Celcuity Scores FDA RTOR Acceptance as VIKTORIA-1 Data Bolster gedatolisib Prospects

Introduction

Celcuity Inc. (NASDAQ: CELC) is a clinical-stage biotechnology company headquartered in Minneapolis, Minnesota. The firm develops targeted therapies for multiple solid tumors by inhibiting the PI3K/AKT/mTOR (PAM) pathway. Its lead product candidate, gedatolisib, is a pan-PI3K and mTORC1/2 inhibitor designed to comprehensively blockade this oncogenic pathway.

As of October 20, 2025, shares of CELC traded on the NASDAQ at $79.14, reflecting a 52.31% increase year-to-date; daily volume stood at 641,944.

Corporate Structure and Team

Celcuity employs between 51 and 200 professionals, including drug development scientists, biochemists, and molecular biologists. The company operates from its Minneapolis headquarters at 16305 36th Avenue North, where cross-functional teams oversee discovery, clinical development, and regulatory strategy.

Biotechnology by Louis Reed

Recent Developments and News

• August 14, 2025: Celcuity held a webcast and conference call to release its second-quarter 2025 financial results.
• August 2025: The U.S. Food and Drug Administration accepted Celcuity’s New Drug Application for gedatolisib under the Real-Time Oncology Review (RTOR) program.
• September 2025: Celcuity initiated a rolling submission of its NDA, with completion anticipated in the fourth quarter of 2025.
• October 20, 2025, at 8:00 a.m. ET: The company presented additional topline data from the PIK3CA wild-type cohort of its Phase 3 VIKTORIA-1 trial in hormone receptor-positive, HER2-negative advanced breast cancer.
• Ongoing trials:
  • VIKTORIA-2 Phase 3 (gedatolisib plus CDK4/6 inhibitor and fulvestrant in first-line HR+/HER2- advanced breast cancer).
  • CELC-G-201 Phase 1/2 (gedatolisib plus darolutamide in metastatic castration-resistant prostate cancer).

Financial and Strategic Analysis

Celcuity’s market capitalization stands at approximately $2.2 billion, with an enterprise value near $2.03 billion. Key metrics as of October 17, 2025:

• Net loss: $148.7 million (EPS: –3.47)
• Total cash: $168.4 million
• Total debt/equity ratio: 224%
• Levered free cash flow: –$73.7 million
• Beta (5-year): 0.71

To support late-stage development and prepare for potential commercialization, the company expanded its senior secured credit facility to $500 million. Gedatolisib holds Breakthrough Therapy and Fast Track designations.

Market Position and Industry Context

Celcuity focuses on cancers driven by the PAM pathway, including breast, prostate, lung, endometrial, colon, and ovarian tumors. Competitors may target individual nodes of this pathway, while gedatolisib aims for comprehensive blockade of all four Class I PI3K isoforms and both mTORC complexes. Positive Phase 3 data and an RTOR-accelerated review position Celcuity to potentially influence treatment standards in HR+/HER2- advanced breast cancer, pending FDA approval and evidence of progression-free survival benefits.

tl;dr

• On October 20, 2025, Celcuity presented additional Phase 3 VIKTORIA-1 results for its gedatolisib regimen in HR+/HER2- advanced breast cancer.
• The FDA accepted the NDA for gedatolisib under the RTOR program in August 2025; rolling submission is expected to conclude in Q4 2025.
• The company expanded its senior secured credit facility to $500 million to support late-stage trials and potential market launch.
• Enrollment continues in the Phase 3 VIKTORIA-2 and Phase 1/2 CELC-G-201 studies, with readouts and regulatory milestones anticipated through year-end.