Welcome to our dedicated page for Celcuity SEC filings (Ticker: CELC), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The Celcuity Inc. (NASDAQ: CELC) SEC filings page provides access to the company’s official regulatory disclosures as a clinical-stage biotechnology company developing targeted therapies for oncology. Through these documents, investors can review how Celcuity reports its progress with gedatolisib, a multi-target PI3K/AKT/mTOR (PAM) inhibitor being evaluated in multiple solid tumor indications, including HR+/HER2- advanced breast cancer and metastatic castration resistant prostate cancer.
Celcuity’s recent Form 8-K filings highlight material clinical and regulatory events, such as detailed results from the Phase 3 VIKTORIA-1 trial in HR+/HER2-/PIK3CA wild-type advanced breast cancer, updates on the fully enrolled PIK3CA mutant cohort, and clinical data from early phase studies of gedatolisib in combination with darolutamide. Other 8-Ks describe the submission of a New Drug Application (NDA) to the U.S. FDA for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer under the Real-Time Oncology Review program, as well as quarterly financial results and corporate updates.
Filings also detail financing and capital structure transactions, including public offerings of common stock and pre-funded warrants, issuance of 2.750% Convertible Senior Notes due 2031, and amendments to Celcuity’s senior secured term loan facility with lenders such as Oxford Finance LLC and Innovatus Life Sciences Lending Fund I, LP. These documents describe new term loan tranches, warrant issuances, and conditions tied to regulatory milestones and product revenue thresholds.
On Stock Titan, users can track Celcuity’s SEC filings as they are posted to EDGAR and use AI-powered summaries to quickly interpret key points from lengthy reports. This includes understanding the implications of 8-K event disclosures, financial condition updates, loan agreement amendments, and equity or debt offerings related to the company’s efforts to advance and potentially commercialize gedatolisib.
CELC filed a Form 144 notice reporting an intended sale of 6,000 shares of Common Stock tied to an option exercise, with the transaction dated 05/04/2026. The filing also states 3,000 shares were sold during the past three months on 03/31/2026 for $330,804. The plan is labeled as equity compensation and the broker listed is Stifel Nicolaus & Company Inc.
Celcuity Inc. reported positive topline Phase 3 results from the PIK3CA mutant cohort of its VIKTORIA-1 trial in HR+/HER2- advanced breast cancer. Gedatolisib plus fulvestrant, with or without palbociclib, showed a statistically significant and clinically meaningful improvement in progression-free survival versus alpelisib plus fulvestrant and was generally well tolerated.
The company plans to submit these data as a supplemental New Drug Application to the FDA and then to other regulators, and to present detailed results in a late-breaking oral session at the 2026 ASCO Annual Meeting. An existing NDA for gedatolisib in PIK3CA wild-type disease is already under FDA Priority Review with a PDUFA goal date of July 17, 2026.
Celcuity Inc. director Richard Nigon reported a bona fide gift of 10,000 shares of Common Stock on April 9, 2026. The transfer was recorded at no cash consideration, reflecting a charitable or personal gift rather than a market sale. After the transaction, he directly holds 79,035 Celcuity shares.
Celcuity Inc. is asking stockholders at its May 14, 2026 annual meeting to elect eight directors, ratify Boulay PLLP as independent auditor, approve executive compensation on an advisory basis, and adopt two updated equity plans.
The company seeks approval of a new 2026 Stock Incentive Plan covering 3,000,000 shares, which will replace the existing 2017 stock plan for new grants and includes an annual share “evergreen” increase of up to 1.0% of common stock from 2027 through 2036. It also discloses an average three-year equity grant burn rate of 4.4% and a fully diluted overhang of 18.2% as of March 17, 2026.
Celcuity further proposes an amended and restated 2017 Employee Stock Purchase Plan, increasing the share pool by 289,199 to a total authorization of 1,229,370 shares and extending the ESPP term by ten years, with a standard Section 423 structure and a 15% purchase discount. As of March 17, 2026, there were 48,336,675 common shares outstanding, each entitled to one vote on these proposals.
Celcuity Inc. director Richard E. Buller reported an option exercise and related stock sales by a family trust. On March 31, 2026, a trust for which he and his spouse are trustees exercised 3,000 stock options at $5.10 per share into common stock.
The trust then sold 2,325 Celcuity common shares at a weighted average price of $110.1057 and 675 shares at a weighted average price of $110.8268 in open-market transactions, totaling 3,000 shares sold. These trades and the option exercise were carried out under a pre-arranged Rule 10b5-1 trading plan adopted on December 8, 2025. After the transactions, the trust held 6,760 shares of common stock, and Buller also held 1,029 shares directly.
Celcuity Inc. is a clinical-stage biotech focused on targeted therapies for solid tumors, led by its pan‑PI3K/mTOR inhibitor gedatolisib for HR+/HER2‑ advanced breast cancer and metastatic castration‑resistant prostate cancer. More than 1,100 people have received gedatolisib across completed and ongoing trials.
The Phase 3 VIKTORIA‑1 breast cancer trial enrolled 754 patients and showed that gedatolisib triplet and doublet regimens delivered large, statistically significant progression‑free survival benefits versus fulvestrant, including in PIK3CA wild‑type tumors. Gedatolisib has Fast Track and Breakthrough Therapy designations, is under Real‑Time Oncology Review, and its NDA has Priority Review with a July 17, 2026 PDUFA goal date.
Celcuity estimates a U.S. second‑line breast cancer market opportunity of more than $5.0 billion annually and potential peak revenue up to $2.5 billion if approved for both PIK3CA wild‑type and mutant populations. The company licenses gedatolisib from Pfizer, with up to $335.0 million in potential milestones and low‑ to mid‑teen royalties.
Celcuity Inc. reported fourth quarter and full year 2025 results alongside major regulatory and clinical milestones for its lead drug candidate, gedatolisib.
The FDA accepted Celcuity’s New Drug Application for gedatolisib in HR+/HER2- PIK3CA wild-type advanced breast cancer, granted Priority Review, and set a PDUFA goal date of July 17, 2026. Published Phase 3 VIKTORIA-1 cohort data showed the gedatolisib triplet improved median time to definitive deterioration in patient-reported well-being to 23.7 months versus 4.0 months on fulvestrant, with a hazard ratio of 0.39.
Total operating expenses rose to $49.2 million in the fourth quarter and $172.2 million for 2025, driving a GAAP net loss of $51.0 million for the quarter and $177.0 million for the year. Non-GAAP adjusted net loss was $38.4 million for the quarter and $150.8 million for 2025. Cash, cash equivalents and short-term investments were $441.5 million at year-end 2025, which the company expects will fund operations through 2027.
Baker Bros. Advisors and related entities filed an amended Schedule 13D for Celcuity Inc., reporting beneficial ownership of 9,582,874 shares of common stock, representing 19.99% of the class. This percentage is based on 46,271,259 shares outstanding as of November 6, 2025 plus 1,667,082 shares underlying $0.001 prefunded warrants exercisable within 60 days. On March 20, 2026, the funds notified Celcuity that they were increasing the beneficial ownership limitation on 481,437 and 5,666,350 $0.001 prefunded warrants held by 667 and Baker Brothers Life Sciences, respectively, from 4.99% to 19.99%, effective May 20, 2026. The reporting persons state they did not acquire additional securities in connection with this change and continue to hold their position for investment purposes, while reserving flexibility to buy or sell Celcuity securities in the future.