PDUFA target action date set for 18 December 2026

Camurus (NASDAQ STO: CAMX) confirms that the US Food and Drug Administration has agreed to review the resubmitted New Drug Application for CAM2029, an octreotide extended-release injection developed for acromegaly treatment. The agency has established a Prescription Drug User Fee Act target action date of 18 December 2026.

This resubmission responds to the Complete Response Letter issued by the FDA on 10 June 2026 concerning observations from a cGMP inspection at a third-party manufacturing site. The letter raised no issues related to the clinical efficacy or safety profile of CAM2029. The contract manufacturer has completed all required remediation steps and verified inspection readiness.

"We anticipate productive ongoing engagement with the FDA to bring CAM2029 to patients with acromegaly across the United States," states Fredrik Tiberg, President and CEO of Camurus.

CAM2029 represents an investigational subcutaneous long-acting octreotide depot formulated with Camurus proprietary FluidCrystal technology and intended for convenient once-monthly self-administration through an autoinjector pen. The NDA draws on results from seven clinical trials, among them two Phase 3 studies conducted under the ACROINNOVA program.

CAM2029 already holds marketing authorization for acromegaly in the European Union and the United Kingdom, where it is marketed as Oczyesa. Additional marketing authorization applications remain under review in two further countries.

For more information
Fredrik Tiberg, President and 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
fredrik.joabsson@camurus.com

About acromegaly

Acromegaly constitutes a rare, gradually advancing disorder most often triggered by a pituitary tumor that overproduces growth hormone and elevates insulin-like growth factor-1 levels. The condition leads to excessive bone and tissue enlargement affecting hands, feet, facial structures and internal organs, accompanied by fatigue, joint discomfort, headaches, visual disturbances, profuse sweating and paresthesia. Insufficient biochemical and symptom management can adversely influence patient quality of life and survival rates. Prevalence estimates indicate roughly 60 cases per million individuals.

About CAM2029

CAM2029, the octreotide subcutaneous depot, has received approval for acromegaly in the EU and UK under the Oczyesa brand and is progressing through registration in the US and two additional markets. Development continues for gastroenteropancreatic neuroendocrine tumors and polycystic liver disease. The product employs FluidCrystal technology to achieve higher octreotide exposure and supports straightforward monthly dosing via a prefilled autoinjector pen that enables patient self-administration.

The CAM2029 acromegaly clinical program encompasses seven trials, including four Phase 1 studies, one Phase 2 study and two Phase 3 trials within the ACROINNOVA series. CAM2029 has shown approximately five-fold greater bioavailability versus currently approved long-acting intramuscular octreotide formulations. Phase 3 results demonstrated superior biochemical control over placebo together with gains in symptom management, treatment satisfaction and quality of life relative to baseline standard-of-care first-generation somatostatin receptor ligands. The safety profile aligned with existing therapies and revealed no novel signals.

About Camurus

Camurus operates as an international science-driven biopharmaceutical company focused on creating and commercializing innovative long-acting medicines that enhance outcomes for patients living with serious chronic conditions. Pipeline candidates with best-in-class potential originate from the company's FluidCrystal technology platform and deep research expertise. Development programs address dependence, pain, cancer and endocrine disorders. Camurus maintains presence throughout Europe, the US and Australia, with headquarters located in Lund, Sweden. Shares trade on Nasdaq Stockholm under the ticker CAMX.

References

SmPC Oczyesa
Giustina A., et al. Acromegaly. N Engl J Med. 2025 Nov 13;393(19):1926-1939.
Webb SM, et al. Quality of Life in Acromegaly. Neuroendocrinology. 2016;103(1):106-111.
Crisafulli S., et al. Global epidemiology of acromegaly: a systematic review and meta-analysis. Eur J Endocrinology. 2021; 185:251-63. Colao A., et al. Acromegaly. Nat Rev Dis Primers. 2019;5(1):20.
Prescribing Information SANDOSTATIN LAR
Ferone, D., et al. Octreotide subcutaneous depot for acromegaly: A randomized, double-blind, placebo-controlled phase 3 trial, ACROINNOVA 1. J Clin Endocrinol Metab. Published 8 October, 2024.
Press release 15 July, 2024

This information constitutes material that Camurus AB must disclose under the EU Market Abuse Regulation. The details were released for publication by the managing director at 7:00 am CET on 17 July 2026.

SOURCE Camurus AB