How FDA Review of Oclaiz Could Shape Camurus’ (OM:CAMX) Long-Term Endocrinology Strategy
- Camurus AB (publ) recently announced that the U.S. FDA has accepted for review its resubmitted New Drug Application for Oclaiz (CAM2029), an extended-release octreotide injection for acromegaly, with a PDUFA target action date set for 10 June 2026.
- This acceptance helps clear a prior hurdle tied to third-party manufacturing observations and follows earlier EU and UK approvals and launch of the same product, marketed there as Oczyesa.
- We will now examine how FDA acceptance of the Oclaiz resubmission, supported by Phase 3 ACROINNOVA data, may influence Camurus’s investment narrative.
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Camurus Investment Narrative Recap
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