Camurus' NDA resubmission for CAM2029 in acromegaly accepted for review by the US FDA

Rhea-AI Summary

Camurus (NASDAQ STO: CAMX) reports that the US FDA has accepted for review the resubmitted New Drug Application (NDA) for CAM2029, an octreotide extended-release injection for acromegaly. The FDA has set a PDUFA target action date of 18 December 2026.

The resubmission follows a Complete Response Letter (CRL) on 10 June 2026, which was related to cGMP inspection observations at a third-party manufacturer and, according to Camurus, did not raise concerns about CAM2029’s clinical efficacy or safety. The contract manufacturer has implemented remediation actions and confirmed inspection readiness.

CAM2029 is an investigational, once-monthly, subcutaneous long-acting octreotide depot using Camurus’ FluidCrystal technology, designed for self-administration via autoinjector pen. The NDA is supported by seven clinical studies, including two Phase 3 trials in the ACROINNOVA program. According to Camurus, CAM2029 already has marketing authorization for acromegaly in the EU and UK as Oczyesa, and additional applications are under review in two other countries.

Positive

• FDA accepts resubmitted NDA for CAM2029 with PDUFA date 18 December 2026
• CRL limited to cGMP inspection issues, with no efficacy or safety concerns reported
• Seven clinical studies, including two Phase 3 ACROINNOVA trials, support the NDA
• Existing marketing authorizations for CAM2029 (Oczyesa) in EU and UK for acromegaly

Negative

• Complete Response Letter issued 10 June 2026 tied to third-party cGMP inspection observations
• Regulatory outcome in US remains pending until at least the 18 December 2026 PDUFA date
• Dependence on third-party manufacturer’s compliance highlighted by prior inspection findings

News Market Reaction – CAMX

-0.62%

-0.62% Session close to close

In the Jul 17 session, CAMX declined 0.62%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

Set against a prior collaboration headline that produced only a modest negative move and with report...

Analysis

Set against a prior collaboration headline that produced only a modest negative move and with reported short interest very low, this FDA review milestone may initially be treated cautiously. Investors could watch how quickly any remaining manufacturing or inspection issues appear resolved as the 18 December 2026 PDUFA date approaches.

Key Figures

PDUFA target action date: 18 December 2026 CRL issue date: 10 June 2026 Clinical studies: 7 studies +3 more

6 metrics

PDUFA target action date 18 December 2026 FDA review timeline for CAM2029 NDA resubmission in acromegaly

CRL issue date 10 June 2026 FDA Complete Response Letter related to cGMP inspection

Clinical studies 7 studies Total studies supporting CAM2029 NDA

Phase 3 studies 2 Phase 3 studies ACROINNOVA program supporting CAM2029 NDA

Dosing frequency Once-monthly CAM2029 subcutaneous long-acting octreotide depot regimen

Additional countries under review 2 countries Marketing authorization applications for CAM2029 beyond EU and UK

Historical Context

1 past event · Latest: Jun 01 (Positive)

Pattern 1 events

Date	Event	Sentiment	24h Move	Catalyst
Jun 01	Collaboration expansion	Positive	-0.4%	Eli Lilly expanded FluidCrystal collaboration with sizable milestone and royalty economics.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

With limited history, the last major collaboration expansion headline saw a small negative price reaction despite seemingly positive deal terms.

Key Terms

pdufa, new drug application, complete response letter, cgmp, +1 more

5 terms

pdufa regulatory

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

PDUFA is the Prescription Drug User Fee Act, the U.S. law under which drug companies pay fees that fund the FDA's review of new medicines. In company news the term usually appears as the PDUFA date, the target deadline by which the FDA aims to decide on a drug application; that date tells investors when to expect the approval or rejection decision for the product.

new drug application regulatory

"accepted for review the resubmission of the New Drug Application (NDA) for CAM2029"

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

complete response letter regulatory

"follows the Complete Response Letter (CRL) issued by the FDA on 10 June 2026"

A complete response letter is an official communication from a drug or medical-device regulator, such as the U.S. Food and Drug Administration (FDA), telling a company that a marketing application cannot be approved in its current form and listing the specific deficiencies to be fixed. For investors it matters because it pauses or delays a product’s path to market—like a building inspector issuing a list of repairs before a certificate of occupancy—affecting revenue timing, costs and stock value.

cgmp technical

"related to observations from a cGMP inspection at a third-party manufacturer"

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.

marketing authorization regulatory

"CAM2029 has been granted marketing authorization for acromegaly in the European Union"

An official government approval that allows a drug, vaccine, or medical device to be sold and promoted in a specific country or region. Think of it as a safety and effectiveness passport issued after regulators review the product’s tests and manufacturing; for investors, receiving this authorization typically unlocks sales, revenue potential, and lower regulatory risk, while delays or denials can substantially affect a company’s value and timeline.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

PDUFA target action date set to 18 December 2026

LUND, Sweden, July 17, 2026 /PRNewswire/ -- Camurus (NASDAQ STO: CAMX) today announced 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, for the treatment of patients with acromegaly. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of 18 December 2026.

The resubmission follows the Complete Response Letter (CRL) issued by the FDA on 10 June 2026, which related to observations from a cGMP inspection at a third-party manufacturer. The CRL did not raise any concern regarding the clinical efficacy or safety of CAM2029. The contract manufacturer has implemented all remediation actions and has confirmed inspection readiness.

"We look forward to continuing the collaboration with the FDA to make CAM2029 available to patients with acromegaly in the United States", says Fredrik Tiberg, President & CEO, Camurus.

CAM2029 is an investigational, subcutaneous long-acting octreotide depot based on Camurus' proprietary FluidCrystal^® technology, designed for once-monthly self-administration via an autoinjector pen. The NDA is supported by data from seven clinical studies, including two Phase 3 studies in the ACROINNOVA program.

CAM2029 has been granted marketing authorization for acromegaly in the European Union and the United Kingdom under the product name Oczyesa^®1. In addition, marketing authorization applications are under review in two additional countries.

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.^3,4The prevalence of acromegaly is estimated to about 60 cases per million.⁴

About CAM2029

CAM2029, octreotide SC depot, is approved for the treatment of patients with acromegaly in the EU and the UK under the brand name Oczyesa^®, and in registration phase in the US and two additional markets. Additionally, CAM2029 is under development for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NET), and polycystic liver disease (PLD). CAM2029 is designed for enhanced octreotide exposure and convenient, once-monthly administration with a prefilled autoinjector pen to facilitate easy self-administration by patients.

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.⁵ In the Phase 3 ACROINNOVA program, CAM2029 showed superior biochemical control compared to placebo as well as improvements in symptom control, treatment satisfaction, and quality of life compared to standard of care (SoC) at baseline with first-generation somatostatin receptor ligands (SRLs), octreotide and lanreotide. The safety profile of CAM2029 was consistent with SoC with no new findings.^6,7

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. Giustina A., et al. Acromegaly. N Engl J Med. 2025 Nov 13;393(19):1926-1939.
3. Webb SM, et al. Quality of Life in Acromegaly. Neuroendocrinology. 2016;103(1):106-111.
4. 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.
5. Prescribing Information SANDOSTATIN^® LAR
6. 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
7. 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.

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

https://news.cision.com/camurus-ab/r/camurus--nda-resubmission-for-cam2029-in-acromegaly-accepted-for-review-by-the-us-fda,c4375617

The following files are available for download:

https://mb.cision.com/Main/13456/4375617/4197346.pdf

260717 Camurus’ NDA resubmission for CAM2029 in acromegaly accepted for review by the US FDA

 

View original content:https://www.prnewswire.com/news-releases/camurus-nda-resubmission-for-cam2029-in-acromegaly-accepted-for-review-by-the-us-fda-302828300.html

SOURCE Camurus AB

FAQ

What did Camurus (CAMX) announce about the CAM2029 NDA on 17 July 2026?

Camurus announced that the US FDA accepted the resubmitted NDA for CAM2029 in acromegaly. According to Camurus, the agency set a PDUFA target action date of 18 December 2026, restarting the formal US regulatory review process.

What is the FDA PDUFA target action date for Camurus CAM2029 NDA (CAMX)?

The FDA’s PDUFA target action date for CAM2029 is 18 December 2026. According to Camurus, this date marks when the FDA aims to complete its review of the resubmitted NDA for octreotide extended-release injection in acromegaly.

Why did the FDA issue a Complete Response Letter for Camurus CAM2029 in June 2026?

The FDA’s June 10, 2026 Complete Response Letter related to cGMP inspection observations at a third-party manufacturer. According to Camurus, the CRL did not raise any concerns regarding the clinical efficacy or safety of CAM2029 in acromegaly.

How has Camurus addressed the manufacturing issues mentioned in the CAM2029 CRL?

Camurus reports that the contract manufacturer implemented all remediation actions addressing cGMP observations. According to Camurus, the manufacturer has also confirmed inspection readiness, supporting the FDA’s acceptance of the CAM2029 NDA resubmission for review in acromegaly.

What clinical data support the CAM2029 NDA for acromegaly from Camurus (CAMX)?

The CAM2029 NDA is supported by data from seven clinical studies, including two Phase 3 ACROINNOVA trials. According to Camurus, these studies evaluated CAM2029, a long-acting subcutaneous octreotide depot designed for once-monthly self-administration via an autoinjector pen.

Is Camurus CAM2029 (Oczyesa) already approved outside the United States?

Yes, CAM2029 has marketing authorization for acromegaly in the EU and UK under the name Oczyesa. According to Camurus, marketing authorization applications are also under review in two additional countries beyond these existing approvals.

What is CAM2029 from Camurus and how is it administered for acromegaly?

CAM2029 is an investigational long-acting octreotide depot using FluidCrystal technology, designed for acromegaly treatment. According to Camurus, it is formulated for once-monthly, subcutaneous self-administration via an autoinjector pen, aiming to offer a convenient treatment option.