The Swedish biopharmaceutical firm Camurus is moving forward with its US market entry for the long-acting subcutaneous injection. The latest regulatory milestone arrives after the FDA issued a Complete Response Letter on June 10, 2026, which flagged observations at a third-party manufacturing site. Camurus confirmed that the contractor has completed all necessary remediation steps to meet required standards.
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US FDA Accepts Camurus Resubmission for Acromegaly Treatment
The US Food and Drug Administration has accepted the resubmitted application for CAM2029, an investigational octreotide treatment for acromegaly, setting a target action date of December 18, 2026. This move follows a previous regulatory hurdle centered on manufacturing inspection protocols rather than clinical concerns regarding safety or efficacy.
CAM2029, which utilizes the proprietary FluidCrystal technology for once-monthly self-administration, is already authorized in the European Union and the United Kingdom under the brand name Oczyesa. Clinical support for the application includes the ACROINNOVA program, which demonstrated superior biochemical control and patient quality-of-life improvements compared to existing standard-of-care treatments.
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