlighted by the FDA approval of ARCALYST for recurrent pericarditis, the first approved therapy for this condition. The commercial launch began in April 2021. The company also reported positive data for mavrilimumab in severe COVID-19 pneumonia and plans to initiate a Phase 2 trial for KPL-404 in rheumatoid arthritis. However, Q1 2021 net loss increased to $49.5 million from $26.4 million a year ago. As of March 31, 2021, Kiniksa holds $264 million in cash, expected to support operations into 2023.
Kiniksa Pharmaceuticals (KNSA) announced positive final data from its Phase 1 trial of KPL-404, a monoclonal antibody targeting the CD40-CD154 pathway. The 10 mg/kg IV dose showed full receptor occupancy through Day 71 and complete suppression of the T-cell dependent antibody response (TDAR) after KLH challenge for at least 57 days. The 5 mg/kg SC dose achieved full receptor occupancy through Day 43. Kiniksa plans to initiate a Phase 2 proof-of-concept trial in rheumatoid arthritis patients in the second half of 2021, aiming to explore chronic dosing and potential efficacy in various autoimmune diseases.
Kiniksa Pharmaceuticals (KNSA) announced that the Phase 2 trial of mavrilimumab in non-mechanically-ventilated patients with severe COVID-19 pneumonia achieved its primary efficacy endpoint. The trial showed that patients treated with mavrilimumab had a 12.3 percentage point higher survival rate without mechanical ventilation at Day 29 compared to placebo (86.7% vs. 74.4%). Additionally, there was a 65% reduction in the risk of mechanical ventilation or death (p=0.0175) and a 61% reduction in death risk (p=0.0726). The company is in discussions with regulatory agencies to expedite mavrilimumab's availability.
Kiniksa Pharmaceuticals announced the commercial availability of ARCALYST (rilonacept), the first FDA-approved treatment for recurrent pericarditis, effective March 18, 2021. This therapy is available for patients aged 12 and older and aims to reduce recurrence risk. Kiniksa is committed to patient support through its Kiniksa One Connect™ program, offering access and affordability solutions. The drug is distributed via specialty pharmacies across the U.S. Kiniksa will profit-share with Regeneron under the licensing agreement, which includes support for additional indications.
Kiniksa Pharmaceuticals has announced that the FDA approved ARCALYST (rilonacept), the first and only therapy for recurrent pericarditis, which impacts approximately 40,000 patients annually in the U.S. The approval is based on the promising results from the pivotal RHAPSODY Phase 3 trial, which demonstrated a 96% reduction in the risk of pericarditis recurrence. The commercial launch is set for April 2021. Kiniksa will also support patients through the Kiniksa One Connect™ program for enhanced access and affordability.
Kiniksa Pharmaceuticals has launched the RESONANCE registry to better understand the management of recurrent pericarditis, a debilitating cardiovascular disease. The registry aims to collect uniform data from physicians and patients, enhancing insights into treatment practices. Supported by expert physician-researchers and patient advocates, RESONANCE will gather patient-reported outcomes and observational data. Approximately 20 sites in the US will participate, starting in 2021, addressing the unmet medical needs of this underserved condition.
Kiniksa Pharmaceuticals reported a net loss of $53.7 million in Q4 2020, compared to $31.8 million in Q4 2019, and a net loss of $161.4 million for the full year. Total operating expenses fell to $157.4 million for 2020 versus $170.0 million in 2019. The company anticipates launching rilonacept in recurrent pericarditis in 1H 2021, pending FDA approval. With approximately $323 million in cash reserves, Kiniksa is well-positioned to fund operations into 2023. Upcoming clinical data from KPL-404 and mavrilimumab is expected in 1H 2021.
Kiniksa Pharmaceuticals (KNSA) has outlined its corporate priorities and milestones for 2021, highlighting the PDUFA goal date of March 21 for rilonacept in recurrent pericarditis. If approved, a commercial launch is anticipated in the first half of 2021. Data from the Phase 2 portion of the mavrilimumab trial for severe COVID-19 pneumonia and hyperinflammation is expected in 1H 2021, alongside final Phase 1 data for KPL-404. The company ended 2020 with around $323 million in cash reserves, projected to fund operations into 2023, indicating financial stability.
Kiniksa Pharmaceuticals (Nasdaq: KNSA) will present at the 39th Annual J.P. Morgan Healthcare Conference on January 11, 2021, at 4:30 p.m. ET. A live webcast of the presentation can be accessed via the company’s Investors & Media section at kiniksa.com, with a replay available for 14 days post-conference.
Kiniksa focuses on developing therapeutic medicines for diseases with significant unmet needs, featuring pipeline candidates like rilonacept and mavrilimumab.
Kiniksa Pharmaceuticals (Nasdaq: KNSA) announced early data from a placebo-controlled study of mavrilimumab for severe COVID-19 pneumonia, revealing trends of reduced mortality and shorter duration of mechanical ventilation. Notably, 57.1% of mavrilimumab patients were alive and off supplemental oxygen by Day 14, compared to 47.4% in the placebo group. The Phase 2 results are consistent with earlier findings and support further evaluation of mavrilimumab. The company expects additional data from the ongoing Phase 2/3 trial by mid-2021.
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