Camurus Receives FDA Green Light for Oclaiz™ to Combat Acromegaly

Camurus Receives FDA Acceptance for Oclaiz™ Resubmission

In a significant milestone, Camurus (NASDAQ STO: CAMX) recently declared that the U.S. Food and Drug Administration (FDA) has accepted its resubmission of the New Drug Application (NDA) for Oclaiz™ (CAM2029), an extended-release injection of octreotide aimed at treating patients with acromegaly. This development comes with a Prescription Drug User Fee Act (PDUFA) target action date set for June 10, 2026, paving the way for potential availability of this treatment option in the United States.

Fredrik Tiberg, President and CEO of Camurus, expressed optimism regarding the ongoing collaboration with the FDA, stating, "We look forward to the continued collaboration with the FDA to make Oclaiz available to patients with acromegaly in the US as soon as possible."

Understanding Acromegaly

Acromegaly is a rare, progressive disorder predominantly caused by a tumor in the pituitary gland that produces excess growth hormone. This overproduction results in elevated levels of insulin growth factor-1 (IGF-1), which leads to abnormal growth of bones and tissues. Patients often experience enlarged hands and feet, pronounced facial features, and other internal organ growth, alongside debilitating symptoms like fatigue, joint pain, and excessive sweating. With a prevalence of approximately 60 cases per million, acromegaly poses significant challenges for affected individuals, markedly reducing their quality of life and longevity if left unmanaged.

About Oclaiz™ (CAM2029)

Oclaiz™ is a subcutaneous long-acting octreotide depot designed for optimized disease management and easy self-administration by patients. Developed using Camurus' proprietary FluidCrystal® technology, this treatment comes in the form of a monthly injection with an autoinjector pen featuring a thin, concealed needle. The recent NDA resubmission to the FDA, filed on December 10, 2025, was based on extensive evidence gathered from seven clinical trials, including two Phase 3 studies under the ACROINNOVA program.

The data showed that CAM2029 boasts approximately five times higher bioavailability compared to the existing long-acting octreotide formulations. Clinical results indicated that patients treated with CAM2029 had a significantly higher likelihood of reaching normal IGF-1 levels compared to those receiving a placebo. Moreover, the long-term follow-up in the ACROINNOVA studies demonstrated sustained control of IGF-1 levels and notable improvements in patients' quality of life.

The most common side effects encountered during trials included gastrointestinal disorders, certain nervous system issues, and local reactions at the injection site, yet overall treatment satisfaction remained high.

Market Authorization and Future Development

Oclaiz™ received marketing authorization in the EU and the UK in 2025, branded as Oczyesa®, with the launch process currently underway. Beyond acromegaly, CAM2029 is also being explored for additional severe chronic diseases, including gastroenteropancreatic neuroendocrine tumors (GEP-NET) and polycystic liver disease (PLD), showcasing Camurus' commitment to enhancing treatment options for patients with diverse and complex health needs.

About Camurus

Camurus is a biopharmaceutical company based in Lund, Sweden, dedicated to the development and commercialization of innovative long-acting medications aimed at improving patient outcomes in chronic and severe conditions. The company's pipeline encompasses a wide array of therapies targeting dependences, pain management, cancer treatment, and endocrine disorders. With its shares traded on Nasdaq Stockholm under the ticker CAMX, Camurus continues to extend its influence across Europe, the United States, and Australia. For additional information, visit Camurus' official website or their LinkedIn profile.

The acceptance of the NDA for Oclaiz™ marks a hopeful step for patients suffering from acromegaly, signifying advancements in treatment possibilities through innovative pharmaceutical solutions.