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LUND, Sweden - Camurus (market cap: $55.97M) announced today that the Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for the market authorization of Oczyesa®, a treatment for acromegaly in adults. This recommendation is a significant step towards the European Commission’s final decision expected in mid-2025. According to InvestingPro analysis, while the company maintains a GREAT financial health score of 3.3, it currently faces challenges with its profit margins.
Oczyesa®, also known as CAM2029, is a long-acting subcutaneous depot of octreotide, designed for once-monthly self-administration using an autoinjector pen. It is intended for patients with acromegaly who have shown a positive response to somatostatin analogues treatment.
The CHMP’s favorable opinion is based on results from a comprehensive clinical program, which includes seven clinical trials with two pivotal Phase 3 studies. The studies highlighted that Oczyesa® led to a higher proportion of patients achieving normalized insulin growth-factor-1 (IGF-1) levels, which is crucial for managing acromegaly. It also showed improvements in patient symptoms, quality of life, and treatment satisfaction over a 52-week period compared to the standard of care at the study’s outset. For investors tracking Camurus’s progress, InvestingPro subscribers can access detailed financial analysis and additional insights about the company’s growth trajectory.
Fredrik Tiberg, President & CEO of Camurus, expressed satisfaction with the CHMP’s recommendation, noting the potential benefits of Oczyesa® in enhancing patient care for those living with acromegaly. He emphasized the drug’s ability to increase octreotide plasma exposure and the convenience of its once-monthly self-administration.
Acromegaly is a rare disease often caused by a pituitary gland tumor, leading to excess growth hormone production and elevated IGF-1 levels. This results in abnormal growth and various symptoms that can significantly impact patients’ quality of life.
Oczyesa® has been developed using Camurus’ proprietary FluidCrystal® technology and has received orphan drug designation for acromegaly in the EU, as well as for polycystic liver disease in both the EU and the US.
The most common side effects reported during the clinical studies were gastrointestinal, nervous system, hepatobiliary, metabolism and nutritional disorders, and reactions at the injection site.
Camurus, a biopharmaceutical company focused on developing long-acting medicines for severe and chronic diseases, awaits the European Commission’s final verdict, which will determine the availability of Oczyesa® in the European market. The company’s stock has shown resilience with a 1.35% return over the past year, trading near $28.75, despite broader market challenges. Discover more comprehensive financial metrics and expert analysis with InvestingPro, including additional ProTips and detailed valuation metrics. This information is based on a press release statement and market data.
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