Camurus says FDA accepts CAM2029 acromegaly NDA resubmission, sets Dec. 18, 2026 PDUFA date

• Camurus received US FDA acceptance for review of its resubmitted NDA for CAM2029, an octreotide extended-release injection for acromegaly.
• The FDA set a PDUFA target action date of Dec. 18, 2026.
• The resubmission follows a June 10 complete response letter tied to cGMP inspection findings at a third-party manufacturer, not clinical efficacy or safety.
• The contract manufacturer completed remediation actions and confirmed inspection readiness.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Camurus AB published the original content used to generate this news brief via Cision (Ref. ID: 202607170100BITN____UKPR__EN_20260717-BIT-9817-0) on July 17, 2026, and is solely responsible for the information contained therein.