US FDA Accepts Camurus' NDA Resubmission for CAM2029 in Acromegaly Treatment

Camurus' NDA Resubmission for CAM2029 Accepted by the FDA

In a significant move for the treatment of acromegaly, Camurus (NASDAQ STO: CAMX) has announced that the US Food and Drug Administration (FDA) has accepted the resubmission of the New Drug Application (NDA) for CAM2029, an extended-release formulation of octreotide. This decision comes after the FDA issued a Complete Response Letter (CRL) on June 10, 2026, which raised concerns regarding a third-party manufacturing facility but did not question the clinical efficacy or safety of CAM2029.

The FDA has established a Prescription Drug User Fee Act (PDUFA) target date for a decision on the application, set for December 18, 2026. This timeline brings hope for patients suffering from acromegaly, particularly since effective treatment options can significantly improve their quality of life.

Fredrik Tiberg, President and CEO of Camurus, stated, "We look forward to continuing the collaboration with the FDA to make CAM2029 available to patients with acromegaly in the United States." This indicates Camurus' commitment to addressing the needs of patients facing this challenging condition.

CAM2029 is an investigational, subcutaneously administered long-acting depot formulation based on the proprietary FluidCrystal® technology developed by Camurus. Designed for monthly self-administration via an autoinjector pen, CAM2029 offers a more convenient treatment option compared to conventional therapies.

The NDA is supported by robust clinical data from a total of seven clinical studies, including two Phase 3 studies under the ACROINNOVA program. These results demonstrate the potential of CAM2029 not just as a strong therapeutic option but also as one that significantly enhances patient adherence through its user-friendly administration method.

Current strategies to treat acromegaly often fall short, leading to reduced quality of life among affected patients. Acromegaly is a rare, progressive disease typically caused by a tumor of the pituitary gland that results in an overproduction of growth hormone. This condition can lead to serious complications, including abnormal growth of bones and tissues, enlarged facial features, hands, and feet, as well as other debilitating symptoms like fatigue, joint pain, and headaches. The estimated prevalence of acromegaly is approximately 60 cases per million, highlighting the importance of finding effective therapies.

Camurus' robust clinical program for CAM2029 includes multiple studies assessing safety and efficacy. Recent results from the Phase 3 ACROINNOVA studies show that CAM2029 provides superior control of biochemical markers compared to placebo, as well as improvements in symptomatology and overall quality of life compared to existing treatment options such as first-generation somatostatin receptor ligands. The safety profile of CAM2029 aligns closely with those of current standard care treatments, indicating a favorable outcome for its introduction into the market.

In addition to its potential use in acromegaly, CAM2029 is also under investigation for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NET) and polycystic liver disease (PLD), indicating its versatility across different disease indications. The current marketing authorization for CAM2029 in the European Union and the UK under the brand name Oczyesa® further supports its global potential.

With the FDA's acceptance of the NDA resubmission, Camurus demonstrates its dedication to advancing innovative therapies for chronic conditions such as acromegaly. As December 2026 approaches, the healthcare community and patients alike will be watching closely for the next steps in this promising journey toward making CAM2029 a valuable treatment option in the United States.

For continued updates on CAM2029 and other innovative treatments by Camurus, stay tuned to their official communications and press releases.