Camurus received another complete response letter from the FDA for its monthly subcutaneous extended-release acromegaly drug CAM-2029, which is expected to be branded Oclaiz in the U.S. The rejection marks a repeat FDA no, with Camurus citing problems at a third-party manufacturer as the new basis for the CRL. The company’s related EU and UK product, Oczyesa, received marketing authorization in 2025, but the U.S. pathway continues to stall. The latest outcome keeps pressure on Camurus’ timeline for bringing a long-acting somatostatin analog option to the acromegaly market. For the broader industry, the CRL underscores ongoing regulatory sensitivity around manufacturing and product release for complex formulations.