secwatch.observer — SEC 8-K summary
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Issuer:     Celcuity Inc. (CELC)
CIK:        0001603454
Form:       8-K
Filed at:   2023-08-22T23:59:59+00:00
Accession:  0001493152-23-029858
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1603454/000149315223029858/0001493152-23-029858-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1603454/000149315223029858/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-23-029858

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