US FDA accepts Camurus' CAM2029 resubmission for acromegaly for review
The US Food and Drug Administration (FDA) has accepted for review Camurus' resubmitted New Drug Application (NDA) for CAM2029, a treatment for acromegaly.
Swedish biopharmaceutical company Camurus announced on July 17, 2026, that the US Food and Drug Administration (FDA) has accepted for review the resubmission of its New Drug Application (NDA) for CAM2029. The drug is intended for the treatment of patients with acromegaly, a condition characterized by excessive growth hormone production. The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) to December 18, 2026.
The resubmission follows a Complete Response Letter (CRL) issued by the FDA on June 10, 2026. The CRL was related to observations from a current Good Manufacturing Practice (cGMP) inspection at a third-party manufacturer. The FDA stated that the CRL did not raise concerns regarding the clinical efficacy or safety of CAM2029. The contract manufacturer has reportedly implemented all necessary remediation actions and confirmed inspection readiness.
CAM2029 is an investigational, long-acting octreotide injection designed for subcutaneous administration. It utilizes Camurus' proprietary FluidCrystal® technology and is intended for once-monthly self-administration using an autoinjector pen. The NDA is supported by data from seven clinical studies, including two Phase 3 studies.
CAM2029 has already received marketing authorization for acromegaly in the European Union and the United Kingdom under the product name Oczyesa®. Marketing authorization applications are also under review in two additional countries. Acromegaly is a rare disorder typically caused by a pituitary gland tumor leading to excess growth hormone.