Camurus announces FDA acceptance of NDA resubmission for Oclaiz™ for the treatment of acromegaly

Rhea-AI Summary

Camurus (NASDAQ STO: CAMX) announced the FDA accepted the resubmission of the NDA for Oclaiz™ (CAM2029) for acromegaly and set a PDUFA target action date of 10 June 2026. The updated NDA was submitted on 10 December 2025 and is supported by data from seven clinical studies, including two Phase 3 ACROINNOVA trials. The earlier Complete Response Letter related solely to observations from a cGMP inspection at a third‑party manufacturer. Oclaiz is a monthly, subcutaneous, long‑acting octreotide depot using FluidCrystal® technology and has received EU and UK marketing authorization in 2025.

Positive

• FDA accepted NDA resubmission and set PDUFA date 10 June 2026
• NDA supported by seven clinical studies including two Phase 3 trials
• Oclaiz is once‑monthly, subcutaneous, self‑administered via autoinjector
• Oclaiz received EU and UK marketing authorization in 2025

Negative

• Previous CRL was issued due to cGMP inspection observations at a contract manufacturer
• Manufacturing observations at third‑party site could affect US approval timing

News Market Reaction – CAMX

+0.47%

1 alert

+0.47% News Effect

On the day this news was published, CAMX gained 0.47%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

PDUFA target date: 10 June 2026 NDA resubmission date: 10 December 2025 Supporting studies: 7 clinical studies +5 more

8 metrics

PDUFA target date 10 June 2026 FDA review timeline for Oclaiz NDA resubmission

NDA resubmission date 10 December 2025 Updated NDA submitted to FDA after prior CRL

Supporting studies 7 clinical studies Includes two Phase 3 studies in ACROINNOVA program for Oclaiz

Phase 3 studies 2 Phase 3 studies Part of ACROINNOVA program supporting Oclaiz NDA

CAM2056 sample size 80 participants Phase 1b trial in overweight or obesity (Nov 10, 2025 news)

Weight change CAM2056 -9.3% CAM2056 10 mg body weight reduction to Day 85

Weight change weekly semaglutide -5.2% Comparator arm body weight reduction to Day 85

Current share price $32.82 Pre-news price, <b>-0.14%</b> vs 52-week high, <b>24.08%</b> above 52-week low

Market Reality Check

Price: $32.01 Vol: Volume 150 vs 20-day aver...

low vol

$32.01 Last Close

Volume Volume 150 vs 20-day average 2,007 (relative volume 0.07x) shows limited pre-news activity. low

Technical Price 32.82 is trading above 200-day MA at 30.87, near the 52-week high of 32.8655.

Historical Context

1 past event · Latest: Nov 10 (Positive)

Pattern 1 events

Date	Event	Sentiment	Move	Catalyst
Nov 10	Clinical data update	Positive	+0.3%	Positive Phase 1b topline results for CAM2056 in 80 participants.

Pattern Detected

Limited history shows a modestly positive price reaction to favorable clinical data.

Recent Company History

This announcement reports FDA acceptance of Camurus’ NDA resubmission for Oclaiz, with a PDUFA target action date of 10 June 2026. Recently, on Nov 10, 2025, Camurus released positive Phase 1b topline results for CAM2056 in 80 participants with overweight or obesity, which saw a modest 0.3% 24-hour price gain. Together, these updates highlight ongoing U.S. regulatory progress for Oclaiz and earlier-stage pipeline advancement for CAM2056, underscoring Camurus’ focus on long-acting depot formulations.

Market Pulse Summary

This announcement confirms FDA acceptance of Camurus’ NDA resubmission for Oclaiz, with a PDUFA targ...

Analysis

This announcement confirms FDA acceptance of Camurus’ NDA resubmission for Oclaiz, with a PDUFA target action date of 10 June 2026. The filing is backed by seven clinical studies, including two Phase 3 trials, and follows a Complete Response Letter related to third-party manufacturing inspections. Investors may track progress toward the PDUFA decision and uptake of Oclaiz in the EU and UK, alongside ongoing pipeline developments such as CAM2056.

Key Terms

pdufa, nda, acromegaly, subcutaneous, +4 more

8 terms

pdufa regulatory

"The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date"

PDUFA, short for the Prescription Drug User Fee Act, is a law that allows drug companies to pay fees to the government to speed up the review process for new medicines. This helps bring important drugs to market more quickly, which can impact their availability and pricing. For investors, PDUFA timelines can influence the timing of a drug’s approval and potential market success.

nda regulatory

"accepted for review the company's resubmission of the New Drug Application (NDA) for Oclaiz"

An NDA, or nondisclosure agreement, is a legal contract that keeps certain information private between parties. It’s like a promise not to share sensitive details, helping protect business ideas, strategies, or data from being leaked or used without permission. For investors, NDAs help ensure that confidential information remains secure, enabling trust and open communication during business discussions.

acromegaly medical

"for the treatment of patients with acromegaly."

Acromegaly is a rare hormonal disorder in adults caused when the body makes too much growth hormone, usually because of a noncancerous pituitary tumor, leading to gradual enlargement of the hands, feet and facial features and other health problems. For investors, it matters because it creates a defined market for diagnostics, long‑term therapies and surgical or drug innovations; understanding its prevalence and treatment options helps assess potential revenue and regulatory risk for healthcare companies.

subcutaneous medical

"Oclaiz is a subcutaneous long-acting octreotid depot, designed for optimized disease control"

Subcutaneous means situated or applied just beneath the skin. In finance, the term can describe processes or investments that are hidden or not immediately visible, much like something placed under the skin that isn't easily seen from the outside. Recognizing subcutaneous activities helps investors understand underlying factors that may influence markets or asset values over time.

autoinjector pen technical

"administrated once monthly with an autoinjector pen."

A autoinjector pen is a handheld, spring-loaded device that automatically delivers a fixed dose of medication through the skin, making injections quicker and easier for patients than using a syringe. For investors, autoinjectors matter because they can expand patient access, drive repeat sales, and command higher prices, while also carrying regulatory, manufacturing and product-safety risks that can affect a drug’s market success and a maker’s revenue predictability.

phase 3 medical

"including two Phase 3 studies in the ACROINNOVA program."

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

cGMP regulatory

"related to observations during a cGMP inspection at a third-party manufacturer's facility."

cGMP (current Good Manufacturing Practice) are government-enforced quality standards that manufacturers must follow to ensure drugs, medical devices, and related products are made consistently, safely, and meet specified quality tests. For investors, cGMP compliance is like a restaurant passing health inspections: it reduces the risk of product recalls, regulatory fines, or production stoppages that can hurt revenue and company value, and it supports market access and long-term trust.

a1c medical

"A1c -0.44% for CAM2056 with treatment diff -0.32% (p<0.001)."

A1C is a blood test that reports average blood sugar over about three months by measuring how much glucose sticks to hemoglobin, a protein in red blood cells. For investors, A1C acts like a long-term scorecard for diabetes treatments, devices and diagnostics: meaningful changes in A1C in clinical studies can affect regulatory approval, insurance coverage and commercial prospects, and thus influence a company's market value.

AI-generated analysis. Not financial advice.

PDUFA target action date set to 10 June 2026

LUND, Sweden, Jan. 9, 2026 /PRNewswire/ -- Camurus (NASDAQ STO: CAMX) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's resubmission of the New Drug Application (NDA) for Oclaiz™ (CAM2029), octreotide extended-release injection, for the treatment of patients with acromegaly. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of 10 June 2026.

"We look forward to the continued collaboration with the FDA to make Oclaiz available to patients with acromegaly in the US as soon as possible," says Fredrik Tiberg, President & CEO, Camurus.

Oclaiz is a subcutaneous long-acting octreotid depot, designed for optimized disease control and convenient self-administration. The product is based on Camurus' FluidCrystal^® technology and is administrated once monthly with an autoinjector pen.  

The application is supported by data from seven clinical studies, including two Phase 3 studies in the ACROINNOVA program. The updated NDA was submitted to the FDA on 10 December 2025 following a Complete Response Letter (CRL) earlier issued by the Agency, which solely related to observations during a cGMP inspection at a third-party manufacturer's facility.  

The product received marketing authorization in the EU and UK in 2025 under the product name Oczyesa^®.¹ The product launch has recently been initiated in the EU.

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.² Inadequate biochemical and symptom control can have detrimental impacts on quality of life and mortality of patients with acromegaly.^3,4 The prevalence of acromegaly is estimated to about 60 cases per million.⁵

About Oclaiz™ (CAM2029)

CAM2029 is a ready-to-use octreotide for subcutaneous administration formulated using Camurus' proprietary FluidCrystal^® technology. The product is designed for convenient, monthly subcutaneous self-administration using a pre-filled autoinjector pen with a hidden, thin needle.

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.⁶ The ACROINNOVA 1 study demonstrated that treatment with CAM2029 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 reduced disease symptoms, improved quality of life, and treatment satisfaction scores after 52 weeks of treatment with CAM2029 compared to standard of care (SoC) at baseline. The most common side effects included gastrointestinal disorders, nervous system disorders, hepatobiliary disorders, metabolism and nutritional disorders, and injection site reactions.^7,8

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. SmPC Oczyesa^®
2. Colao A., et al. Acromegaly. Nat Rev Dis Primers. 2019;5(1):20.
3. Webb SM, et al. Quality of Life in Acromegaly. Neuroendocrinology. 2016;103(1):106-111.
4. Fleseriu M, et al Acromegaly: pathogenesis, diagnosis, and management. Lancet Diabetes Endocrinol. 2022 Nov;10(11):804-826.
5. Crisafulli S., et al. Global epidemiology of acromegaly: a systematic review and meta-analysis. Eur J Endocrinology. 2021; 185:251-63.
6. Prescribing Information SANDOSTATIN^® LAR  
7. 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. https://doi.org/10.1210/clinem/dgae707
8. Pressmeddelande 15 juli 2024: https://www.camurus.com/sv/media/pressmeddelanden/2024/camurus-meddelar-positiva-fas-3-resultat-fran-acroinnova-2-studien-av-oktreotid-subkutan-depa-cam2029-i-patienter-med-akromegali/

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 3:10 pm CET on 9 January 2026.

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/camurus-ab/r/camurus-announces-fda-acceptance-of-nda-resubmission-for-oclaiz--for-the-treatment-of-acromegaly,c4290495

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Press release

 

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SOURCE Camurus AB

FAQ

What did Camurus (CAMX) announce on January 9, 2026 about Oclaiz NDA?

The company said the FDA accepted the NDA resubmission for Oclaiz and set a PDUFA date of 10 June 2026.

When was the updated Oclaiz NDA submitted to the FDA by CAMX?

The updated NDA was submitted on 10 December 2025.

What clinical evidence supports the CAMX Oclaiz NDA for acromegaly?

The application is supported by data from seven clinical studies, including two Phase 3 ACROINNOVA trials.

Did Oclaiz face regulatory issues before the FDA acceptance for CAMX?

Yes; a previous Complete Response Letter related solely to cGMP inspection observations at a third‑party manufacturer.

Has Oclaiz been authorized outside the US for CAMX shareholders to note?

Yes; Oclaiz received marketing authorization in the EU and UK in 2025 under the name Oczyesa.

How is Oclaiz administered and how often for patients with acromegaly?

Oclaiz is a long‑acting subcutaneous octreotide depot administered once monthly with an autoinjector pen.