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Camurus (CAMX) develops and commercializes long-acting medicines for severe and chronic diseases using its proprietary FluidCrystal® technology. Recurring news covers endocrine, dependence, pain, cancer and cardiometabolic programs, including Oczyesa®/CAM2029 octreotide depot for acromegaly and CAM2056, a monthly subcutaneous semaglutide formulation.
Company updates also include clinical-study results, regulatory submissions and authorizations, product-launch activity, and collaboration or license agreements tied to long-acting injectable therapies. Camurus reports operations across Europe, the United States and Australia, with shares listed on Nasdaq Stockholm under the ticker CAMX.
Camurus (NASDAQ STO: CAMX) announced that Eli Lilly has exercised its option to add amylin receptor agonists to their existing 2025 collaboration and license agreement using Camurus' FluidCrystal® technology.
The deal now covers up to four Lilly compounds and includes up to 290 million USD in development and regulatory milestones, 580 million USD in sales-based milestones, tiered mid-single digit royalties, and a 5 million USD option payment.
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.
Camurus (NASDAQ: CAMX) reported positive topline Phase 1b results for CAM2056, a monthly FluidCrystal semaglutide depot, in 80 participants with overweight or obesity on Nov 10, 2025. CAM2056 delivered dose-dependent reductions in body weight, A1c and fasting glucose that were comparable to or exceeded weekly semaglutide to Day 85.
Key data: weight -9.3% for CAM2056 10 mg vs -5.2% for weekly semaglutide (treatment diff -4.1%, p=0.008); A1c -0.44% for CAM2056 with treatment diff -0.32% (p<0.001). Safety was generally consistent with weekly semaglutide, though the highest initiation cohort had more frequent/severe events. A Phase 2b study is planned.
Camurus (NASDAQ STO: CAMX) has received European Commission marketing authorization for Oczyesa®, a first-of-its-kind subcutaneous, once-monthly octreotide treatment for adult patients with acromegaly who have responded to and tolerated somatostatin analog treatment.
The approval is supported by a comprehensive clinical program including seven clinical studies, with two Phase 3 trials. The ACROINNOVA 1 study showed significantly higher normalization of insulin growth-factor-1 (IGF-1) levels compared to placebo, while ACROINNOVA 2 demonstrated sustained IGF-1 control and symptom reduction over 52 weeks versus standard of care.
Oczyesa® utilizes Camurus' FluidCrystal® technology and is designed for self-administration through a pre-filled autoinjector pen. The treatment addresses a market of approximately 70,000 patients living with acromegaly in the EU.
Camurus (NASDAQ STO: CAMX) has received a positive recommendation from the European Medicines Agency's CHMP for market authorization of Oczyesa®, a monthly octreotide depot treatment for adult acromegaly patients. The recommendation is supported by comprehensive clinical data from seven studies, including two Phase 3 trials.
The ACROINNOVA 1 study showed Oczyesa achieved higher normalization rates of insulin growth-factor-1 (IGF-1) levels versus placebo. ACROINNOVA 2 confirmed sustained IGF-1 improvements and demonstrated enhanced symptoms, quality of life, and treatment satisfaction over 52 weeks compared to standard care. Common side effects included gastrointestinal, nervous system, and hepatobiliary disorders.
A final European Commission decision on marketing authorization is expected in mid-2025.
Camurus (NASDAQ: CAMX) announced positive final results from the 52-week Phase 3 ACROINNOVA 2 study of octreotide SC depot (CAM2029) in acromegaly patients. The study met its primary safety endpoint, showing a profile consistent with standard-of-care. Key findings include:
1. Increased biochemical response rates vs. baseline
2. Continuous improvement in acromegaly symptoms and quality of life
3. Well-tolerated treatment with no new safety signals
The study included 135 patients, with 81 new and 54 roll-over patients. Results showed a 12.7% increase in treatment response rates overall, and 22.8% in new patients. Regulatory reviews are ongoing in the US and EU, with an FDA decision expected by October 21, 2024.
Camurus has announced a new publication in JAMA Network Open, detailing a post hoc analysis from a 24-week Phase 3 study comparing weekly and monthly subcutaneous buprenorphine injections (Buvidal®/Brixadi®) to daily sublingual buprenorphine/naloxone. The study involved 428 participants, with 123 showing baseline fentanyl use. Results showed that the mean percentage of fentanyl-negative urine samples was higher in the SC-BPN group (74%) compared to the SL-BPN/NX group (61.9%). Withdrawal symptoms and cravings decreased in fentanyl-positive patients following treatment initiation. Safety profiles were consistent with known data, with mild to moderate injection site reactions observed. The publication underscores the effectiveness of extended-release buprenorphine in treating opioid dependence even in patients using fentanyl.
Summary not available.