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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 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.
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.