Kiniksa Pharmaceuticals International, plc Stock Price, News & Analysis

Kiniksa Pharmaceuticals has launched a Named Patient Program for its drug ARCALYST (rilonacept) to enhance access for patients with recurrent pericarditis, CAPS, and DIRA in countries where the drug is not commercially available. This initiative, in partnership with WEP Clinical, aims to support the treatment of patients facing rare autoinflammatory diseases. CEO Sanj K. Patel expressed commitment to addressing the needs of these patients. ARCALYST is FDA-approved and has received several designations for treating recurrent pericarditis, indicating its potential importance in managing these conditions.

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.