CRL issued for CAM2029 in acromegaly

What this means

Oclaiz (CAM2029) is Camurus's ready-to-use subcutaneous octreotide, formulated on the FluidCrystal platform, for adults with acromegaly — a rare pituitary disorder in which a benign tumor drives excess growth hormone and IGF-1, causing enlarged features, joint pain, sleep apnea, and cardiovascular complications. FDA declined to approve the NDA, citing observations from a September 2024 cGMP inspection at a third-party contract manufacturer (satisfactory resolution — potentially including reinspection — is required before approval) plus a recommended labeling change to the oxygen absorber component of the product packaging. Camurus stated the CRL does not relate to the clinical efficacy or safety of CAM2029. Second CMO-driven quality-cause CRL identified this week alongside Elevar's rivoceranib-camrelizumab (2026-07-10) and Sobi's NASP (2026-06-26).