Caliway's CBL-514 Combination Therapy Cleared by U.S. FDA for Phase 2 Trial; Pivotal Phase 3 Trial SUPREME-01 Initiates Enrollment
FDA IND Clearance for CBL-0201WR—Caliway has cleared its Investigational New Drug application for CBL-0201WR, a Phase 2 trial evaluating CBL-514 in combination with tirzepatide. U.S. IRB Approval for Pivotal Phase 3 Trial SUPREME-01 (CBL-0301)—The...
/C O R R E C T I O N -- Akeso, Inc./
In the news release, Akeso's AK157D1 (B7-H3 ADC) Cleared for Phase I Trial in Solid Tumors, Adding a Third Differentiated ADC to Its Pipeline, issued 21-Aug-2026 by Akeso, Inc. over PR Newswire, we are advised by the company that there are some...
Novel Anti-Fibrotic Drug AK3280 Cleared by FDA to Initiate Phase 2 Proof-of-Concept Clinical Trial in IPF
SHANGHAI, Feb. 12, 2026 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for AK3280, a novel anti-fibrotic...
Akeso's IL-4Rα/ST2 Bispecific Antibody Cleared for Seven Phase II Studies in China Spanning Respiratory and Autoimmune Indications
HONG KONG, Feb. 11, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) is pleased to announce that the National Medical Products Administration has approved the initiation of Phase II clinical trials for AK139, a first-in-class IL-4Rα/ST2-targeting...