Peptide News Digest

#Cam2029

2 stories

Regulatory · View digest

Camurus Discloses Second Complete Response Letter for Oclaiz, Both Tied to the Same Manufacturer Inspection

Camurus said on June 10 that the FDA had issued a Complete Response Letter on the Oclaiz (CAM2029) NDA, the second the program has received and the second based solely on unresolved observations from a September 2024 cGMP inspection at a third-party contract manufacturer. The CRL did not cite clinical efficacy or safety. Camurus expects to resubmit in Q4 2026 with a second validated manufacturer; an approval pushed to the first half of 2027 leaves the US launch about a year behind the EU and UK rollouts (under the Oczyesa brand) that landed in 2025.

Regulatory · View digest

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.