---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-23-001226"
form_type: "8-K"
ticker: "SNGX"
cik: "0000812796"
company_name: "SOLIGENIX, INC."
filed_at: "2023-02-14T23:59:59+00:00"
generated_at: "2026-06-19T14:56:44.301033+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Soligenix receives FDA Refusal to File for HyBryte NDA in CTCL

## Summary
- FDA issued Refusal to File (RTF) letter for HyBryte NDA for early-stage cutaneous T-cell lymphoma.
- NDA submitted Dec 14, 2022 deemed not sufficiently complete for substantive review.
- Soligenix plans to request a Type A meeting to clarify issues and seek guidance for resubmission.
- Cutaneous T-cell lymphoma is a rare cancer affecting over 25,000 patients in the U.S.

## SEC filing metadata
- accession: 0001558370-23-001226
- form_type: 8-K
- ticker: SNGX
- cik: 0000812796
- company_name: SOLIGENIX, INC.
- filed_at: 2023-02-14T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/812796/000155837023001226/0001558370-23-001226-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/812796/000155837023001226/tmb-20230214x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-23-001226
- JSON: https://secwatch.observer/filing/0001558370-23-001226.json
- Plain text: https://secwatch.observer/filing/0001558370-23-001226.txt

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