FDA Accepts Camurus' CAM2029 for Acromegaly Review
The U.S. Food and Drug Administration (FDA) has accepted a resubmitted New Drug Application for Camurus' CAM2029, an extended-release octreotide injection for acromegaly treatment. A decision is expected by December 18, 2026.
FDA Accepts Camurus' CAM2029 for Acromegaly Treatment Review
LUND, Sweden – Camurus (NASDAQ STO: CAMX) announced on July 17, 2026, that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of its New Drug Application (NDA) for CAM2029. If approved, the drug would be used for the treatment of acromegaly. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of 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 manufacturing facility. Importantly, 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 subcutaneous, long-acting octreotide depot formulation developed using Camurus' proprietary FluidCrystal® technology. It is designed for once-monthly self-administration using an autoinjector pen. The NDA is supported by data from seven clinical studies, including two Phase 3 studies within the ACROINNOVA program.
CAM2029 has already received marketing authorization for acromegaly in the European Union and the United Kingdom under the brand name Oczyesa®. Camurus is now awaiting the FDA's comprehensive review to potentially make this treatment available to patients in the United States.