---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-23-005925"
form_type: "8-K"
ticker: "SNGX"
cik: "0000812796"
company_name: "SOLIGENIX, INC."
filed_at: "2023-04-14T23:59:59+00:00"
generated_at: "2026-06-17T02:18:37.304680+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Soligenix says FDA requires second Phase 3 study for HyBryte NDA after Type A meeting

## Summary
- FDA refused to file NDA for HyBryte (CTCL); requires positive results from a second clinical study.
- Type A Meeting held April 14, 2023; FDA open to protocol discussions for the additional study.
- Company disappointed but will collaborate with FDA; evaluating feasibility of conducting the trial.
- Phase 3 FLASH study was the largest double-blind, placebo-controlled CTCL trial; met primary endpoint.

## SEC filing metadata
- accession: 0001558370-23-005925
- form_type: 8-K
- ticker: SNGX
- cik: 0000812796
- company_name: SOLIGENIX, INC.
- filed_at: 2023-04-14T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/812796/000155837023005925/0001558370-23-005925-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/812796/000155837023005925/sngx-20230414x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-23-005925
- JSON: https://secwatch.observer/filing/0001558370-23-005925.json
- Plain text: https://secwatch.observer/filing/0001558370-23-005925.txt

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