Leads Biolabs Reports FDA Fast Track Designation for Opamtistomig in Biliary Tract Cancer
Published in Diseases!, Drugs development & discovery, Immunology.
Published October 12, 2026.
Leads Biolabs announced that the FDA granted Fast Track designation to investigational opamtistomig (LBL-024) for first-line advanced or metastatic biliary tract cancer. The release is dated October 12 in Nanjing and was distributed October 11 at 9:47 p.m. Eastern time.
Opamtistomig is a bispecific antibody targeting PD-L1 and 4-1BB, designed to combine immune-checkpoint blockade with conditional T-cell costimulation. The company says enrollment is complete in its Phase II study combining the antibody with chemotherapy. It plans discussions with the FDA on evidence requirements and a potential U.S. registration strategy.
This is a separate indication from the candidate’s earlier Fast Track designation for extrapulmonary neuroendocrine carcinoma.
Evidence limits: Fast Track designation is a development milestone, not marketing approval or proof of clinical benefit. This announcement provides no new numerical biliary-cancer efficacy results or detailed safety analysis; further clinical evidence remains necessary.
Source: Leads Biolabs announcement via GlobeNewswire, October 12, 2026.