Cumberland Pharmaceuticals Inc Stock Price, News & Analysis

Cumberland Pharmaceuticals (NASDAQ: CPIX) has secured a significant contract with Vizient, the nation's largest healthcare performance improvement company, for its new Vibativ® 4-Vial Starter Pak. Vizient serves over 65% of U.S. acute care providers, including 97% of academic medical centers.

Vibativ® is an FDA-approved injectable antibiotic for treating hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) and complicated skin infections caused by Gram-positive pathogens, including MRSA. The drug has demonstrated significantly higher cure rates compared to vancomycin in HABP/VABP cases with specific pathogen profiles.

This contract enhances accessibility to Vibativ's new 4-vial configuration, supporting flexible treatment initiation across inpatient and outpatient settings.

Cumberland Pharmaceuticals (NASDAQ: CPIX) announced it will release its Q2 2025 financial results and company update after market close on Tuesday, August 5, 2025, followed by a conference call at 4:30 p.m. Eastern Time.

The company, focused on specialty pharmaceuticals, maintains a portfolio of six FDA-approved products targeting hospital acute care, gastroenterology, and oncology segments. Additionally, Cumberland has ongoing Phase II clinical programs evaluating ifetroban for three conditions: Systemic Sclerosis, Duchenne Muscular Dystrophy-associated cardiomyopathy, and Idiopathic Pulmonary Fibrosis.

Cumberland Pharmaceuticals (NASDAQ: CPIX) presented positive Phase 2 FIGHT DMD trial results for ifetroban, their novel oral therapy for Duchenne muscular dystrophy (DMD) heart disease, at the PPMD conference. The trial showed a significant 5.4% improvement in left ventricular ejection fraction with high-dose ifetroban compared to control groups. The drug demonstrated reduced cardiac damage markers while being well-tolerated, with all patients opting to continue treatment in the open-label extension. Ifetroban, which has received both Orphan Drug and Rare Pediatric Disease Designations from the FDA, works by blocking the thromboxane receptor involved in inflammation and fibrosis. The results are particularly significant as DMD-related heart disease, currently without approved treatments, is the leading cause of death in DMD patients.

Cumberland Pharmaceuticals (NASDAQ: CPIX) announced positive results from a study of Caldolor® (intravenous ibuprofen) in patients aged 60 and older. The analysis, involving data from four clinical studies with 1,041 patients, demonstrated significant benefits in pain management. Key findings showed Caldolor reduced pain by 24% at rest and 20% with movement between 6-24 hours post-surgery compared to placebo. Notably, the treatment led to a 23.2% reduction in post-operative morphine requirements. The safety profile was favorable, with Caldolor-treated patients experiencing fewer adverse events (55%) compared to placebo (90%). The study is particularly significant as it addresses pain management needs in older adults, who comprise nearly one-third of ambulatory surgeries and are often underrepresented in clinical trials.

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