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SEC EDGAR 8-KAUG 137 min read$CELC

Celcuity Inc. (CELC): Results of Operations and Financial Condition

Celcuity Inc. (CELC) filed an SEC Form 8-K — Results of Operations and Financial Condition. EX-99.1 2 celc-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Celcuity Inc. Reports Release of Second Quarter 2026 Financial Results and Provides Corporate Update • REVTORPYK™ (gedatolisib) approved by the U.S. FDA for the treatment of HR+/HER2- PIK3CA Wild-Type locally advanced or meta

Original reporting
SEC EDGAR 8-K
Published Aug 13, 2026, 8:15 PM UTC
Analysis
alphai AI DeskAI-generated
Added to alphai Aug 13, 2026, 8:19 PM UTC. Informational, not investment advice.
How this was made
alphai summarizes source reporting and applies a structured AI analysis for relevance, timing, sentiment and ticker impact. Always verify material claims with the original publisher.
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alphai market briefEarnings
Primary signal
$CELC
Bullish
high confidence
Mentioned
$CELC
Relevance
8/10
alphai data visualization · based on SEC EDGAR 8-K
Decision brief

The 30-second read

$CELCBullishMed
01

Why it matters

The most tradable elements are the FDA approval date, NCCN Category 1 positioning, expected shipment timing late Q3 2026, and quantified VIKTORIA-1 PIK3CA mutant cohort outcomes that underpin an sNDA planned for Q3 2026.

02

Market read

Traders can update models for CELC based on FDA approval, NCCN Category 1 recommendation, and commercialization timeline, plus quantified Phase 3 efficacy and safety discontinuation rates.

03

What to watch

The text emphasizes shipment start and planned sNDA, but does not provide revenue guidance, launch economics, or detailed financial metrics in the excerpt, which could temper near-term expectations.

Relevance 8/10Novelty 8/10Timing: after-hours filing and webcast today at 4:30 p.m. EDT

Background

This is an SEC 8-K (Item 2.02) with an exhibit announcing Q2 2026 financial results and major clinical and regulatory updates for gedatolisib (REVTORPYK).

Company-level read

Ticker impact

$CELCBullishHigh confidence
Context

Celcuity reports Q2 2026 results and says FDA approved REVTORPYK on July 14, 2026, with shipments expected late Q3 2026.

Expected impact

Bullish bias with potential volatility around the planned sNDA submission in Q3 2026 and ongoing label/data updates.

Evidence & confidence

The filing is a primary disclosure (8-K with exhibit) containing FDA approval status, NCCN Category 1 recommendation, shipment timing, and quantified VIKTORIA-1 PIK3CA MT efficacy and safety discontinuation rates.

Market effects

Sector

Supports sentiment for targeted oncology and pan-PI3K/mTOR pathway assets, potentially improving read-through for similar breast cancer programs.

Regional

Limited direct regional spillover; primarily US biotech sentiment tied to FDA and NCCN updates.

Global

Moderate, as VIKTORIA-1 is global and sNDA/other-regulator submissions are planned, but the immediate catalyst is US commercialization.

Counterpoint

What could challenge this read

Approval and positive endpoints may already be partially priced; investors may focus on commercial execution risks and the timeline to sNDA acceptance.

Key entities

  • company
    Celcuity Inc.

    Nasdaq-listed biotech developing and commercializing targeted therapies; subject of the 8-K.

  • product
    REVTORPYK (gedatolisib)

    Pan-PI3K, mTORC1/2 inhibitor approved by the FDA for HR+/HER2- PIK3CA wild-type advanced breast cancer.

  • clinical_trial
    VIKTORIA-1

    Phase 3 program; PIK3CA mutant cohort achieved primary endpoint and supports planned sNDA submission.

  • clinical_trial
    VIKTORIA-2

    Phase 3 trial expanded to evaluate gedatolisib as first-line in endocrine-sensitive HR+/HER2+ advanced breast cancer.

  • financing
    Convertible note offering

    Company completed a $575.0 million convertible note offering with $557.2 million net proceeds.

Read at source← All news

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