Swedish biopharmaceutical company Camurus (STO: CAMX), which develops long-acting medicines for severe and chronic diseases, said on Friday that the US Food and Drug Administration (FDA) has accepted for review its resubmitted New Drug Application for Oclaiz (CAM2029) to treat acromegaly.

Oclaiz is a once-monthly, subcutaneous long-acting octreotide depot designed for self-administration using an autoinjector pen and is based on Camurus' FluidCrystal technology.

The NDA is supported by data from seven clinical studies, including two Phase 3 trials in the ACROINNOVA programme. The updated application was submitted on 10 December 2025 following a Complete Response Letter that related solely to observations from a cGMP inspection at a third-party manufacturing facility.

Oclaiz received marketing authorisation in the European Union and the United Kingdom in 2025 under the name Oczyesa, and launch activities have recently begun in the European Union. The drug is also under development for gastroenteropancreatic neuroendocrine tumours and polycystic liver disease.

The FDA has set a Prescription Drug User Fee Act target action date of 10 June 2026.