Business
Camurus announces FDA acceptance of NDA resubmission for Oclaiz™ for the treatment of acromegaly
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.
About this update from Camurus Ab
[{"type":"text","content":"PDUFA target action date set to 10 June 2026 ","length":44,"tagName":"p","attribs":{}},{"type":"text","content":"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.","length":430,"tagName":"p"},{"type":"text","content":""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.","length":211,"tagName":"p"},{"type":"text","content":"Oclaiz is a subcutaneous long-acting octreotid depot, designed for optimized disease control and convenient self-administration. The product is based on Camurus' FluidCrystal® technology and is administrated once monthly with an autoinjector pen.","length":250,"tagName":"p"},{"type":"text","content":"The application is supported by data from seven clinical studies, including two Phase 3 studies in the ACROINNOVA program. The updated NDA was submitted to the FDA on 10 December 2025 following a Complete Response Letter (CRL) earlier issued by the Agency, which solely related to observations during a cGMP inspection at a third-party manufacturer's facility.","length":364,"tagName":"p"},{"type":"text","content":"The product received marketing authorization in the EU and UK in 2025 under the product name Oczyesa®.1 The product launch has recently been initiated in the EU.","length":161,"tagName":"p"},{"type":"text","content":"For more informationFredrik Tiberg, President & CEOTel. +46 (0)46 286 46 [email protected]","length":108,"tagName":"p"},{"type":"text","content":"Fredrik Joabsson, Chief Business Development OfficerTel. +46 (0)70 776 17 [email protected]","length":92,"tagName":"p"},{"type":"text","content":"About acromegaly","length":16,"tagName":"p"},{"type":"text","content":"Acromegaly is a rare, slowly progressive disease, typically caused by a tumor of the pituitary gland producing excess growth hormone and stimulating increased insulin growth factor-1 (...