Camurus’ NDA resubmission for CAM2029 in acromegaly accepted for review by the US FDA
PDUFA target action date set to 18 December 2026 Lund, Sweden — 17 July 2026 — Camurus (NASDAQ STO: CAMX) today announced that the US Food and Drug Administration (FDA) has accepted for review the resubmission of the New Drug Application (NDA) for CAM2029, octreotide extended-release injection, for the treatment of patients with acromegaly. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of 18 December 2026. The resubmission follows the Complete Response Letter (CRL) issued by the FDA on 10 June 2026, which related to observations from a cGMP