---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-22-018677"
form_type: "8-K"
ticker: "SNGX"
cik: "0000812796"
company_name: "SOLIGENIX, INC."
filed_at: "2022-12-15T23:59:59+00:00"
generated_at: "2026-06-21T04:27:20.090344+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Soligenix submits NDA to FDA for HyBryte in cutaneous T-cell lymphoma; targets H2 2023 approval

## Summary
- NDA submitted for HyBryte (synthetic hypericin) to treat early stage CTCL, a rare cancer affecting >25,000 US patients.
- NDA has FDA orphan drug and fast track designations; company anticipates potential approval in H2 2023.
- Company estimates worldwide market for HyBryte in CTCL at over $250 million.
- US launch targeted for Q1 2024, contingent upon FDA approval.

## SEC filing metadata
- accession: 0001558370-22-018677
- form_type: 8-K
- ticker: SNGX
- cik: 0000812796
- company_name: SOLIGENIX, INC.
- filed_at: 2022-12-15T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/812796/000155837022018677/0001558370-22-018677-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/812796/000155837022018677/tmb-20221215x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-22-018677
- JSON: https://secwatch.observer/filing/0001558370-22-018677.json
- Plain text: https://secwatch.observer/filing/0001558370-22-018677.txt

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