---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-23-029858"
form_type: "8-K"
ticker: "CELC"
cik: "0001603454"
company_name: "Celcuity Inc."
filed_at: "2023-08-22T23:59:59+00:00"
generated_at: "2026-06-11T05:37:13.275507+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Celcuity to start Phase 1b/2 trial of gedatolisib + darolutamide in mCRPC; Bayer supplies drug free

## Summary
- FDA cleared IND for gedatolisib in combination with darolutamide; trial to begin Q1 2024.
- Phase 1b/2 study CELC-G-201 will enroll up to 54 mCRPC patients who progressed after first-line AR inhibitor.
- Bayer will provide Nubeqa (darolutamide) at no cost under clinical trial collaboration and supply agreement.
- Virtual Science Day scheduled for September 21, 2023 (10:00 a.m. – 12:00 p.m. ET) with key opinion leaders.

## SEC filing metadata
- accession: 0001493152-23-029858
- form_type: 8-K
- ticker: CELC
- cik: 0001603454
- company_name: Celcuity Inc.
- filed_at: 2023-08-22T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1603454/000149315223029858/0001493152-23-029858-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1603454/000149315223029858/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-23-029858
- JSON: https://secwatch.observer/filing/0001493152-23-029858.json
- Plain text: https://secwatch.observer/filing/0001493152-23-029858.txt

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