8-K filed June 2, 2026, 8:10 AM ET ticker CELC CIK 0001603454

other material confidence high sentiment positive materiality 0.85

Gedatolisib doubles PFS vs alpelisib in PIK3CA mutant HR+/HER2- ABC Phase 3 trial

Celcuity Inc.

Gedatolisib-triplet reduced risk of progression or death by 50% (HR=0.50; p<0.0001); median PFS 11.1 vs 5.6 months.
ORR 48.9% for triplet vs 26.0%; median DOR 15.7 vs 7.5 months for alpelisib+fulvestrant.
Grade 3+ TRAEs: neutropenia 58.8% (triplet) vs 0.7%; discontinuation rate 2.6% vs 7.1%.
Company plans sNDA submission following positive PIK3CA MT cohort; PDUFA for NDA in WT cohort July 17, 2026.
Commercial launch expected in Q3 2026 pending FDA approval.

item 7.01 item 8.01 item 9.01

Featured in Daily 8-K Digest

Selected #10 for 2026-06-02. Read digest

Machine-readable event card

schema_version: secwatch.filing_event.v1
accession: 0001493152-26-026761
form_type: 8-K
ticker: CELC
cik: 0001603454
company_name: Celcuity Inc.
filed_at: 2026-06-02T12:10:25+00:00
discovered_at: 2026-06-02T12:15:00.454990+00:00
generated_at: 2026-06-02T12:15:29.188266+00:00
sec_items: ["7.01", "8.01", "9.01"]
event_type: other_material
sentiment: positive
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: high
secwatch_canonical_url: https://secwatch.observer/filing/0001493152-26-026761
json_url: https://secwatch.observer/filing/0001493152-26-026761.json
markdown_url: https://secwatch.observer/filing/0001493152-26-026761.md
text_url: https://secwatch.observer/filing/0001493152-26-026761.txt
edgar_index_url: https://www.sec.gov/Archives/edgar/data/1603454/000149315226026761/0001493152-26-026761-index.htm
edgar_primary_document_url: https://www.sec.gov/Archives/edgar/data/1603454/000149315226026761/form8-k.htm
generated_by_model: deepseek-v4-flash:cloud@v2
review_status: machine_generated
human_reviewed: false
corrected: false
correction_note: null
correction_timestamp: null
superseded_by: null

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