OM:CAMXPharmaceuticals
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...