Telix Pharmaceuticals Limited (NASDAQ: TLX) stock increased significantly as a result of regulatory developments. TLX shares increased 10.26% to $21.50 during Tuesday’s after-hours trading session.
Regulatory Acceptance Drives Stock Increase
The spike comes after the company’s experimental kidney cancer PET imaging agent, TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab), was approved by the US Food and Drug Administration (FDA) in its Biologics License Application (BLA).
With a Prescription Drug User Fee Act (PDUFA) target date of August 27, 2025, the application was given Priority Review, suggesting a possible commercial launch in the United States the following year.
An Advancement in Imaging for Kidney Cancer
The first commercially accessible imaging agent created to precisely and non-invasively identify and characterize clear cell renal cell carcinoma (ccRCC), the most common and aggressive subtype of kidney cancer, would be TLX250-CDx if it is authorized.
The agent works by selectively binding to carbonic anhydrase IX (CAIX), a protein marker that has been shown to be expressed in 95% of cases with ccRCC. High contrast imaging with good tumor-to-background distinction and reliable readings among many doctors are made possible by this focused strategy.
Strong Supports for Clinical Validation The FDA Utilization
The successful worldwide Phase 3 ZIRCON trial, which showed impressive effectiveness measures, including an 86% sensitivity, 87% specificity, and a 93% positive predictive value (PPV) in diagnosing ccRCC, even in tiny and difficult-to-identify lesions, supports Telix’s BLA application.
Professor Brian Shuch and his research team from the University of California, Los Angeles (UCLA) reported these findings in September 2024 in The Lancet Oncology. The study came to the conclusion that TLX250-CDx has the potential to drastically change clinical practice and emphasized the pressing need for a trustworthy, non-invasive diagnostic tool for ccRCC.
Growth of Oncology Imaging Portfolio
Telix Pharmaceuticals is still making inroads in the oncology imaging market. Separately, TLX said that the Luxembourg Agency for Medicines and Health Products (ALMPS) has authorized the distribution of Illuccix, its prostate cancer PET imaging agent.
With this permission, medical professionals in Luxembourg can use PSMA-PET imaging in conjunction with a clinically proven gallium-based radiopharmaceutical to identify and locate lesions in adult patients with prostate cancer that are positive for the prostate-specific membrane antigen (PSMA).