FDA Accepts Camurus' CAM2029 Application for Review

The U.S. Food and Drug Administration (FDA) has accepted for review Camurus' resubmitted New Drug Application (NDA) for CAM2029, an octreotide extended-release injection for the treatment of acromegaly. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 18, 2026.

The resubmission follows a Complete Response Letter (CRL) issued by the FDA on June 10, 2026. The CRL was related to observations from a current Good Manufacturing Practice (cGMP) inspection.

CAM2029 is a long-acting formulation developed by Camurus intended to reduce tumor size and hormone levels in patients with acromegaly.

Acromegaly is a rare hormonal disorder caused by excessive growth hormone production, leading to serious health issues if left untreated.