Kiniksa Pharmaceuticals International, plc - KNSA STOCK NEWS

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.

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.