Cumberland Pharmaceuticals Inc Stock Price, News & Analysis

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.

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.