Celcuity Inc. (CELC) Stock: Slides 16% as FDA Clears REVTORPYK for Breast Cancer

Table of Contents

TLDR

Celcuity stock falls 16% despite FDA approval of REVTORPYK for breast cancer.
FDA clears REVTORPYK as Celcuity advances targeted cancer treatment plans.
CELC shares decline after major approval milestone for advanced breast cancer drug.
REVTORPYK shows strong trial results before Celcuity’s planned 2026 launch.
Celcuity expands oncology pipeline after securing first FDA-approved therapy.

Celcuity Inc. (NASDAQ: CELC) shares fell 16.23% to $93.03 despite securing a major regulatory milestone. The stock declined sharply after the opening bell before recovering modestly and stabilizing below its opening level. Meanwhile, the U.S. Food and Drug Administration approved REVTORPYK for a specific group of advanced breast cancer patients.

Celcuity Inc., CELC

FDA Approval Expands Treatment Options for HR+/HER2- Breast Cancer

The FDA approved REVTORPYK, also known as gedatolisib, for HR-positive and HER2-negative advanced or metastatic breast cancer. The approval covers patients without a PIK3CA mutation after disease progression following endocrine therapy.Celcuity gained its first approved commercial therapy.

REVTORPYK became the first FDA-approved inhibitor targeting all class I PI3K isoforms together with mTORC1 and mTORC2. The therapy targets the PI3K/AKT/mTOR signaling pathway linked to cancer growth. The approval addresses a long-standing challenge in developing broad pathway inhibitors.

HR-positive and HER2-negative disease represents about 70% of breast cancer cases. Furthermore, around 60% of those patients have PIK3CA wild-type disease. The approval targets a large patient population with limited treatment choices after endocrine therapy.

Phase 3 Trial Results Supported the FDA Decision

The FDA based its decision on results from the Phase 3 VIKTORIA-1 clinical trial. The global study evaluated REVTORPYK with fulvestrant, both with and without palbociclib.The trial enrolled patients whose disease progressed after CDK4/6 inhibitor treatment and aromatase inhibitor therapy.

The REVTORPYK triplet achieved median progression-free survival of 9.3 months compared with 2.0 months for fulvestrant alone. The treatment also produced a 32% objective response rate. The median duration of response reached 17.5 months.

The REVTORPYK doublet delivered median progression-free survival of 7.4 months against 2.0 months for fulvestrant. The doublet achieved a 28% objective response rate and a 12.0-month median response duration. Both treatment combinations demonstrated significant clinical improvements during the study.

Commercial Launch Plans and Broader Development Continue

Celcuity expects to launch REVTORPYK commercially during late third quarter 2026. Eligible patients can access the therapy through the company’s expanded access program before launch. The company also plans patient support services to improve treatment availability.

The company intends to submit a supplemental New Drug Application during the third quarter of 2026. The filing seeks approval for patients with PIK3CA-mutated HR-positive and HER2-negative advanced breast cancer. The submission relies on positive results from another VIKTORIA-1 study cohort.

Celcuity also plans regulatory submissions in international markets using VIKTORIA-1 data.The ongoing Phase 3 VIKTORIA-2 program continues evaluating REVTORPYK in treatment-naive advanced breast cancer patients. The company continues expanding the therapy’s potential across multiple patient groups while advancing its oncology pipeline.

Go back