secwatch.observer — SEC 8-K summary
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Issuer:     Celldex Therapeutics, Inc. (CLDX)
CIK:        0000744218
Form:       8-K
Filed at:   2023-03-22T23:59:59+00:00
Accession:  0001104659-23-035198
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Celldex refutes false report; barzolvolimab PN study continues, Phase 2 subQ planned
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- Inaccurate report at AAD Annual Meeting stated Celldex terminated Phase 1b barzolvolimab study in prurigo nodularis due to SAE.
- Celldex clarifies study not terminated; DRC unanimously recommended program proceed despite anaphylactic SAE in complicated patient.
- Enrollment closed at 24 patients due to IV administration challenges; blinded study continues with data expected Q4 2023.
- Celldex plans Phase 2 subcutaneous study in PN in late 2023 or early 2024.
- No safety events reported that would meaningfully impact the barzolvolimab development program.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/744218/000110465923035198/0001104659-23-035198-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/744218/000110465923035198/tm2310208d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-23-035198

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