Celcuity Inc. — Form 8-K Summary
Reporting date: September 30, 2026. This current report announces a commercial launch; it does not provide quarterly or annual financial results.
Business context and material event
Celcuity announced that REVTORPYK (gedatolisib) is commercially available in the United States for eligible patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer without a detected PIK3CA mutation, following progression on or after at least one line of endocrine therapy in the metastatic setting. The announcement appears under Items 7.01 and 8.01. The related press release is identified as Exhibit 99.1, but its full text is not included in the provided filing text.
Financial results and liquidity
The filing text provides no revenue, profit or loss, cash flow, margin, debt, liquidity, or other financial metrics. It also provides no comparable-period results.
Guidance, risks, and contingencies
No financial guidance, outlook, management commentary on expected product sales, or specific risks or contingencies are provided in the supplied text. The Item 7.01 information is furnished, not filed for purposes of Exchange Act Section 18.
Investor verification points
- Review Exhibit 99.1 for the full launch announcement, including any details on pricing, access, or commercial expectations.
- Verify the indicated patient population and eligibility criteria against the product labeling and other company disclosures.
- Consult Celcuity’s financial filings for cash, spending, debt, and any quantified impact of the launch.