Camurus updates on regulatory process for CAM2029 in the USA
FDA issued a request for additional information regarding the application for marketing approval for CAM2029 (Oclaiz) for acromegaly.
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Swedish biopharmaceutical company developing long-acting medicines
camurus.comLast updated
In short: Camurus achieved record revenues and strategic milestones, including the FDA acceptance of its resubmitted NDA for acromegaly drug Oclaiz.
FDA issued a request for additional information regarding the application for marketing approval for CAM2029 (Oclaiz) for acromegaly.
Lilly exercises option for amylin agonists. Camurus receives up to 870 million USD in milestone payments.
Revenues decreased 5% and FDA accepted application for Oclaiz.
The annual report is available on the website in ESEF format. During 2025, growth, increased profitability and progress in the portfolio were achieved. Sustainability report is included.
The FDA has accepted Camurus' resubmitted NDA for CAM2029 (octreotide) extended-release injection for acromegaly, setting a PDUFA date of December 18, 2026.
Earnings call Camurus delivered Q1 2026 results in line with guidance: revenue of SEK 533 million rose 15% sequentially but declined 5% YoY due to...
2026-07-15. The following slide deck was published by Camurus AB (publ) in conjunction with their 2026 Q2 earnings call.
Wall Street has pushed to next year expectations for a U.S. approval for Camurus' drug to treat a rare hormonal condition after the health regulator's...
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