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FDA accepts resubmission of Camurus' CAM2029 NDA for acromegaly with decision due Dec 18, 2026

Market News
17 Jul 2026
PRNewsWire
View Source
Bullish
FDA accepts resubmission of Camurus' CAM2029 NDA for acromegaly with decision due Dec 18, 2026

Camurus announced that the US FDA has accepted the resubmission of the New Drug Application (NDA) for CAM2029, an extended-release octreotide injection for treating acromegaly. The FDA set a Prescription Drug User Fee Act (PDUFA) target action date of December 18, 2026. This follows a previous Complete Response Letter related to manufacturing inspection issues, which have since been resolved without concerns about the drug's safety or efficacy. CAM2029 is already approved in the EU and UK and offers once-monthly self-administration via an autoinjector pen, with clinical trials showing superior biochemical control and improved patient outcomes compared to existing treatments. The FDA review outcome will determine its availability in the US market.

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