UKBiotech & Genomic Medicine▲
FDA accepts Camurus' resubmitted NDA for CAM2029 with December 2026 PDUFA date
The U.S. Food and Drug Administration has accepted Camurus' resubmitted New Drug Application for CAM2029 for the treatment of acromegaly, setting a Prescription Drug User Fee Act date of December 18, 2026. The resubmission follows a Complete Response Letter issued on June 10, 2026, which cited observations from a manufacturing inspection at a third-party facility but raised no issues regarding clinical efficacy or safety. Camurus stated that the manufacturer has completed all required remediation actions and confirmed inspection readiness. CAM2029 is an investigational once-monthly subcutaneous octreotide depot that has shown superior biochemical control and improved quality of life in clinical trials, and is already approved in the European Union and the United Kingdom under the brand name Oczyesa.