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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 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.
Kiniksa Pharmaceuticals has initiated dosing in a Phase 2b clinical trial of vixarelimab for prurigo nodularis, a chronic inflammatory skin condition. This investigational fully-human monoclonal antibody targets the OSMRβ receptor and aims to alleviate pruritus and skin nodules. The trial will enroll around 180 patients and includes various dosing regimens. The FDA granted Breakthrough Therapy designation in 2020, based on promising results from a prior Phase 2a trial, where significant improvements were noted in patient outcomes.
Kiniksa Pharmaceuticals (KNSA) announced preliminary data from its Phase 1 clinical trial of KPL-404, a monoclonal antibody aimed at autoimmune diseases. The trial showed full receptor occupancy at 3 mg/kg IV through Day 29 and complete suppression of T-cell dependent antibody response. All dose escalations followed protocol with no adverse safety findings. Kiniksa is optimistic about KPL-404's potential for treating diseases such as rheumatoid arthritis and lupus, and anticipates full data release in early 2021.
Kiniksa Pharmaceuticals (KNSA) will present at the Evercore ISI 3rd Annual HealthCONx Conference on December 1, 2020, at 8:50 a.m. ET. A live webcast of the presentation can be accessed on the company's website, with a replay available for 14 days post-conference.
Kiniksa focuses on biopharmaceuticals, developing treatments for diseases with unmet needs. Its pipeline includes rilonacept, mavrilimumab, vixarelimab, and KPL-404, which target immunological pathways and aim to address underserved conditions.
Kiniksa Pharmaceuticals announced FDA acceptance of the supplemental Biologics License Application for rilonacept in treating recurrent pericarditis, with a priority review and a PDUFA goal date of March 21, 2021. This regulatory submission, based on positive Phase 3 RHAPSODY trial data, indicates significant efficacy, aiming to address a critical unmet medical need. Rilonacept, originally developed by Regeneron, blocks IL-1 signaling and could become the first approved treatment for this painful condition. Kiniksa is committed to commercializing rilonacept upon approval.