Camurus announces FDA acceptance of NDA resubmission for Oclaiz™ for the treatment of acromegaly

PDUFA target action date set to 10 June 2026

LUND, Sweden, Jan. 9, 2026 /PRNewswire/ — Camurus (NASDAQ STO: CAMX) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s resubmission of the New Drug Application (NDA) for Oclaiz™ (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 10 June 2026.

„We look forward to the continued collaboration with the FDA to make Oclaiz available to patients with acromegaly in the US as soon as possible,“ says Fredrik Tiberg, President & CEO, Camurus.