secwatch.observer — SEC 8-K summary
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Issuer:     Celcuity Inc. (CELC)
CIK:        0001603454
Form:       8-K
Filed at:   2026-08-13T20:15:17+00:00
Accession:  0001193125-26-349227
Event type: earnings
Sentiment:  positive
Materiality: 0.90
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Celcuity Q2 net loss $78.9M; FDA approves REVTORPYK, positive PIK3CA MT data
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- FDA approved REVTORPYK (gedatolisib) for HR+/HER2- PIK3CA WT advanced breast cancer on July 14, 2026; launch expected late Q3 2026.
- Phase 3 VIKTORIA-1 PIK3CA MT: gedatolisib triplet cut progression/death risk 50% vs alpelisib (HR=0.50, p<0.0001); median PFS 11.1 vs 5.6 months.
- Q2 2026 net loss $78.9M ($1.44/share) vs $45.3M ($1.04) prior year; adjusted net loss $58.7M ($1.07) vs $40.5M ($0.93).
- Completed $575M convertible notes offering, net proceeds $557.2M; used $137M to prepay term loan debt.
- sNDA for PIK3CA MT cohort planned Q3 2026; VIKTORIA-2 expanded to first-line endocrine-sensitive patients.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1603454/000119312526349227/0001193125-26-349227-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1603454/000119312526349227/celc-20260813.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-349227

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