---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-24-046827"
form_type: "8-K"
ticker: "CPIX"
cik: "0001087294"
company_name: "CUMBERLAND PHARMACEUTICALS INC"
filed_at: "2024-11-12T23:59:59+00:00"
generated_at: "2026-05-30T01:32:56.874477+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# Cumberland Pharma receives FDA Orphan Drug and Rare Pediatric Disease designations for Ifetroban in DMD

## Summary
- FDA granted Orphan Drug and Rare Pediatric Disease Designations to Ifetroban for cardiomyopathy associated with Duchenne muscular dystrophy.
- Cumberland is completing the FIGHT DMD Phase II trial; results expected later in 2024.
- Rare Pediatric Disease Designation may qualify company for a priority review voucher upon approval.
- Orphan Drug Designation provides seven-year market exclusivity, tax credits, and fee waivers if approved.

## SEC filing metadata
- accession: 0001628280-24-046827
- form_type: 8-K
- ticker: CPIX
- cik: 0001087294
- company_name: CUMBERLAND PHARMACEUTICALS INC
- filed_at: 2024-11-12T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1087294/000162828024046827/0001628280-24-046827-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1087294/000162828024046827/cpix-20241106.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-24-046827
- JSON: https://secwatch.observer/filing/0001628280-24-046827.json
- Plain text: https://secwatch.observer/filing/0001628280-24-046827.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.