Camurus AB: Camurus receives approval in Canada for Oczyesa® XR, a once-monthly, self-administered treatment for acromegaly

Lund, Sweden - 12 October 2026 - Camurus (NASDAQ STO: CAMX) today announced that Health Canada has issued a Notice of Compliance (NOC) for Oczyesa^® XR, octreotide subcutaneous depot, for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogs.¹

"Oczyesa XR offers people with acromegaly sustained control of their disease with a once-monthly injection they can take themselves, at home, instead of relying on clinic visits. We look forward to the launch of Oczyesa XR in Canada and to making it available to patients", says Fredrik Tiberg, President and CEO of Camurus.

The approval is based on a clinical program of seven studies, including the two Phase 3 studies ACROINNOVA 1 and ACROINNOVA 2. In the placebo-controlled ACROINNOVA 1 study, a significantly higher proportion of patients on Oczyesa achieved normalized IGF-1 levels compared to placebo. ACROINNOVA 2 confirmed sustained IGF-1 normalization, reduced symptoms and improved quality of life over 52 weeks, and patients reported higher treatment satisfaction than with their previous standard-of-care treatment. The safety profile was comparable to established somatostatin receptor ligands.^2,3

The product has previously been granted marketing authorization in the EU, the UK and Australia under the brand name Oczyesa^®.

For more information
Fredrik Tiberg, President & CEO
Tel. +46 (0)46 286 46 92
fredrik.tiberg@camurus.com

Fredrik Joabsson, Chief Business Development Officer
Tel. +46 (0)70 776 17 37
ir@camurus.com

About acromegaly
Acromegaly is a rare, slowly progressive disease, typically caused by a tumor of the pituitary gland producing excess growth hormone and stimulating increased insulin growth factor-1 (IGF-1) levels. This results in abnormal growth of bone and tissue, enlarged hands, feet, facial features and inner organs, and symptoms such as fatigue, joint pain, headache, visual field defects, excessive sweating, and paresthesia.⁴ Inadequate biochemical and symptom control can have detrimental impacts on quality of life and mortality of patients with acromegaly.^5,6 The prevalence of acromegaly is estimated to about 60 cases per million.⁷

About Oczyesa^® (CAM2029)
Oczyesa (CAM2029) is a ready-to-use, long-acting subcutaneous depot of octreotide indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogs.¹ The product is stored at room temperature and should not be refrigerated.

The CAM2029 clinical program for acromegaly comprises seven clinical trials, including four Phase 1 studies, one Phase 2 study, and two Phase 3 studies within the ACROINNOVA clinical program. CAM2029 has demonstrated an approximate five-fold higher bioavailability compared to the currently approved, long-acting, intramuscular (IM) octreotide.⁸ The ACROINNOVA 1 study demonstrated that treatment with Oczyesa results in a significantly higher proportion of patients achieving normalized insulin growth-factor-1 (IGF-1) levels compared to placebo. The persistence of mean IGF-1 values and reduction of symptoms were confirmed over 52 weeks in the ACROINNOVA 2 study. Furthermore, the study showed improvements in symptoms, quality of life, and treatment satisfaction scores after 52 weeks of treatment with Oczyesa compared to standard of care (SoC) at baseline. The treatment was well tolerated, with a safety profile consistent with standard of care with first-generation SRLs.^2,3

CAM2029 (Oczyesa) was granted marketing authorization for acromegaly in the EU by the European Commission in June 2025, in the UK by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in August 2025, and in Australia by the Australian TGA in August 2026.

CAM2029 is under development for two additional chronic and severe disease indications: gastroenteropancreatic neuroendocrine tumors (GEP-NET) and polycystic liver disease (PLD).

About Camurus
Camurus is an international, science-led biopharmaceutical company committed to developing and commercializing innovative, long-acting medicines for improving the lives of patients with severe and chronic diseases. New drug products with best-in-class potential are conceived based on the company's proprietary FluidCrystal^® technology and its extensive R&D expertise. The R&D pipeline includes products for the treatment of dependence, pain, cancer, and endocrine diseases. Camurus has operations across Europe, the US, and Australia, with headquarters in Lund, Sweden. The company's shares are listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit www.camurus.com and LinkedIn.

References

1. Oczyesa^® XR Product Monograph.
2. Ferone, D., et al. J Clin Endocrinol Metab. Published 8 October, 2024.
3. Press release 15 July, 2024: 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/  
4. Colao A., et al. Acromegaly. Nat Rev Dis Primers. 2019;5(1):20.
5. Webb SM, et al. Quality of Life in Acromegaly. Neuroendocrinology. 2016;103(1):106-111.
6. Fleseriu M., et al Acromegaly: pathogenesis, diagnosis, and management. Lancet Diabetes Endocrinol. 2022 Nov;10(11):804-826.
7. Crisafulli S., et al. Global epidemiology of acromegaly: a systematic review and meta-analysis. Eur J Endocrinology. 2021; 185:251-63.
8. Summary of Product Characteristics, Sandostatin LAR 20 mg: https://assets.hpra.ie/products/Human/22656/Licence_PA0896-028-005_03012024152159.pdf

This information was submitted for publication at 9.00 am CET on 12 October 2026.