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Camurus AB (CAMX) is frequently featured in news coverage related to long-acting biopharmaceutical therapies built on its proprietary FluidCrystal technology. Company announcements focus on clinical trial results, regulatory milestones, product approvals, and strategic collaborations across therapeutic areas such as opioid dependence, acromegaly, polycystic liver disease, obesity, and cardiometabolic health.
News about Camurus often highlights developments for its octreotide subcutaneous depot program, known as CAM2029 and marketed as Oczyesa in the EU and as Oclaiz in US regulatory filings. Coverage includes Phase 3 data from the ACROINNOVA studies in acromegaly, the POSITANO Phase 2b trial in polycystic liver disease, and regulatory steps such as European marketing authorization and FDA review of a resubmitted New Drug Application.
Another recurring theme in CAMX news is the company’s work in opioid dependence and opioid use disorder through its buprenorphine depot products Buvidal and Brixadi. Articles report on FDA approval of Brixadi in the US, clinical data comparing weekly and monthly depot injections to daily sublingual buprenorphine/naloxone, and analyses of effectiveness in individuals using fentanyl.
Investors and observers can also find updates on emerging programs such as CAM2056, a long-acting semaglutide depot for overweight and obesity, and on business agreements, including a collaboration and license deal with Eli Lilly for long-acting incretin products for cardiometabolic health. This news page aggregates these regulatory, clinical, and partnership developments so readers can follow how Camurus’ pipeline and approved products evolve over time.
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.
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