NovaBridge reported that the FDA provided alignment in a Type B meeting on the potential eligibility of givastomig for an accelerated approval pathway in first-line Her2-, CLDN 18.2+, PD-L1+ gastroesophageal cancer. The company said the pathway would be supported by a registrational Phase 3 combination trial using objective response rate as a primary endpoint, which it expects to start as early as Q4 2026. NovaBridge stated that the accelerated approval discussions build on results from a Phase 1b combination trial that have already been presented. Phillip Dennis, Chief Medical Officer, said the company plans to continue discussions with the FDA on final Phase 3 study design details.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. NovaBridge Biosciences published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202603160700PRIMZONEFULLFEED9672445) on March 16, 2026, and is solely responsible for the information contained therein.