PDUFA target action date set to 18 December 2026

/PRNewswire/ - Camurus (NASDAQ STO: CAMX) announced today that the US Food and Drug Administration (FDA) has accepted for review the resubmission of the New Drug Application (NDA) for CAM2029, octreotide extended-release injection, indicated for acromegaly treatment. The FDA set a Prescription Drug User Fee Act (PDUFA) target action date of 18 December 2026.

The resubmission comes after the FDA issued a Complete Response Letter (CRL) on 10 June 2026 concerning observations from a cGMP inspection at a third-party manufacturer. The CRL raised no issues about the clinical efficacy or safety profile of CAM2029. The contract manufacturer completed all remediation steps and confirmed readiness for inspection.

"We look forward to ongoing collaboration with the FDA to bring CAM2029 to patients with acromegaly in the United States," said Fredrik Tiberg, President and CEO of Camurus.

CAM2029 is an investigational subcutaneous long-acting octreotide depot using Camurus proprietary FluidCrystal technology for once-monthly self-administration through an autoinjector pen. The NDA draws on data from seven clinical studies, including two Phase 3 trials in the ACROINNOVA program.

CAM2029 received marketing authorization for acromegaly in the European Union and the United Kingdom under the name Oczyesa. 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 is a rare, slowly progressive disease usually caused by a pituitary gland tumor that produces excess growth hormone and raises insulin growth factor-1 (IGF-1) levels. This leads to abnormal bone and tissue growth, enlarged hands, feet, facial features and internal organs, along with symptoms such as fatigue, joint pain, headache, visual field defects, excessive sweating and paresthesia.² Poor biochemical and symptom control can negatively affect quality of life and mortality in acromegaly patients.^3,4The estimated prevalence is about 60 cases per million.⁴

About CAM2029

CAM2029, octreotide SC depot, is approved for acromegaly treatment in the EU and UK under the brand name Oczyesa, and is in the registration phase in the US and two additional markets. CAM2029 is also under development for gastroenteropancreatic neuroendocrine tumors (GEP-NET) and polycystic liver disease (PLD). It offers enhanced octreotide exposure and convenient once-monthly dosing via a prefilled autoinjector pen for easy patient self-administration.

The CAM2029 acromegaly clinical program includes seven trials: four Phase 1 studies, one Phase 2 study and two Phase 3 studies in the ACROINNOVA program. CAM2029 showed roughly five-fold higher bioavailability than the currently approved long-acting intramuscular octreotide.⁵ In the Phase 3 ACROINNOVA program, CAM2029 delivered superior biochemical control versus placebo and improved symptom control, treatment satisfaction and quality of life compared with standard of care using first-generation somatostatin receptor ligands at baseline. The safety profile matched standard of care with no new signals.^6,7

About Camurus

Camurus is an international science-led biopharmaceutical company focused on developing and commercializing innovative long-acting medicines to improve outcomes for patients with severe and chronic conditions. New products with best-in-class potential are developed using the company's proprietary FluidCrystal technology and extensive R&D expertise. The pipeline covers treatments for dependence, pain, cancer and endocrine diseases. Camurus operates across Europe, the US and Australia, with headquarters in Lund, Sweden. Shares are listed on Nasdaq Stockholm under 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 is information that Camurus AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the managing director, at 7:00 am CET on 17 July 2026.

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