Camurus provides regulatory update on the US NDA for CAM2029 in acromegaly
· The FDA issues a Complete Response Letter for CAM2029 pending FDA’s assessment of responses from a third-party manufacturer to observations from a recently completed cGMP inspection · Camurus will work with the FDA and the manufacturer to resolve any potential outstanding observations Lund, Sweden — 22 October 2024 — Camurus (NASDAQ STO: CAMX) today announced that the U.S. 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