Cabaletta Bio shares rise 16.67% premarket after FDA clears automated CAR T manufacturing for rese-cel.

Cabaletta Bio surged 16.67% in premarket trading, driven by two key developments. First, the FDA cleared Cellares’ automated CAR T manufacturing platforms for use in Cabaletta’s rese-cel therapy, marking the first clinical application of these scalable systems and advancing its autoimmune disease pipeline. Second, insider purchases by executives, including the General Counsel and Chief Medical Officer, signaled strong confidence in the company’s strategic and clinical progress. These events, combined with optimism around the RESET program’s 2025 data timeline, fueled investor enthusiasm despite ongoing financial challenges.