# Oclaiz (CAM2029, octreotide subcutaneous depot) PDUFA Event: Acromegaly

Canonical URL: https://biopharmsignal.com/pdufa-calendar/CAMX/oclaiz-acromegaly-review-2

Ticker: CAMX

Company: Camurus

Event date: 2026-06-10

Event type: FDA Decision

Stage: PDUFA

Result: Complete Response Letter

Result date: 2026-06-10

Application type: NDA

Review cycle: 2

FDA issued a Complete Response Letter. FDA said the NDA could not be approved until observations from a third-party manufacturer's September 2024 cGMP inspec...

## Event Timeline

### June 10, 2026 — FDA issued a Complete Response Letter

FDA said the NDA could not be approved until observations from a third-party manufacturer's September 2024 cGMP inspection were satisfactorily resolved and also recommended a packaging-label change. The CRL did not concern CAM2029 clinical efficacy or safety.

[Camurus — June 2026 Oclaiz Complete Response Letter](https://www.camurus.com/media/press-releases/2026/camurus-provides-regulatory-update-on-the-us-nda-for-cam2029-oclaiz-in-acromegaly/)

### January 9, 2026 — FDA accepted the NDA resubmission

FDA accepted the December 2025 resubmission and assigned a June 10, 2026 PDUFA target action date.

[Camurus — Oclaiz NDA resubmission acceptance](https://www.camurus.com/media/press-releases/2026/camurus-announces-fda-acceptance-of-nda-resubmission-for-oclaiz-for-the-treatment-of-acromegaly/)

### December 10, 2025 — Camurus resubmitted the NDA

Camurus submitted an updated application following the first-cycle CRL, which had been limited to observations at a third-party manufacturing facility.

[Camurus — Oclaiz NDA resubmission acceptance and prior history](https://www.camurus.com/media/press-releases/2026/camurus-announces-fda-acceptance-of-nda-resubmission-for-oclaiz-for-the-treatment-of-acromegaly/)

### October 8, 2024 — ACROINNOVA 1 results were published

The randomized placebo-controlled Phase 3 study showed superior biochemical control with monthly CAM2029 and supported the efficacy portion of the NDA.

[Camurus — Oclaiz CRL update and ACROINNOVA 1 publication](https://www.camurus.com/media/press-releases/2026/camurus-provides-regulatory-update-on-the-us-nda-for-cam2029-oclaiz-in-acromegaly/)

### July 15, 2024 — ACROINNOVA 2 reported positive final results

The 52-week Phase 3 safety and extension study supported long-term efficacy and safety of monthly subcutaneous CAM2029.

[Camurus — ACROINNOVA 2 final topline results](https://www.camurus.com/media/press-releases/2024/camurus-announces-positive-phase-3-results-from-the-acroinnova-2-study-of-octreotide-sc-depot-cam2029-in-acromegaly-patients/)

### August 19, 2019 — Phase 3 ACROINNOVA 1 study started

The pivotal randomized trial began evaluating the efficacy and safety of octreotide subcutaneous depot in patients with acromegaly.

[ClinicalTrials.gov — ACROINNOVA 1 study record (NCT04076462)](https://clinicaltrials.gov/study/NCT04076462)

## Related Pages

- CAMX PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/CAMX.md

- CAMX company profile: https://biopharmsignal.com/company/CAMX.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md