FDA slaps CRL on Camurus NDA for CAM2029

Shares of Swedish drugmaker Camurus (STO: CAMX) fell almost 10% to 588.50 kroner yesterday after it revealed that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the new drug application (NDA) for CAM2029 (octreotide) extended-release injection for the treatment of patients with acromegaly.

The CRL is attributed to facility-related deficiencies identified during a Current Good Manufacturing Practices (cGMP) inspection of a third-party manufacturer completed in September 2024. The FDA has communicated that its determination of responses from the facility as satisfactory is needed for a timely resolution of the CRL and approval of the NDA. The CRL did not state any other concerns, including related to clinical efficacy or safety of CAM2029.

“The CRL is disappointing, however, we are confident in the data supporting our NDA and the potential of CAM2029 to address unmet medical needs of patients with acromegaly”, says Fredrik Tiberg, Camurus’ president and chief executive. “Camurus is committed to working with the FDA and the third-party manufacturer to bring CAM2029 to patients living with acromegaly as soon as possible,” he added.