Camurus received a second complete response letter (CRL) from the FDA for its subcutaneous extended-release acromegaly drug CAM-2029 (Oclaiz in the U.S.), with the rejection tied to issues at a third-party manufacturer. The company previously obtained EU and U.K. marketing authorization for the same product. Camurus said the new FDA action is for manufacturing-related problems at an external site, adding to the operational hurdles that can delay approval timelines for long-acting injectables. The update comes as the company continues to navigate clinical and manufacturing readiness across multiple jurisdictions. For industry watchers, the repeat CRL highlights how even non-clinical quality and supply chain factors can become the dominant gating items for long-duration products.