Core Insights - Cumberland Pharmaceuticals Inc. presented positive results from the Phase 2 FIGHT DMD trial for ifetroban, a novel oral therapy targeting Duchenne muscular dystrophy (DMD) heart disease, at the PPMD conference, indicating its potential to protect the heart and reduce cardiac damage in DMD patients [1][2][8] Group 1: Trial Results - The 12-month Phase 2 FIGHT DMD trial demonstrated a significant 5.4% improvement in left ventricular ejection fraction (LVEF) in patients treated with high-dose ifetroban compared to a control group [4] - High-dose ifetroban treatment was associated with reduced blood levels of cardiac damage markers (NT-proBNP and cardiac troponin I), while these markers increased in placebo-treated patients, suggesting ifetroban's potential to prevent ongoing cardiac injury [5] - All patients who completed the study opted to continue with the open-label extension, indicating confidence in the treatment [7] Group 2: Pharmacokinetics and Tolerability - The study revealed that DMD patients receiving higher doses of ifetroban achieved similar plasma levels to typical adults without evidence of drug accumulation, supporting the 300 mg daily dosing used in the high-dose group [6] - Ifetroban was well-tolerated with an acceptable pharmacokinetic profile in patients with DMD, despite the higher dosing requirements [6] Group 3: Market Potential and Regulatory Pathway - Ifetroban is positioned to address the leading cause of death in DMD patients, with no approved treatment specifically targeting DMD heart disease, highlighting a critical unmet medical need [9][10] - The company plans to analyze long-term treatment results and engage in discussions with the FDA regarding the regulatory pathway forward based on the trial's encouraging results [10]

Cumberland Pharmaceuticals Inc (CPIX) Q1 2025 Earnings Call May 06, 2025 04:30 PM ET Company Participants Molly Aggas - Account SupervisorA.J. Kazimi - Founder, Chairman & CEOTodd Anthony - Vice President of Organizational DevelopmentJohn Hamm - VP & CFO Operator Good afternoon, and welcome to the Cumberland Pharmaceuticals first quarter twenty twenty five financial report and company update. This call is being recorded at the company's request and will be archived on its website for one year from today's d ...

Cumberland Pharmaceuticals Inc (CPIX) Q1 2025 Earnings Call May 06, 2025 04:30 PM ET Speaker0 Good afternoon, and welcome to the Cumberland Pharmaceuticals first quarter twenty twenty five financial report and company update. This call is being recorded at the company's request and will be archived on its website for one year from today's date. I would now like to turn the call over to Molly Agus, account supervisor at the Dalton agency who handles Cumberland's communications. Molly, please proceed. Speaker ...

Company Update - Cumberland Pharmaceuticals Inc. will release its first quarter 2025 financial results and provide a company update on May 6, 2025, after market close [1] - A conference call is scheduled for May 6 at 4:30 p.m. Eastern Time to discuss the results and updates [1] Company Overview - Cumberland Pharmaceuticals is a specialty pharmaceutical company focused on developing, acquiring, and commercializing products for hospital acute care, gastroenterology, and oncology market segments [3] - The company has a portfolio of FDA-approved brands, including Acetadote®, Caldolor®, Kristalose®, Sancuso®, Vaprisol®, and Vibativ® [5] Clinical Programs - The company is conducting Phase II clinical programs evaluating its ifetroban product candidate for conditions such as Systemic Sclerosis, cardiomyopathy associated with Duchenne Muscular Dystrophy, and Idiopathic Pulmonary Fibrosis [3]

Core Insights - Cumberland Pharmaceuticals announced significant results from its Phase 2 FIGHT DMD clinical trial, demonstrating a 5.4% improvement in cardiac function for patients with Duchenne muscular dystrophy (DMD) [1][3][4] Group 1: Clinical Trial Results - The Phase 2 FIGHT DMD trial showed that high-dose ifetroban treatment resulted in a 3.3% improvement in left ventricular ejection fraction (LVEF) compared to placebo [3] - When compared to propensity-matched natural history controls, high-dose treatment provided a significant 5.4% overall improvement in LVEF, while control patients experienced a 3.6% decline [3] - These improvements in cardiac function could lead to enhanced quality of life and survival for DMD patients [3] Group 2: Drug Information - Ifetroban is an oral thromboxane receptor antagonist that has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA for DMD-related heart disease [4][7][8] - If approved, ifetroban would be the first therapy specifically indicated for DMD-related heart disease [8] Group 3: Company and Industry Context - Cumberland Pharmaceuticals is focused on developing treatments for rare diseases, with a growing portfolio of patents related to ifetroban for DMD [5][11] - The company is preparing for an end-of-Phase-2 meeting with the FDA to discuss the next steps for ifetroban's development and commercialization [5] - Current therapies for DMD primarily focus on preserving muscle function, highlighting the urgent need for treatments addressing cardiac complications [4][6]

Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX) Q4 2024 Earnings Conference Call March 4, 2025 4:30 PM ET Company Participants Molly Aggas – Account Supervisor-Dalton Agency A.J. Kazimi – Chief Executive Officer Todd Anthony – Vice President-Organizational Development John Hamm – Chief Financial Officer Conference Call Participants Operator Good afternoon, and welcome to Cumberland Pharmaceuticals Fourth Quarter 2024 Financial Report and Company Update. This call is being recorded at company’s request and wil ...