The FDA has declined to approve CAM2029, for the treatment of acromegaly due to deficiencies at a third-party manufacturing facility, the drugmaker announced.

The manufacturing issues could delay the drug’s approval and subsequent launch by 6 months to 1 year, potentially pushing it to the fourth quarter of 2025, according to analysts.

"The decision is disappointing; however, we are confident in the data supporting our NDA and the potential of CAM2029 to address unmet medical needs for patients with acromegaly," said Camurus CEO Fredrik Tiberg.