Swedish biopharmaceutical company Camurus AB (STO:CAMX) said on Friday that the US Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application for CAM2029, an extended-release octreotide injection for acromegaly, and set a PDUFA target action date of 18 December 2026.

The resubmission follows a Complete Response Letter issued on 10 June 2026 that cited observations from a cGMP inspection at a third-party manufacturer. No concerns were raised about the therapy's clinical efficacy or safety. The contract manufacturer has completed remediation measures and confirmed its inspection readiness.

CAM2029 is an investigational once-monthly, subcutaneous octreotide depot based on Camurus' FluidCrystal technology and is administered using an autoinjector pen.

The application is supported by data from seven clinical studies, including two Phase 3 trials in the ACROINNOVA programme. The therapy has already received marketing authorisation in the European Union and the United Kingdom under the name Oczyesa, while applications remain under review in two additional countries.