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About Cumberland Pharmaceuticals Inc.
Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) is a specialty pharmaceutical company dedicated to the acquisition, development, and commercialization of branded prescription pharmaceutical products. Headquartered in Nashville, Tennessee, Cumberland is the largest biopharmaceutical company founded in the state and focuses on delivering high-quality products that address unmet medical needs. The company operates primarily in the hospital acute care, gastroenterology, rheumatology, and oncology market segments, targeting underserved physician groups and patient populations.
Core Business Model and Operations
Cumberland's business model is built on three key pillars:
- Acquisition: The company strategically acquires FDA-approved products and late-stage development assets that align with its therapeutic focus.
- Development: Cumberland invests in clinical trials and regulatory processes to enhance its product portfolio, including expanding indications and improving formulations.
- Commercialization: The company markets its products through specialized hospital, field, and oncology sales teams in the United States, while leveraging a network of international partners to distribute its medicines globally.
The company derives its revenue primarily from the sales of FDA-approved pharmaceutical brands, including Acetadote®, Caldolor®, Kristalose®, Omeclamox®-Pak, Sancuso®, Vaprisol®, and Vibativ®. These products address critical medical needs such as pain management, gastrointestinal disorders, oncology support, and treatment of severe infections.
Product Portfolio
Cumberland's portfolio includes a range of innovative therapies:
- Acetadote®: An intravenous treatment for acetaminophen overdose to prevent liver damage.
- Caldolor®: The first FDA-approved intravenous ibuprofen for pain and fever management, now approved for use in infants as young as 3 months.
- Kristalose®: A prescription-strength laxative for acute and chronic constipation.
- Omeclamox®-Pak: A combination therapy for Helicobacter pylori infection and duodenal ulcer disease.
- Sancuso®: The only FDA-approved transdermal patch for chemotherapy-induced nausea and vomiting.
- Vaprisol®: An intravenous treatment for hyponatremia in critical care settings.
- Vibativ®: A potent antibiotic for multidrug-resistant Gram-positive infections, including hospital-acquired and ventilator-associated pneumonia.
Clinical Development Pipeline
Cumberland is actively advancing its clinical development pipeline, with a focus on rare and orphan diseases. Key programs include:
- Ifetroban: A selective thromboxane receptor antagonist being evaluated in Phase II trials for systemic sclerosis, cardiomyopathy associated with Duchenne muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF). The drug has received both Orphan Drug and Rare Pediatric Disease Designations from the FDA for its DMD indication.
These programs underscore the company's commitment to addressing critical unmet medical needs and expanding its therapeutic footprint.
Market Position and Competitive Landscape
Cumberland operates in a competitive yet specialized niche within the pharmaceutical industry. By focusing on underserved markets and leveraging its expertise in hospital acute care and specialty therapies, the company differentiates itself from larger pharmaceutical players. Its strategy of acquiring and enhancing existing products allows it to mitigate some of the risks associated with new drug development while maintaining a robust pipeline for future growth.
Global Reach
While Cumberland's primary market is the United States, the company has established partnerships with international distributors to expand the availability of its products globally. Recent developments include regulatory approvals and product launches in markets such as China, Saudi Arabia, and Mexico.
Commitment to Quality and Patient Care
Cumberland is committed to improving patient outcomes through innovative therapies and rigorous quality standards. The company's efforts to enhance its product labeling, expand clinical indications, and support patient access initiatives reflect its dedication to addressing unmet medical needs and improving the quality of care.
Conclusion
With a diversified portfolio of FDA-approved products, a strong clinical pipeline, and a strategic focus on underserved markets, Cumberland Pharmaceuticals Inc. is well-positioned as a key player in the specialty pharmaceutical sector. Its commitment to innovation, quality, and patient care underscores its role in addressing critical healthcare challenges and delivering value to patients and healthcare providers alike.
Cumberland Pharmaceuticals (NASDAQ: CPIX) reported Q4 2024 net revenues of $10.4 million, up 11.6% year-over-year, with full-year 2024 revenues reaching $38 million. The company ended 2024 with $76 million in total assets, including $18 million cash.
Key 2024 product revenues included Kristalose ($15.3M), Sancuso ($9M), Vibativ ($7.2M), and Caldolor ($5M). The company reported a Q4 net loss of $1.9M and full-year net loss of $6.4M.
Significant developments include:
- Positive Phase II study results for ifetroban in Duchenne muscular dystrophy patients
- Vibativ approval in China
- FDA Orphan Drug and Rare Pediatric Disease designations for ifetroban
- New simplified dosing regimen approval for Acetadote
- Publication of Caldolor comparative study showing advantages over ketorolac
Cumberland Pharmaceuticals (Nasdaq: CPIX) announced it will release its annual 2024 financial results after market close on March 4, 2025, followed by a conference call at 4:30 p.m. Eastern Time.
The specialty pharmaceutical company maintains a portfolio of FDA-approved brands including:
- Acetadote® for acetaminophen poisoning
- Caldolor® for pain and fever
- Kristalose® for constipation
- Sancuso® for chemotherapy-related nausea
- Vaprisol® for hyponatremia
- Vibativ® for bacterial infections
Additionally, Cumberland has Phase II clinical programs ongoing for its ifetroban candidate, targeting Systemic Sclerosis, Duchenne Muscular Dystrophy-associated cardiomyopathy, and Idiopathic Pulmonary Fibrosis.
Cumberland Pharmaceuticals (CPIX) and SciClone Pharmaceuticals announced that Vibativ® (telavancin) injection has received NMPA marketing approval in China. Vibativ is an FDA-approved injectable antibiotic used to treat hospital-acquired pneumonia and complicated skin infections, including those caused by drug-resistant bacteria.
The approval enables SciClone to exclusively register, promote, and distribute Vibativ in China, the world's second-largest market. The companies plan to launch the product later this year. Two published studies involving over 39,000 clinical isolates demonstrate that Vibativ maintains its potency against difficult-to-treat and multidrug-resistant bacteria, even after a decade since its introduction.
Vibativ has shown significantly higher cure rates compared to vancomycin in certain pneumonia cases and doesn't require therapeutic drug monitoring. A recent study also suggested the drug's safety in children aged 2-17 years.
Cumberland Pharmaceuticals (CPIX) announced breakthrough results from its Phase 2 FIGHT DMD trial evaluating ifetroban for Duchenne muscular dystrophy (DMD) heart disease. The 12-month study enrolled 41 DMD patients, testing low dose (150mg) and high dose (300mg) ifetroban against placebo.
The trial showed significant positive outcomes: The high-dose group demonstrated a 3.3% overall improvement in left ventricular ejection fraction (LVEF), with a 1.8% increase compared to a 1.5% decline in the placebo group. When compared to natural history controls, the difference was even more pronounced, showing a 5.4% overall improvement versus a 3.6% decline in controls.
Ifetroban, a once-daily oral thromboxane receptor antagonist, was well-tolerated with no serious drug-related events. The drug has received both Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA. If approved, it would be the first therapy specifically indicated for DMD-related heart disease.
Cumberland Pharmaceuticals (Nasdaq: CPIX) announced FDA approval of a supplemental New Drug Application (sNDA) for Acetadote®, its intravenous N-acetylcysteine treatment for acetaminophen poisoning. The new approval introduces a simplified dosing regimen that combines the first two bags of the standard treatment into a single, slower infusion.
The streamlined approach has been proven to reduce medication errors and non-allergic anaphylactoid reactions while maintaining effectiveness. This modification aims to improve treatment efficiency for acetaminophen overdose, which is the leading cause of acute liver failure in the United States.
Cumberland Pharmaceuticals announced its Q3 2024 financial results and company updates. The company achieved $9.1 million in revenues for the quarter, with $27 million year-to-date. Key product revenues included $3.6 million from Kristalose and $2.6 million from Sancuso. Operating expenses were $10.8 million, leading to a net loss of $1.5 million or $0.11 per share. The balance sheet shows $76.7 million in total assets and $52.3 million in liabilities.
Notable updates include a real-world study favoring Caldolor, expanded Medicaid coverage for Kristalose, and international partnerships for Vibativ. The company’s DMD program received both FDA Orphan Drug and Rare Pediatric Disease designations. Cumberland's Emerging Technologies program is advancing new treatments, including a promising delirium treatment and a diagnostic for internal bleeding.
Cumberland Pharmaceuticals (NASDAQ: CPIX) announced that the FDA has granted both Orphan Drug Designation and Rare Pediatric Disease Designation to Ifetroban for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD). The company is completing the FIGHT DMD™ trial, a Phase II study investigating Ifetroban in DMD patients, with results expected later this year. DMD affects approximately 1 in 3,300 male births worldwide and is characterized by damage to skeletal and cardiac muscle, with cardiomyopathy being the primary cause of death. These FDA designations could provide various benefits including tax credits, user fee exemptions, and potential market exclusivity.
Cumberland Pharmaceuticals (Nasdaq: CPIX) announced new research comparing Caldolor (ibuprofen injection) to ketorolac in over 150,000 patients. The study, published in Frontiers of Pain Research, analyzed 31,046 Caldolor and 124,184 ketorolac adult patients, plus 5,579 pediatric patients in each arm. Results showed Caldolor associated with 45% reduction in renal dysfunction and 78% decrease in hematuria rates in adults compared to ketorolac. In pediatric patients, Caldolor showed 51-65% lower adverse drug reaction rates. The medication also demonstrated improved healthcare resource utilization with decreased emergency room visits, outpatient visits, and shorter hospital stays.
Cumberland Pharmaceuticals (Nasdaq: CPIX) will release its third quarter 2024 financial results after market close on November 7, 2024, followed by a conference call at 4:30 p.m. Eastern Time. The company is a specialty pharmaceutical firm with a portfolio of six FDA-approved brands targeting hospital acute care, gastroenterology, and oncology markets. Their products include Acetadote, Caldolor, Kristalose, Sancuso, Vaprisol, and Vibativ. Additionally, Cumberland has Phase II clinical programs evaluating ifetroban for various conditions including Systemic Sclerosis, Duchenne Muscular Dystrophy-associated cardiomyopathy, and Idiopathic Pulmonary Fibrosis.
Cumberland Pharmaceuticals (Nasdaq: CPIX) reported 16% sequential revenue growth in Q2 2024, with net revenue reaching $9.9 million. The company achieved adjusted earnings of $0.2 million, a $0.8 million improvement over Q1 2024. Key developments include:
1. Kristalose added to Wisconsin Medicaid formulary and recommended in AGA guidelines
2. New study supports Vibativ as an effective treatment for anthrax infections
3. Progress in ifetroban clinical trials for various indications
4. New manufacturing and supplies of Sancuso
5. Potential Medicare reimbursement for Caldolor under the NOPAIN Act
Cumberland's CEO expressed optimism about the company's future, projecting significant revenue growth and positive cash flow from operations in 2024.
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