The FDA set a Dec. 18, 2026 PDUFA date after accepting the resubmission, which followed a complete response letter tied to third-party manufacturing inspection findings.
Camurus said the U.S. Food and Drug Administration accepted for review the company’s resubmitted New Drug Application for CAM2029, an octreotide extended-release injection for acromegaly, and set a Prescription Drug User Fee Act target action date of Dec. 18, 2026. The resubmission follows a Complete Response Letter issued on June 10, 2026 that was tied to observations from a cGMP inspection at a third-party manufacturer rather than concerns about CAM2029’s clinical efficacy or safety. Camurus said the contract manufacturer has completed remediation measures and confirmed inspection readiness. CAM2029 is an investigational, subcutaneous long-acting octreotide depot designed for once-monthly self-administration via an autoinjector pen, with the U.S. filing supported by seven clinical studies including two Phase 3 trials in the ACROINNOVA program. The product is already authorized for acromegaly in the European Union and the United Kingdom under the brand name Oczyesa.