Item 7.01 Regulation FD Disclosure . On June 26, 2026, Cumberland Pharmaceuticals Inc. (the “Company” or “Cumberland”) presented data from its Phase 2 FIGHT DMD trial evaluating ifetroban, a novel oral therapy for Duchenne muscular dystrophy (DMD) heart disease, at the annual Parent Project Muscular Dystrophy conference in Orlando, Florida.…
Filed Aug 28, 2026Accepted Aug 28, 2026, 5:08 PM EDTCIK 1087294Accession 0001087294-26-000064
Cumberland Pharmaceuticals Inc. is a Nashville-based biopharmaceutical company focused on developing new therapies for rare diseases. The company is advancing a late-stage pipeline of product candidates through a series of late stage clinical studies. The treatments are being developed across multiple therapeutic areas to address serious patient conditions that represent unmet medical needs. Cumberland's Phase 2 clinical programs are evaluating ifetroban in patients with Duchenne Muscular Dystrophy, Systemic Sclerosis, Idiopathic Pulmonary Fibrosis and Cancer Metastasis.
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Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01
Regulation FD Disclosure
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On June 26, 2026, Cumberland Pharmaceuticals Inc. (the “Company” or “Cumberland”) presented data from its Phase 2 FIGHT DMD trial evaluating ifetroban, a novel oral therapy for Duchenne muscular dystrophy (DMD) heart disease, at the annual Parent Project Muscular Dystrophy conference in Orlando, Florida. The presentation included a slide indicating that long-term safety and efficacy data from the ongoing open-label extension was expected in August 2026. The Company is providing this update to note that such data is not yet available and, accordingly, the Company no longer expects to present this data in August 2026. The Company intends to present this information at a future date when it becomes available.
Forward-Looking Statements
This Form 8-K contains forward-looking statements, which are subject to certain risks and reflect Cumberland’s current views on future events based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. Forward-looking statements include, among other things, statements regarding the Company’s intent, belief or expectations, and can be identified by the use of terminology such as “may,” “will,” “expect,” “believe,” “intend,” “plan,” “estimate,” “goal,” “should,” “seek,” “anticipate,” “look forward” and other comparable terms or the negative thereof. As with any business, all phases of Cumberland’s operations are subject to factors outside of its control, and any one or combination of these factors could materially affect Cumberland’s operation results. These factors include risks and uncertainties related to the strategic transaction, risks related to the Company’s ability to develop its pipeline of new product candidates, the risks inherent in clinical development and regulatory review, macroeconomic conditions, including changes in interest rates, inflation, tariffs, competition and other events beyond the Company’s control as more fully discussed in its most recent quarterly report on Form 10-Q as filed with the U.S. Securities and Exchange Commission (“SEC”), as well as the Company’s other filings with the SEC from time to time. There can be no assurance that results anticipated by the Company will be realized or that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The Company does not undertake any obligation to publicly revise these statements to reflect events after the date hereof.