Ready 8-Ks
17
Latest filing
May 20, 2026 11:30 UTC
Top materiality
0.95
Event mix
other_material ×8 · earnings ×4 · leadership ×2
Sentiment
10 pos · 0 neg · 7 neu
Latest earnings
reported 2025-Q3
-
May 14, 2026 20:05 UTC
earnings
materiality 0.85
positive
item 2.02item 9.01
Celcuity reports Q1 net loss $52.8M; VIKTORIA-1 hits primary endpoint in PIK3CA mutant
Net loss $52.8M ($0.97/share) vs $37.0M ($0.86/share) in Q1 2025; non-GAAP adjusted net loss $46.8M ($0.86).
-
May 01, 2026 23:59 UTC
other_material
materiality 0.85
positive
item 7.01item 8.01item 9.01
Celcuity Phase 3 VIKTORIA-1 PIK3CA mutant cohort meets primary endpoint with significant PFS improvement
Gedatolisib triplet (plus fulvestrant and palbociclib) showed statistically significant PFS improvement vs alpelisib+fulvestrant.
-
Mar 25, 2026 23:59 UTC
earnings
materiality 0.85
positive
item 2.02item 9.01
Celcuity reports Q4 loss $0.97/share; FDA grants Priority Review for gedatolisib, PDUFA July 17, 2026
Net loss Q4 $51.0M ($0.97), FY $177.0M ($3.79); adjusted net loss Q4 $38.4M ($0.73), FY $150.8M ($3.22).
-
Nov 17, 2025 23:59 UTC
regulatory
materiality 0.90
positive
item 7.01item 8.01item 9.01
Celcuity completes NDA submission to FDA for gedatolisib in HR+/HER2- advanced breast cancer under RTOR program
NDA submitted for gedatolisib in HR+/HER2-, PIK3CA wild-type advanced breast cancer.
-
Nov 12, 2025 23:59 UTC
earnings
materiality 0.65
neutral
item 2.02item 9.01
Celcuity Q3 net loss $43.8M; gedatolisib NDA on track for Q4 2025
Q3 net loss $43.8M ($0.92 loss per share) vs $29.8M ($0.70 loss) in prior year.
-
Oct 20, 2025 23:59 UTC
other_material
materiality 0.90
positive
item 7.01item 8.01item 9.01
Phase 3 VIKTORIA-1 data: gedatolisib triplet reduces progression risk by 76% in HR+/HER2- ABC
Median PFS 9.3mo for gedatolisib triplet vs 2.0mo for fulvestrant (HR=0.24); incremental 7.3mo improvement.
-
Sep 10, 2025 23:59 UTC
debt
materiality 0.85
positive
item 1.01item 2.03item 3.02item 7.01item 9.01
Celcuity upsizes senior secured facility to $500M, receives $30M immediate funding
Total facility increased to $500M ($350M committed + $150M discretionary); $30M funded, total outstanding $130M.
-
Aug 14, 2025 23:59 UTC
earnings
materiality 0.85
positive
item 2.02item 9.01
Celcuity reports Phase 3 gedatolisib milestone; NDA filing on track for Q4 2025
Phase 3 VIKTORIA-1: gedatolisib triplet reduced risk of progression/death by 76% (HR=0.24); median PFS 9.3 mo vs 2.0 mo.
-
Aug 01, 2025 23:59 UTC
debt
materiality 0.75
neutral
item 1.01item 2.03item 8.01item 9.01
Celcuity issues $201.25M of 2.750% convertible notes due 2031; net proceeds ~$194.5M
Issued $201.25M aggregate principal of 2.750% Convertible Senior Notes due 2031; initial conversion price ~$51.30/share.
-
Jul 31, 2025 23:59 UTC
other_material
materiality 0.70
neutral
item 1.01item 8.01item 9.01
Celcuity prices $175M convertible notes and stock offering; net proceeds ~$248.7M
$175M of 2.750% convertible senior notes due 2031 priced; initial conversion price ~$51.30/share (35% premium to stock offering).
-
Jul 29, 2025 23:59 UTC
other_material
materiality 0.85
neutral
item 1.01item 8.01item 9.01
Celcuity launches $150M convertible notes + $75M common stock offerings; also to draw $30M loan
Concurrent underwritten offerings: $150M convertible notes due 2031 and $75M common stock; 30-day over-allotment options for additional $22.5M notes and $11.25M stock.
-
Jul 28, 2025 23:59 UTC
other_material
materiality 0.95
positive
item 7.01item 8.01item 9.01
Celcuity Phase 3 VIKTORIA-1 PIK3CA wild-type: gedatolisib triplet cuts progression/death risk by 76% (HR 0.24)
Gedatolisib triplet (plus palbociclib/fulvestrant) mPFS 9.3 mo vs 2.0 mo for fulvestrant, incremental gain 7.3 mo.
-
Jun 30, 2025 23:59 UTC
other_material
materiality 0.75
positive
item 7.01item 8.01item 9.01
Celcuity reports 66% six-month rPFS in mCRPC Phase 1, 43% ORR in HER2+ mBC Phase 2
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.