Welcome to our dedicated page for Cumberland Pharmaceuticals news (Ticker: CPIX), a resource for investors and traders seeking the latest updates and insights on Cumberland Pharmaceuticals stock.
Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) provides specialty pharmaceutical solutions for critical care and underserved medical needs. This news hub offers investors and healthcare professionals verified updates on the company's FDA-approved therapies, clinical developments, and strategic initiatives.
Access timely reports on product approvals, clinical trial milestones, and corporate partnerships across Cumberland's core therapeutic areas: hospital acute care, oncology support, gastroenterology treatments, and rare disease therapies. Our curated news collection enables informed decision-making through coverage of financial results, regulatory submissions, and market expansion efforts.
Key updates include developments for Cumberland's Ifetroban clinical program targeting rare conditions, international distribution agreements, and innovations in pain management solutions like Caldolor®. All content undergoes strict verification to ensure accuracy and relevance for stakeholders.
Bookmark this page for centralized access to CPIX's latest pharmaceutical advancements and corporate announcements. Check regularly for essential updates impacting the specialty medicine sector.
Cumberland Pharmaceuticals (NASDAQ: CPIX) has partnered with Qureight to enhance data analysis in its Phase II FIGHTING FIBROSIS™ clinical trial for idiopathic pulmonary fibrosis (IPF). The trial is evaluating Cumberland's ifetroban product candidate in IPF patients over 52 weeks. Qureight's deep-learning AI platform will analyze CT imaging data to measure changes in patients' fibrotic, vascular, and airway lung compartments.
The multicenter, double-blind, placebo-controlled study aims to address an unmet need for the estimated 2 million IPF patients worldwide. The trial's primary endpoint focuses on changes in forced vital capacity and includes patients both on and off existing antifibrotic therapies. The study is currently actively enrolling at 16 centers out of planned 20+ medical centers across the U.S., targeting 128 patients total.
Cumberland Pharmaceuticals (NASDAQ: CPIX) reported strong Q1 2025 financial results with net revenues of $11.7 million, marking a 38% increase from the previous year. The company achieved a net profit of $1.3 million, adjusted earnings of $2.4 million, and operating cash flow of $3.9 million.
Key developments include positive Phase II study results for ifetroban in Duchenne muscular dystrophy (DMD) patients, marking the first successful Phase II study targeting cardiac complications in DMD. Additionally, Cumberland's antibiotic Vibativ® received regulatory approval in China, opening access to the world's second-largest pharmaceutical market.
The company's Q1 2025 product revenue breakdown includes Kristalose® ($3.5M), Sancuso® ($2.3M), Vibativ® ($1.4M), and Caldolor® ($1.3M). Cumberland ended the quarter with $70 million in total assets and $28.7 million in shareholders' equity.
Cumberland Pharmaceuticals (Nasdaq: CPIX) has scheduled its Q1 2025 financial results announcement and company update for Tuesday, May 6, 2025, after market close. A conference call will follow at 4:30 p.m. Eastern Time.
The specialty pharmaceutical company focuses on unique products across three key segments: hospital acute care, gastroenterology, and oncology. Their FDA-approved portfolio includes:
- Acetadote® for acetaminophen poisoning
- Caldolor® for pain and fever
- Kristalose® for constipation
- Sancuso® for chemotherapy-related nausea
- Vaprisol® for hyponatremia
- Vibativ® for bacterial infections
The company is also conducting Phase II clinical trials of ifetroban for multiple conditions, including Systemic Sclerosis, Duchenne Muscular Dystrophy cardiomyopathy, and Idiopathic Pulmonary Fibrosis.
Cumberland Pharmaceuticals (NASDAQ: CPIX) announced breakthrough results from its Phase 2 FIGHT DMD clinical trial, presented at the Muscular Dystrophy Association Conference. The study evaluated ifetroban for Duchenne muscular dystrophy (DMD) heart disease.
Key findings showed that high-dose ifetroban treatment achieved a 3.3% improvement in left ventricular ejection fraction (LVEF) compared to placebo. When compared to natural history controls, the improvement was even more significant at 5.4%, while control patients showed a 3.6% LVEF decline.
Ifetroban, an oral thromboxane receptor antagonist, has received both Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA for DMD-related heart disease. The company is preparing for an end-of-Phase-2 meeting with the FDA to discuss development and commercialization next steps.
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.
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