Cumberland Pharmaceuticals Inc CPIX
Cumberland Pharmaceuticals Inc (Nasdaq: CPIX) is a rare genetic drug developer. Its lead program, ifetroban, is in Phase 2 for cardiomyopathy associated with Duchenne muscular dystrophy (also SSc, IPF, cancer metastasis).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| ifetroban (DMD cardiomyopathy) | Duchenne muscular dystrophy cardiomyopathy | small molecule | Phase 2 |
| ifetroban (systemic sclerosis) | Systemic sclerosis | small molecule | Phase 2 |
| ifetroban (idiopathic pulmonary fibrosis) | IPF | small molecule | Phase 2 |
| ifetroban (cancer metastasis prevention) | high-risk solid tumors | small molecule | Phase 2 |
| CET delirium candidate | hospitalized patient delirium | unclear | Pre-clinical |
Recent results and decisions
- Oct 26, 2026submitted Cumberland announces plans to submit an NDA to the FDA for ifetroban as a treatment for cardiomyopathy associated with DMD following a pre-NDA meeting, with FDA granting rolling review status.
The Company announced plans to submit a New Drug Application ('NDA') to the U.S. Food and Drug Administration (the 'FDA') for ifetroban as a treatment for the cardiomyopathy associated with DMD.
Filing - Oct 26, 2026met The 12-month Phase 2 FIGHT DMD trial demonstrated that high-dose ifetroban resulted in a statistically significant 5.4% absolute improvement in left ventricular ejection fraction compared to controls.
The 12-month Phase 2 FIGHT DMD™ trial (NCT03340675) demonstrated that high-dose ifetroban treatment resulted in a statistically significant 5.4% absolute improvement in left ventricular ejection fraction (LVEF) (p=0.002) compared to a control group composed of placebo-treated patients combined with
Filing - Oct 26, 2026accepted FDA granted Cumberland's request for rolling review of the ifetroban NDA, allowing completed sections to be submitted before the full application.
Following the meeting the FDA granted the Company's request for rolling review of the NDA, which allows completed sections of the application to be provided to the FDA for review, before the full application is submitted.
Filing
5 more on record.
For subscribers
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Other phase 2 rare genetic companies
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