Bicycle Therapeutics announces expedited development plan for BT8009

Bicycle Therapeutics announced the company will proceed with its plan to expedite development of BT8009 for metastatic bladder cancer following recent discussions with the FDA. The company has aligned with the FDA on a Phase 2/3 registrational trial, called Duravelo-2, that has an innovative design allowing for potential accelerated approval in untreated (first-line) and previously treated (second-line plus) metastatic bladder cancer. The company plans to initiate the Duravelo-2 trial in the first quarter of 2024.