secwatch.observer — SEC 8-K summary
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Issuer:     Celcuity Inc. (CELC)
CIK:        0001603454
Form:       8-K
Filed at:   2025-06-30T23:59:59+00:00
Accession:  0001641172-25-017043
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Celcuity reports 66% six-month rPFS in mCRPC Phase 1, 43% ORR in HER2+ mBC Phase 2
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- Phase 1 mCRPC (gedatolisib + darolutamide): 66% six-month rPFS; no treatment-related discontinuations or Grade 3 hyperglycemia; Grade 2-3 stomatitis in 10.5% of patients.
- Phase 2 HER2+ mBC (gedatolisib + trastuzumab-pkrb): ORR 43%, median PFS 6.0 months, median OS 24.7 months; no discontinuations due to treatment-related AEs; 2.3% Grade 3 hyperglycemia.
- Protocol amended to explore additional gedatolisib doses in mCRPC Phase 1/1b; up to six patients per arm in three arms, then Phase 1b with up to 40 patients to determine RP2D.
- No prophylaxis for stomatitis used in the mBC trial; data cut-off Feb 10, 2025; results presented at ASCO June 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1603454/000164117225017043/0001641172-25-017043-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1603454/000164117225017043/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001641172-25-017043

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