Celcuity Inc. (CELC) — Current Report

AI-Powered SEC Filing Analysis

Latest Current Report Filed: 2026-05-01

Key Insights

Celcuity announced positive Phase 3 VIKTORIA-1 trial results showing gedatolisib plus fulvestrant with or without palbociclib demonstrated statistically significant and clinically meaningful PFS improvement compared to alpelisib in PIK3CA mutant HR+/HER2- breast cancer patients, representing a key milestone for the lead candidate.
The company plans to submit a supplemental NDA (sNDA) to the FDA and present data at the 2026 ASCO Annual Meeting, indicating near-term regulatory action and clinical validation that could accelerate commercialization timelines and market adoption.
Both gedatolisib regimens demonstrated manageable safety profiles with no new safety signals, addressing a critical risk factor for regulatory approval and patient acceptance in the competitive PI3K inhibitor landscape.
The trial's secondary endpoint also met statistical significance for gedatolisib plus fulvestrant alone versus alpelisib plus fulvestrant, potentially expanding the addressable patient population and commercial opportunity beyond the primary analysis.

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Earlier Current Report filings

Filed: 2026-03-25

Celcuity Inc. reported its Q4 and fiscal year 2025 financial results, indicating the company's performance and financial condition for the period.
The company's press release regarding the financial results has been furnished as an exhibit, providing investors with additional information.
Celcuity Inc. is a publicly-traded company, with its common stock listed on the Nasdaq Stock Market.

Filed: 2026-02-12

Celcuity Inc. has appointed Charles (Chip) R. Romp as a new director, expanding the board from seven to eight members.
Mr. Romp qualifies as an independent director and will receive standard non-employee director compensation, including an annual cash retainer and equity award.
There are no known relationships or related transactions between Mr. Romp and the company that would raise concerns.

Other reports for Celcuity Inc.

Insider Trading Annual Report

Important Information

AI-generated analysis is for informational purposes only. Always read original SEC filings and consult with qualified professionals before making investment decisions.