Camurus Oclaiz (CAM2029, Octreotide Subcutaneous Depot) FDA PDUFA Set for June 10 — Next Peptide Depot Decision in Acromegaly After Crinetics Palsonify EU Win
Camurus's Oclaiz (CAM2029) — a once-monthly subcutaneous octreotide FluidCrystal depot delivered via prefilled autoinjector — has an FDA Prescription Drug User Fee Act target action date of June 10, 2026, following an October 2024 Complete Response Letter tied to a third-party manufacturer's cGMP inspection. CAM2029's ACROINNOVA Phase 3 program documented approximately five-fold higher bioavailability versus the currently approved long-acting intramuscular octreotide formulation. The June PDUFA sets up a back-to-back acromegaly decision pair with Crinetics' Palsonify (paltusotine), already approved in the EU on April 27 and reported $10.3M in Q1 US net product revenue (covered above). Both target the same patient population through different routes — once-daily oral nonpeptide vs once-monthly subcutaneous peptide depot.