Coming soon

Ask REGTEKA AI is on its way.

Ask regulatory questions across REGTEKA intelligence.

HomeCompaniesCelcuity

Company

Celcuity

Nasdaq: CELC

Minneapolis, Minnesota biotech, Nasdaq-listed since 2017. REVTORPYK (gedatolisib), FDA-approved July 2026, is its first and only marketed product — a first-in-class pan-PI3K/mTOR inhibitor for PIK3CA-wild-type HR-positive, HER2-negative advanced breast cancer.

1 story

Regulatory News has published 1 story about Celcuity on 2 October 2026, sourced to the primary record — the regulator’s decision, the company’s filing or its own announcement. This page is generated from that coverage. Last updated 2 October 2026.

This page is generated from Regulatory News’ editorial coverage of Celcuity. It is not an advertisement.

On the record

Company
Celcuity, Inc. (Nasdaq: CELC)
Headquarters
Minneapolis, Minnesota
Founded
2012; Nasdaq-listed since 2017
Regulator
U.S. Food and Drug Administration (FDA)

Each line is taken from the most recent story of ours that states it.

Products in our coverage