---
schema_version: "secwatch.filing_event.v1"
accession: "0001641172-25-017043"
form_type: "8-K"
ticker: "CELC"
cik: "0001603454"
company_name: "Celcuity Inc."
filed_at: "2025-06-30T23:59:59+00:00"
generated_at: "2026-05-18T13:00:13.716263+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Celcuity reports 66% six-month rPFS in mCRPC Phase 1, 43% ORR in HER2+ mBC Phase 2

## Summary
- 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.

## SEC filing metadata
- accession: 0001641172-25-017043
- form_type: 8-K
- ticker: CELC
- cik: 0001603454
- company_name: Celcuity Inc.
- filed_at: 2025-06-30T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1603454/000164117225017043/0001641172-25-017043-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1603454/000164117225017043/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001641172-25-017043
- JSON: https://secwatch.observer/filing/0001641172-25-017043.json
- Plain text: https://secwatch.observer/filing/0001641172-25-017043.txt

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