Oclaiz (CAM2029, octreotide subcutaneous depot)

Note: CRL issued on the PDUFA date itself (2026-06-10), announced same day by Camurus AB in an official company press release titled "Camurus provides regulatory update on the US NDA for CAM2029 (Oclaiz) in acromegaly". This is the SECOND manufacturing-related CRL for this NDA: the first was announced 2024-10-22 after a September 2024 cGMP inspection at a third-party manufacturer; the December 2025 resubmission carried the 2026-06-10 PDUFA date and was again turned down on the same facility grounds. Cause is explicitly CMC/facility, NOT clinical — the release states the CRL "does not relate to the clinical efficacy or safety of CAM2029"; FDA additionally recommended a labeling change to the oxygen absorber component of the packaging. CEO Fredrik Tiberg: "The CRL is disappointing. We are working toward resubmission of the NDA in the near term, while maintaining launch readiness and with no change to our 2026 financial outlook." Source: https://www.camurus.com/media/press-releases/2026/camurus-provides-regulatory-update-on-the-us-nda-for-cam2029-oclaiz-in-acromegaly/