Kiniksa Pharmaceuticals International, plc - KNSA STOCK NEWS

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.

Kiniksa Pharmaceuticals (Nasdaq: KNSA) announced the publication of pivotal Phase 3 trial data for rilonacept in recurrent pericarditis in The New England Journal of Medicine. The trial, RHAPSODY, demonstrated a 96% reduction in risk of recurrent events and significant decreases in pain and inflammation after the first dose. Rilonacept was well-tolerated, with no drug-related serious adverse events reported. These findings, presented at the AHA Scientific Sessions 2020, may indicate a significant advancement in treating recurrent pericarditis, a condition with no FDA-approved therapies.

Kiniksa (Nasdaq: KNSA) announced that the FDA has granted Breakthrough Therapy designation to vixarelimab for treating pruritus associated with prurigo nodularis, a chronic skin condition. This designation is based on encouraging results from the Phase 2a clinical trial, which showed a statistically significant reduction in itch severity at Week 8. Kiniksa plans to initiate a Phase 2b clinical trial assessing various dosing regimens for vixarelimab by year-end.

Kiniksa Pharmaceuticals (Nasdaq: KNSA) announced the successful outcomes of its Phase 2 clinical trial for mavrilimumab in treating giant cell arteritis (GCA). The trial, presented at the ACR Convergence 2020, demonstrated significant reductions in flare risk and enhancements in sustained remission among patients. Mavrilimumab showed statistically significant results across both primary and secondary endpoints, with no serious drug-related adverse events reported. The company plans to continue discussions with the FDA regarding further development, having received Orphan Drug designation for GCA.

Kiniksa Pharmaceuticals (KNSA) reported a net loss of $43.8 million for Q3 2020, up from $27.1 million in Q3 2019. Total operating expenses rose to $43.2 million compared to $30.4 million in the previous year. The company has cash reserves of approximately $364 million, which is expected to fund operations into 2023. Key pipeline updates include the anticipated launch of rilonacept for recurrent pericarditis in H1 2021, pending FDA approval, and positive Phase 2 results for mavrilimumab in giant cell arteritis, achieving statistical significance in primary and secondary endpoints.