FDA accepts Camurus' resubmitted CAM2029 application for acromegaly review

Camurus AB (Nasdaq Stockholm: CAMX) said the US FDA has [accepted for review its resubmitted New Drug Application](https://www.prnewswire.com/news-releases/camurus-nda-resubmission-for-cam2029-in-acromegaly-accepted-for-review-by-the-us-fda-302828303.html) for [CAM2029](https://app.allsci.com/drugs/ASC-DR-0000000008025-1.0-1757706147), a long-acting subcutaneous octreotide depot, in adults with acromegaly. The agency assigned a PDUFA target action date of December 18, 2026. The filing marks the second resubmission of the CAM2029 NDA after the FDA issued a Complete Response Letter in June 2026 tied to observations from a cGMP inspection at a third-party manufacturer, not to concerns about clinical efficacy or safety. The Sweden-based company said the contract manufacturer has completed remediation and confirmed inspection readiness ahead of the resubmission. This is the drug's third pass through FDA review: an earlier CRL, received before January 2026, also stemmed from manufacturing-site findings rather than clinical data, and led to a resubmission that was accepted with a PDUFA date of June 10, 2026 before the second CRL intervened. CAM2029 already holds marketing authorization in the European Union and the UK, where it is sold as Oczyesa, and additional applications are under review in two other markets. A US approval would give Camurus its first American label for the product, more than a year after its European launch began. CAM2029 delivers octreotide, a somatostatin analog, through Camurus' FluidCrystal lipid depot technology, which forms a gel matrix under the skin that releases the drug over roughly a month following a single subcutaneous injection. The formulation is designed to be self-administered via a prefilled autoinjector pen, in contrast to the intramuscular or clinic-administered lanreotide and octreotide long-acting-release products that have anchored first-line acromegaly therapy for over two decades. The NDA rests on seven studies, including two Phase III trials in the [ACROINNOVA ](https://app.allsci.com/news/ASC-NR-0000000133939-1.0-1769544552?query=CAM2029)program, one of which reported superior biochemical control against placebo alongside improvements in symptoms and treatment satisfaction versus standard-of-care somatostatin analogs. The regulatory holdup has been procedural rather than scientific, but it has delayed Camurus' entry into a US market where competitors have been advancing. Crinetics Pharmaceuticals' oral paltusotine (Palsonify) received FDA approval in September 2025, offering patients a pill-based alternative to injectable therapy. Debiopharm's Debio 4126, a quarterly octreotide formulation, entered Phase III testing in late 2025, targeting the same injection-frequency burden that CAM2029 is designed to reduce. Pasireotide and pegvisomant remain options for patients who fail first-generation analogs, though both carry tolerability trade-offs such as hyperglycemia or daily dosing. For Camurus, the US filing is central to a broader long-acting depot strategy that also includes an expanded FluidCrystal licensing deal with Eli Lilly covering incretin compounds, announced earlier this year. Royalty income from that and other partnerships has been growing faster than product sales, according to the company's full-year 2025 results, underscoring how a US approval for CAM2029 would diversify revenue beyond licensing income and its existing European commercial base. Camurus also has CAM2029 in Phase III development for gastroenteropancreatic neuroendocrine tumors and in earlier-stage testing for polycystic liver disease, indications that would not be affected by the acromegaly filing's outcome. *** This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: [https://allsci.com/news/](https://allsci.com/news/) --- Spot something wrong? [Report an issue with this article](https://newsgen-prod.reframedata.com/feedback/cam2029-acromegaly-fda-approval-accepts-camurus)