Celcuity Inc. filings document formal disclosures for a clinical-stage biotechnology company developing targeted oncology therapies. Recent 8-K reports cover gedatolisib and VIKTORIA-1 clinical-trial results in HR+/HER2- advanced breast cancer, FDA-related regulatory updates, financial results, Regulation FD materials, and amendments to a loan and security agreement.
Proxy materials describe annual meeting matters, director elections, auditor ratification, executive compensation votes, stock incentive plans, and employee stock purchase plan amendments. Governance filings also record board composition changes and director compensation arrangements.
Celcuity Inc. (NASDAQ: CELC) filed a Form 144 indicating the intent to sell 9,325 common shares, valued at roughly $420,766 based on the market price when the form was prepared. The shares, which equal about 0.02 % of the 37.9 million shares outstanding, were acquired through two stock-grant awards on 05/14/2022 (7,843 sh) and 05/12/2021 (1,482 sh). No cash consideration was paid for the grants.
The proposed sale is expected on or after 07/28/2025 through broker RBC Capital Markets, with execution on the NASDAQ market. The filer reported no other sales during the past three months and affirmed they possess no undisclosed material adverse information about the company. Form 144 is a notice only; execution is not guaranteed and volume limits under Rule 144 apply.
Given the modest size relative to CELC’s float and the routine nature of insider liquidity events, the filing is unlikely to be material for investors unless accompanied by additional insider activity or negative corporate developments.
Celcuity’s Form 8-K furnishes topline data from the PIK3CA wild-type cohort of its Phase 3 VIKTORIA-1 trial in HR-positive/HER2-negative metastatic breast cancer. Adding gedatolisib to fulvestrant plus palbociclib cut risk of progression or death by 76 % (HR 0.24; p<0.0001) and extended blinded-review median PFS to 9.3 months vs. 2.0 months. The gedatolisib+fulvestrant doublet reduced risk by 67 % (HR 0.33) with mPFS of 7.4 months. Both hazard ratios and incremental PFS gains are the best reported for second-line HR+/HER2- ABC in any Phase 3 study. Discontinuations and class-related AEs (hyperglycemia, stomatitis) were lower than prior Phase 1b data and other approved regimens, indicating an improved tolerability profile.
Celcuity plans to file a New Drug Application with the FDA in Q4 2025; full data will be presented at a medical meeting in 2025. Topline results from the separate PIK3CA-mutant cohort are expected by year-end 2025.