Kiniksa Pharmaceuticals International, plc - KNSA STOCK NEWS

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.

Kiniksa Pharmaceuticals announced the successful results of its Phase 2a clinical trial for vixarelimab in treating prurigo nodularis, presenting at the EADV Virtual Congress. The trial met its primary endpoint with a statistically significant reduction in itch severity, showing a 50.6% decrease in weekly-average WI-NRS at Week 8 versus 29.4% in placebo. The company plans to initiate a dose-ranging Phase 2b trial in Q4 2020. Vixarelimab is a fully-human monoclonal antibody targeting OSMRβ, aimed at addressing an unmet medical need in prurigo nodularis.

Kiniksa Pharmaceuticals has announced results from a Phase 2 clinical trial of mavrilimumab for treating giant cell arteritis (GCA). The trial achieved statistical significance in both primary and secondary efficacy endpoints, showing a 62% lower risk of flare and 33.3 percentage points higher sustained remission rate in mavrilimumab recipients compared to placebo. No drug-related serious adverse events were reported. The FDA granted Orphan Drug designation for mavrilimumab, and the company plans to present these findings at the ACR Convergence on November 9, 2020.

Kiniksa Pharmaceuticals announced positive results from the Phase 2 trial of mavrilimumab for treating giant cell arteritis (GCA). Both primary and secondary efficacy endpoints were statistically significant, indicating mavrilimumab may provide a viable treatment option. The trial involved 70 patients aged 50-85, with mavrilimumab showing a 62% lower risk of flare compared to placebo. The safety profile was favorable, with no serious drug-related adverse events noted. The company anticipates further discussions with the FDA to guide next steps in the development program.