• Celcuity disclosed Phase 3 VIKTORIA-1 results showing its gedatolisib regimens outperformed a marketed PI3K inhibitor regimen in HR+/HER2- advanced breast cancer.
• The data were scheduled for presentation in a late-breaking oral session at the ASCO Annual Meeting later the same day.
• Both the triplet and doublet regimens extended the time patients lived without disease worsening, with stronger tumor shrinkage, versus the comparator.
• Safety looked more manageable overall, with fewer treatment discontinuations than the comparator, supporting a potential competitive positioning if approved.
• Celcuity plans an FDA supplemental NDA filing, while its separate Priority Review for a wild-type use has a July 17, 2026 PDUFA date.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Celcuity Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001493152-26-026761), on June 02, 2026, and is solely responsible for the information contained therein.