LUND, Sweden, July 17, 2026
Camurus announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for CAM2029, an investigational extended-release octreotide subcutaneous injection, for the treatment of acromegaly. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 18, 2026, marking an important regulatory milestone for the company’s endocrine disease portfolio. The NDA resubmission follows the Complete Response Letter (CRL) issued in June 2026, which was related solely to cGMP inspection observations at a third-party manufacturing facility and did not identify any concerns regarding the clinical efficacy or safety of CAM2029. According to Camurus, the contract manufacturer has completed all required remediation measures and confirmed readiness for future regulatory inspections, allowing the FDA review process to move forward.
CAM2029 Designed to Improve Long-Term Acromegaly Management
CAM2029 is an investigational once-monthly, extended-release octreotide depot developed using Camurus’ proprietary FluidCrystal® technology. Unlike conventional long-acting intramuscular therapies, CAM2029 is administered as a subcutaneous injection through a prefilled autoinjector pen, enabling patients to perform convenient self-administration at home. The therapy is intended to provide enhanced octreotide exposure while reducing treatment burden for individuals living with acromegaly, a rare endocrine disorder caused primarily by growth hormone-secreting pituitary tumors. Persistent excess growth hormone and elevated insulin-like growth factor-1 (IGF-1) levels can lead to abnormal bone and tissue growth, enlarged organs, fatigue, headaches, joint pain, excessive sweating, visual disturbances, and reduced quality of life. Improved long-term biochemical control remains a key objective in acromegaly management to reduce disease-related complications and improve patient outcomes.
Clinical Program Demonstrated Strong Efficacy and Safety
The CAM2029 NDA is supported by data from seven clinical studies, including four Phase 1 trials, one Phase 2 study, and two pivotal Phase 3 ACROINNOVA clinical trials. Across the development program, CAM2029 demonstrated approximately five-fold greater bioavailability compared with currently available long-acting intramuscular octreotide formulations. The Phase 3 ACROINNOVA program showed superior biochemical control compared with placebo while also demonstrating improvements in symptom control, treatment satisfaction, and patient quality of life compared with baseline treatment using first-generation somatostatin receptor ligands (SRLs), including octreotide and lanreotide. The investigational therapy maintained a safety profile consistent with existing standard-of-care treatments, with no new safety findings identified during clinical development, supporting its potential as a differentiated treatment option for patients requiring long-term hormone control.
Advertisement
FDA Review Builds on Existing European Approval
The FDA review represents another significant regulatory milestone for CAM2029, which has already received marketing authorization in the European Union and the United Kingdom under the brand name Oczyesa® for the treatment of acromegaly. In addition to the U.S. submission, regulatory applications are currently under review in two additional international markets, reflecting Camurus’ broader global commercialization strategy. Beyond acromegaly, the company is also evaluating CAM2029 for additional indications, including gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and polycystic liver disease (PLD). With the FDA review now underway and a December 18, 2026 PDUFA decision date established, Camurus continues to advance its long-acting FluidCrystal® technology platform toward expanding treatment options for patients living with serious endocrine and chronic diseases.
Source:Camurus press release
