secwatch.observer — SEC 8-K summary
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Issuer:     SOLIGENIX, INC. (SNGX)
CIK:        0000812796
Form:       8-K
Filed at:   2023-04-14T23:59:59+00:00
Accession:  0001558370-23-005925
Event type: regulatory
Sentiment:  negative
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/812796/000155837023005925/0001558370-23-005925-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/812796/000155837023005925/sngx-20230414x8k.htm
  HTML page:      https://secwatch.observer/filing/0001558370-23-005925

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