Kiniksa: Phase 3 Rilonacept Study Meets Key Endpoints in Recurrent Pericarditis
29 June 2020 - 10:15PM
Dow Jones News
By Colin Kellaher
Kiniksa Pharmaceuticals Ltd. on Monday said a pivotal phase 3
study of rilonacept in recurrent pericarditis met its primary and
major secondary efficacy endpoints.
The Hamilton, Bermuda, biopharmaceutical company said rilonacept
improved clinically meaningful outcomes associated with the unmet
medical need in the autoinflammatory disease.
Kiniksa said it expects to submit a supplemental biologics
license application to the U.S. Food and Drug Administration later
this year. The FDA last year granted breakthrough-therapy
designation to rilonacept for the treatment of recurrent
pericarditis.
Rilonacept, which was discovered and developed by Regeneron
Pharmaceuticals Inc., is approved by the FDA under the brand name
Arcalyst for the treatment of cryopyrin-associated periodic
syndromes. Under a 2017 licensing agreement with Regeneron, the
biologic license application for that indication will transfer to
Kiniksa.
If the FDA approves the drug in recurrent pericarditis, Kiniksa
would assume the sales and distribution of rilonacept for approved
indications in the U.S. and would evenly split profits on sales
with Regeneron.
Trading in shares of Kiniksa was halted premarket on Monday.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
June 29, 2020 08:00 ET (12:00 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
Regeneron Pharmaceuticals (NASDAQ:REGN)
Historical Stock Chart
From Jun 2024 to Jul 2024
Regeneron Pharmaceuticals (NASDAQ:REGN)
Historical Stock Chart
From Jul 2023 to Jul 2024