Celcuity Achieves Major Regulatory Milestone with FDA Submission

Celcuity Inc. has reached a pivotal moment in its corporate trajectory, announcing the submission of a New Drug Application to the U.S. Food and Drug Administration for its cancer therapeutic candidate, Gedatolisib. This regulatory advancement coincides with the company revealing a stronger-than-anticipated financial position, providing a multi-year operational runway.

On November 17, Celcuity formally submitted its application for Gedatolisib targeting advanced breast cancer. The submission carries significant weight as the FDA will review it under its Real-Time Oncology Review (RTOR) program. This accelerated pathway is designated for promising therapies that demonstrate substantial improvements over existing treatment options. A regulatory decision is projected for 2026.

The application leverages compelling data from Read more...