Camurus provides regulatory update on the US NDA for CAM2029 (Oclaiz™) in acromegaly
Lund, Sweden — 10 June 2026 — Camurus (NASDAQ STO: CAMX) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the new drug application (NDA) for CAM2029 (Oclaiz™), octreotide extended-release injection, for the treatment of patients with acromegaly. The CRL relates to the observations from the September 2024 cGMP inspection at a third-party manufacturer. FDA has indicated that satisfactory resolution of these observations, which could include a reinspection of the facility, is required before the NDA can be approved. FDA