Kiniksa Reports Fourth Quarter and Full-Year 2020 Financial Results and Corporate and Pipeline Activity

About this update from Kiniksa Pharmaceuticals International, Plc

[{"type":"text","content":"- Strong execution across pipeline of immune-modulating assets throughout 2020 enables multiple milestones in 2021 -- Rilonacept in recurrent pericarditis granted priority review, with PDUFA goal date of March 21, 2021 -- Clinical data expected in 1H 2021 from KPL-404 (anti-CD40) Phase 1 clinical trial and mavrilimumab Phase 2 clinical trial in severe COVID-19 -- Year-end 2020 cash reserves of approximately $323 million - HAMILTON, Bermuda, Feb. 23, 2021 (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 fourth quarter and full-year 2020 financial results and corporate and pipeline activity. “Kiniksa delivered outstanding performance in 2020, with encouraging clinical data across our pipeline as well as Breakthrough Therapy designation or Orphan Drug designation for rilonacept, mavrilimumab and vixarelimab,” said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. “Building on this momentum, we expect to launch rilonacept in recurrent pericarditis, pending FDA approval, in the first half of 2021. We also anticipate final Phase 1 data for KPL-404, our anti-CD40 program, in which data generated to-date support the best-in-class potential of this molecule and the opportunity for its evaluation in multiple devastating autoimmune diseases. Further, we expect data from the fully-enrolled mavrilimumab Phase 2 clinical trial in severe COVID-19 in the first half of this year. With these significant advances, it is important to highlight we are well capitalized with cash reserves of approximately $323 million.” Pipeline ActivityRilonacept (IL-1α and IL-1β cytokine trap) Kiniksa is preparing for 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). The FDA accepted the supplemental Biologics License Application (sBLA) for rilonacept in recurrent pericarditis with priority review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 21, 2021.Upon approval in recurrent pericarditis, Kiniksa will commence sales and distribution of rilonacept for the approved indications in the United States, including cryopyrin-associated periodic syndrom...

More updates from Kiniksa Pharmaceuticals International, Plc