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Kiniksa Reports Third Quarter 2020 Financial Results and Highlights Recent Pipeline and Corporate Activity
Rilonacept commercial launch in recurrent pericarditis anticipated in 1H 2021, if approved by the FDAMavrilimumab Phase 2 trial in GCA achieved primary and
About this update from Kiniksa Pharmaceuticals International, Plc
[{"type":"text","content":"Rilonacept commercial launch in recurrent pericarditis anticipated in 1H 2021, if approved by the FDAMavrilimumab Phase 2 trial in GCA achieved primary and secondary efficacy endpoints with statistical significanceAll cohorts have been dosed in the KPL-404 (anti-CD40) Phase 1 studyCash reserves of approximately $364 million expected to fund current operating plan into 2023 HAMILTON, Bermuda, Nov. 05, 2020 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company with a pipeline of assets designed to modulate immunological pathways across a spectrum of diseases, today reported third quarter 2020 financial results and highlighted recent pipeline and corporate activity.\n “Kiniksa continues to execute across its pipeline,” said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. “We are preparing for the commercial launch of rilonacept in recurrent pericarditis in the first half of 2021, if approved by the FDA. The primary and secondary efficacy endpoints of the mavrilimumab Phase 2 trial in giant cell arteritis achieved statistical significance, further demonstrating the potential broad utility of the molecule. Additionally, all cohorts have been dosed in the Phase 1 study of KPL-404, our anti-CD40 program, and we expect data from the first cohorts this quarter.” Pipeline ActivityRilonacept (IL-1α and IL-1β cytokine trap) Kiniksa anticipates the commercial launch of rilonacept in recurrent pericarditis in the first half of 2021, if approved by the U.S. Food and Drug Administration (FDA) assuming priority review.- If rilonacept is approved for recurrent pericarditis by the FDA, Kiniksa will commence the sales and distribution of rilonacept for the approved indications in the United States and evenly split profits on sales with Regeneron Pharmaceuticals, Inc. (Regeneron).-Kiniksa is obligated to pay regulatory milestones to Regeneron of up to an aggregate of $27.5 million through the potential approval of rilonacept in recurrent pericarditis.Kiniksa expects data from RHAPSODY, the pivotal Phase 3 clinical trial of rilonacept in recurrent pericarditis, to be presented at the late-breaking science session during the American Heart Association (AHA) Scientific Sessions 2020.- Dr. Allan Klein, MD, of Cleveland Clinic and co-principal investigator for RHAPSODY, will...
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