FDA accepts CAM2029 NDA resubmission for Acromegaly, sets December 2026 PDUFA Date – Camurus
Camurus announced that the FDA has accepted for review the resubmission of the New Drug Application (NDA) for CAM2029, octreotide extended-release injection, for the treatment of patients with acromegaly. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of 18 December 2026.
The resubmission follows the Complete Response Letter (CRL) issued by the FDA on 10 June 2026, which related to observations from a cGMP inspection at a third-party manufacturer. The CRL did not raise any concern regarding the clinical efficacy or safety of CAM2029. The contract manufacturer has implemented all remediation actions and has confirmed inspection readiness.
“We look forward to continuing the collaboration with the FDA to make CAM2029 available to patients with acromegaly in the United States.” – Fredrik Tiberg, President & CEO, Camurus.
CAM2029 is an investigational, subcutaneous long-acting octreotide depot based on Camurus’ proprietary FluidCrystal technology, designed for once-monthly self-administration via an autoinjector pen. The NDA is supported by data from seven clinical studies, including two Phase 3 studies in the Acroinnova program.
CAM2029 has been granted marketing authorization for acromegaly in the European Union and the United Kingdom under the product name Oczyesa¹. In addition, marketing authorization applications are under review in two additional countries.
