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Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) is a specialty pharmaceutical company dedicated to the acquisition, development, and commercialization of branded prescription pharmaceutical products. With a focus on high-quality products, Cumberland targets underserved physician segments in hospital acute care, gastroenterology, rheumatology, and oncology.
The company’s diverse portfolio includes FDA-approved brands like Acetadote, Caldolor, Kristalose, Omeclamox, Sancuso, Vaprisol, and Vibativ. These products are promoted through hospital, field, and oncology sales divisions in the United States, and a network of international partners ensures they reach patients globally. Cumberland's revenue largely comes from the sales of these pharmaceutical brands.
Recent achievements include the publication of a clinical study in Antimicrobial Agents and Chemotherapy highlighting the safety and pharmacokinetics of Vibativ in pediatric patients aged 2 to 17. Another significant milestone is the FDA's expanded labeling approval for Caldolor to include use in infants, making it the first non-opioid injection approved for treating pain and fever in infants aged 3 to 6 months.
Financially, Cumberland reported combined revenues of $10.1 million for the third quarter of 2023, bringing the year-to-date total to $30.2 million. Despite a third quarter net loss of $1.0 million, the company posted a year-to-date net income of $15,086, with adjusted earnings of $0.29 per share. The company ended the third quarter with $88 million in total assets, $52 million in liabilities, and $36 million in shareholders' equity.
In addition to product development, Cumberland continues to advance its pipeline with Phase II clinical programs evaluating ifetroban for conditions such as Duchenne Muscular Dystrophy-associated cardiomyopathy, Systemic Sclerosis, and Idiopathic Pulmonary Fibrosis. The promising results from these studies underscore the company's commitment to addressing unmet medical needs.
Cumberland Pharmaceuticals remains a pivotal player in the biopharmaceutical industry, with a mission to improve patient care through innovative products and dedicated clinical research.
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.
Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company, will release its second quarter 2024 financial results after market close on Tuesday, Aug. 6, 2024. A conference call will follow at 4:30 p.m. Eastern Time. The company focuses on providing unique products for hospital acute care, gastroenterology, and oncology markets. Cumberland's portfolio includes FDA-approved brands such as Acetadote®, Caldolor®, Kristalose®, Omeclamox®-Pak, Sancuso®, Vaprisol®, and Vibativ®. Additionally, Cumberland has Phase II clinical programs evaluating ifetroban for cardiomyopathy associated with Duchenne Muscular Dystrophy and Systemic Sclerosis, and recently received FDA clearance for a Phase II study in Idiopathic Pulmonary Fibrosis patients.
Cumberland Pharmaceuticals Inc. reported $8.5 million in combined revenues for the first quarter of 2024. The company has $82 million in total assets, $54 million in total liabilities, and $27 million in shareholders' equity. Recent developments include a special report on Caldolor, eligibility for Medicare reimbursement under the NOPAIN Act, new manufacturing of Sancuso, and clinical studies on ifetroban. Financially, net revenue was $8.5 million, with a net loss of $1.9 million and adjusted earnings of a $0.6 million loss. Cumberland continues to focus on innovative products for hospital acute care, gastroenterology, and oncology segments.
Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) will release its first quarter 2024 financial results on May 7, 2024. The company focuses on specialty pharmaceuticals for hospital acute care, gastroenterology, and oncology. They have FDA-approved products for various conditions and are conducting Phase II clinical trials for new treatments.
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