Camurus's resubmitted NDA for Oclaiz (CAM2029), a monthly subcutaneous octreotide depot built on the company's FluidCrystal technology and delivered by autoinjector pen, carries an FDA PDUFA target action date of June 10. The resubmission, accepted in January 2026 after a Complete Response Letter tied solely to a third-party manufacturing inspection, rests on data from seven clinical studies including the two Phase 3 ACROINNOVA trials. A clearance would put Oclaiz alongside Crinetics' Palsonify (paltusotine) as the second new-mechanism acromegaly therapy in the past year, with the Camurus FluidCrystal differentiation focused on a small-volume monthly self-injection.
Camurus' Oclaiz (CAM2029), a once-monthly subcutaneous octreotide depot built on the company's FluidCrystal technology and delivered by autoinjector pen, carries an FDA PDUFA target date of June 10 for acromegaly. The resubmitted NDA, accepted after a Complete Response Letter tied to a third-party manufacturing inspection, rests on seven clinical studies including the two Phase 3 ACROINNOVA trials. A clearance would add a peptide depot to the somatostatin-analog market alongside Crinetics' newly launched oral Palsonify.
Crinetics Pharmaceuticals announced April 27 that the European Commission approved Palsonify (paltusotine), a selectively-targeted somatostatin receptor type 2 nonpeptide agonist, as the first once-daily oral therapy for acromegaly in adults across all 27 EU member states plus three EEA countries. The approval rests on two pivotal Phase 3 trials in medical-naïve and previously treated patients, with diarrhea, abdominal pain, and nausea reported as the most common adverse reactions and no serious adverse events in the randomized portion. First launches are planned for Germany and Austria, marking Crinetics' first regulatory approval outside the U.S. and a competitive challenge to injectable somatostatin analogs.