Earnings summaries and quarterly performance for CUMBERLAND PHARMACEUTICALS.
Executive leadership at CUMBERLAND PHARMACEUTICALS.
Board of directors at CUMBERLAND PHARMACEUTICALS.
Research analysts covering CUMBERLAND PHARMACEUTICALS.
Recent press releases and 8-K filings for CPIX.
Cumberland Pharmaceuticals Receives FDA Fast Track Designation for Ifetroban DMD Program
CPIX
New Projects/Investments
- On February 4, 2026, Cumberland Pharmaceuticals Inc. (CPIX) announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for its novel oral therapy, ifetroban, for Duchenne muscular dystrophy (DMD) heart disease.
- This designation is intended to expedite the development and review process for ifetroban, allowing for more frequent communication with the FDA and rolling submission of marketing applications.
- The designation follows positive results from its Phase 2 FIGHT DMD trial, which demonstrated a 5.4% improvement in left ventricular ejection fraction (LVEF) over 12 months of treatment.
- Ifetroban had previously received both Orphan Drug Designation and Rare Pediatric Disease Designation, underscoring the urgent and critical unmet medical need for DMD heart disease, for which no specific therapies are currently approved.
2 days ago
Cumberland Pharmaceuticals Receives FDA Fast Track Designation for Ifetroban in DMD Heart Disease
CPIX
New Projects/Investments
- Cumberland Pharmaceuticals Inc. (CPIX) has received Fast Track Designation from the FDA for ifetroban, its novel oral therapy targeting a fatal form of heart disease in Duchenne muscular dystrophy (DMD) patients.
- This designation is intended to expedite the development and review process for ifetroban, which had previously received Orphan Drug and Rare Pediatric Disease Designations.
- The Fast Track Designation follows positive results from the Phase 2 FIGHT DMD trial, which demonstrated a 5.4% improvement in left ventricular ejection fraction (LVEF) over 12 months of treatment.
- There are currently no approved therapies specifically targeting DMD-related heart disease, highlighting a critical unmet medical need.
3 days ago
Cumberland Pharmaceuticals' Caldolor J-Code Now Linked to Reimbursement Price
CPIX
Product Launch
New Projects/Investments
- Cumberland Pharmaceuticals Inc. (CPIX) announced that the permanent J-code, J1741, for its Caldolor® (ibuprofen) Injection is now officially associated with a reimbursement price.
- This development provides healthcare providers with a CMS-covered, non-opioid option for managing pain and fever.
- The update supports providers in making clinically appropriate decisions and contributes to efforts to reduce opioid exposure.
Dec 8, 2025, 2:05 PM
Cumberland Pharmaceuticals Reports Q3 2025 Financial Results and Product Developments
CPIX
Earnings
Product Launch
New Projects/Investments
- Cumberland Pharmaceuticals reported net revenues of $8.3 million for the third quarter of 2025, with year-to-date revenues totaling $30.8 million, representing a 12% increase over the first nine months of 2024.
- The company recorded a net loss of $1.9 million for Q3 2025 and a year-to-date net loss of $1.4 million. Adjusted earnings for the first nine months of 2025 were $1.9 million, or $0.13 per diluted share.
- As of September 30, 2025, Cumberland's balance sheet showed approximately $66 million in total assets, $40 million in liabilities, and $26 million in shareholders' equity.
- Cumberland expanded its commercial portfolio by entering arrangements to jointly commercialize Talicia® for H. pylori infection, and announced the launch of Vibativ® in Saudi Arabia and regulatory approval for its ibuprofen injection product in Mexico.
- The company presented breakthrough findings from its Phase II FIGHT DMD trial for ifetroban, demonstrating a 5.4% improvement in cardiac function in Duchenne muscular dystrophy patients, and is advancing other ifetroban clinical studies.
Nov 4, 2025, 10:11 PM
Cumberland Pharmaceuticals Reports Q3 2025 Results and Product Portfolio Expansion
CPIX
Earnings
Product Launch
New Projects/Investments
- Cumberland Pharmaceuticals reported $8.3 million in combined net revenues for the third quarter of 2025 and $30.8 million for the first nine months of 2025, marking a 12% increase in year-to-date revenues compared to the same period in 2024.
- The company ended the third quarter of 2025 with $66 million in total assets, $40 million in liabilities, and $26 million in shareholders' equity.
- Cumberland expanded its commercial portfolio by adding Talicia® through a joint commercialization agreement with RedHill Biopharma Ltd., involving a $4 million investment for a 30% ownership in the new entity, Talicia Holdings, Inc..
- Internationally, Cumberland launched Vibativ® in Saudi Arabia, received regulatory approval for its ibuprofen injection product in Mexico, and previously secured approval for Vibativ® in China.
- For the third quarter of 2025, Cumberland reported a net loss of approximately $1.9 million and an adjusted loss of $0.8 million, or $0.06 per share.
Nov 4, 2025, 10:00 PM
Cumberland Pharmaceuticals Reports Q3 2025 Financial Results and Strategic Updates
CPIX
Earnings
Product Launch
New Projects/Investments
- Cumberland Pharmaceuticals reported Q3 2025 revenues of $8.3 million and year-to-date revenues of $30.9 million, representing 12% growth over the prior year period. The company posted an adjusted loss of $0.8 million ($0.06 per share) for Q3 2025, with year-to-date adjusted earnings of $1.9 million ($0.13 per share).
- The company entered a joint commercialization agreement with RedHill Biopharma for Talicia, an FDA-approved treatment for H. pylori infections, forming Talicia Holdings, Inc.. Cumberland will invest $2 million this year and $2 million next year, and will equally share Talicia's net revenues.
- International expansion continued with the launch of Vibativ in Saudi Arabia and regulatory approval for its ibuprofen injection product in Mexico. Preparations are also underway for the launch of Vibativ in China following its approval earlier this year.
- Positive top-line results from the FITE-DMD trial for the Ifetroban product candidate showed a 3.3% overall improvement in left ventricular ejection fraction for high-dose Ifetroban in Duchenne muscular dystrophy patients. An end-of-phase 2 meeting with the FDA was held in September.
Nov 4, 2025, 9:30 PM
Cumberland Pharmaceuticals Announces Joint Commercialization Agreement for Talicia
CPIX
M&A
New Projects/Investments
Revenue Acceleration/Inflection
- Cumberland Pharmaceuticals (CPIX) and RedHill Biopharma Ltd. (RDHL) have entered into a strategic co-commercialization agreement for Talicia®, an FDA-approved oral capsule for Helicobacter pylori infection.
- Under the agreement, a new, jointly owned company will be formed, with Cumberland providing $4 million in investment capital and RedHill contributing all Talicia assets.
- Cumberland will manage product distribution and record sales, with the companies equally sharing net revenues; Talicia generated $8 million in net revenues in 2024.
- Talicia is patent protected through 2042 and has eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation.
Oct 20, 2025, 1:05 PM
Cumberland Pharmaceuticals' Injectable Ibuprofen Approved in Mexico
CPIX
Product Launch
New Projects/Investments
- Cumberland Pharmaceuticals (CPIX) announced that its ibuprofen injection product received regulatory approval in Mexico on October 1, 2025.
- This approval is a result of a partnership with PiSA Farmaceutica, which has exclusive supply and distribution rights for the product in the Mexican market.
- The injectable ibuprofen is designed for intravenous delivery to manage pain and reduce fever in hospital and surgical settings, and has been shown to reduce post-operative pain and decrease the need for opioid medications.
Oct 1, 2025, 1:05 PM
Quarterly earnings call transcripts for CUMBERLAND PHARMACEUTICALS.
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