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US FDA Accepts Camurus' Resubmitted Application for Acromegaly Treatment CAM2029

MT Newswires·07/17/2026 02:20:06
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02:20 AM EDT, 07/17/2026 (MT Newswires) -- Camurus (CAMX.ST) said Friday its resubmitted new drug application for CAM2029 was accepted by the US Food and Drug Administration. CAM2029 is an octreotide extended-release injection intended for the treatment of patients with acromegaly. The application was resubmitted after the FDA issued a complete response letter on June 10 regarding observations related to a third-party manufacturer. Camurus noted that the FDA letter did not raise any concerns regarding CAM2029's clinical efficacy or safety. Marketed under the Oczyesa name, CAM2029 is approved for treating acromegaly in the European Union and the UK.