---
schema_version: "secwatch.filing_event.v1"
accession: "0001023024-25-000072"
form_type: "8-K"
ticker: "ANIP"
cik: "0001023024"
company_name: "ANI PHARMACEUTICALS INC"
filed_at: "2025-07-23T23:59:59+00:00"
generated_at: "2026-05-18T03:04:27.633966+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# ANI Pharma posts preliminary Q2 ILUVIEN/YUTIQ revenue of $22.3M; NEW DAY trial misses primary endpoint

## Summary
- Preliminary combined ILUVIEN/YUTIQ net revenues for Q2 2025: $22.3M.
- NEW DAY trial primary endpoint: mean supplemental injections 2.4 (ILUVIEN) vs. 2.5 (aflibercept); p=0.756, not significant.
- Secondary endpoint met: mean time to first supplemental injection 185.4 vs. 132.8 days (p<0.001).
- Post-hoc per-protocol analysis: ILUVIEN arm 1.8 vs. 2.5 supplemental injections (p=0.029); total 2.8 vs. 7.5 injections.
- Safety: 41% treatment-related TEAE in ILUVIEN arm (cataract, IOP increase) vs. 3% in aflibercept arm.

## SEC filing metadata
- accession: 0001023024-25-000072
- form_type: 8-K
- ticker: ANIP
- cik: 0001023024
- company_name: ANI PHARMACEUTICALS INC
- filed_at: 2025-07-23T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1023024/000102302425000072/0001023024-25-000072-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1023024/000102302425000072/ani-20250723.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001023024-25-000072
- JSON: https://secwatch.observer/filing/0001023024-25-000072.json
- Plain text: https://secwatch.observer/filing/0001023024-25-000072.txt

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