Camurus AB-Second CRL for CAM2029 in acromegaly-06/11/2026

Research evidence excerpt

Camurus AB-Second CRL for CAM2029 in acromegaly-06/11/2026

Camurus AB

NEWSFLASH | 11 JUN 2026

Second CRL for CAM2029 in acromegaly

Camurus yesterday evening announced that it received a complete response letter (CRL) from the FDA regarding the

CAM2029 NDA. The CRL still relates to manufacturing observations at Camurus’ third-party manufacturer and a

recommended label change. Consequently, we expect a delay of the US approval into 1H 2027, but do not see an increased

risk that the drug does not get approved. While the delay is negative, the largest trigger for CAM2029 this year (2H) will be

CAM2029’s phase 3 trial readout in neuroendocrine tumors, that aims to show superiority over standard of care.

Dan Akschuti

+41 445 51 3823, da@paretosec.com

Chien-Hsun Lee

+41 445 51 3822, chien-hsun.lee@paretosec.com

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