secwatch.observer — SEC 8-K summary
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Issuer:     SOLIGENIX, INC. (SNGX)
CIK:        0000812796
Form:       8-K
Filed at:   2024-04-03T23:59:59+00:00
Accession:  0001558370-24-004663
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Soligenix gets EMA agreement on confirmatory Phase 3 design for HyBryte in CTCL
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- EMA agreed on key design for FLASH2: double-blind, placebo-controlled, 18-week continuous treatment.
- Study to enroll ~80 early-stage CTCL patients in US and Europe; enrollment targeted by end of 2024.
- Primary endpoint: ≥50% reduction in mCAILS score at Week 18; top-line results expected H2 2026.
- FLASH2 replicates first Phase 3 design but extends continuous treatment without breaks.
- Discussions with FDA on US development path remain ongoing; company prioritizes EMA pathway.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/812796/000155837024004663/0001558370-24-004663-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/812796/000155837024004663/sngx-20240403x8k.htm
  HTML page:      https://secwatch.observer/filing/0001558370-24-004663

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer