Telix Pharmaceuticals has achieved a significant milestone as the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for Pixclara, a diagnostic agent designed for gliomas, the most common primary brain tumors of the central nervous system. This acceptance grants Pixclara a priority review, setting a decision date on or before April 26, 2025, and potentially positioning it as Telix's second commercialized product.
The company emphasizes the critical unmet need for improved glioma diagnosis and management, particularly in post-treatment settings. Current magnetic resonance imaging (MRI) techniques face limitations, including a lack of biological specificity and an inability to differentiate between tumor progression and treatment-related effects. Pixclara aims to address these shortcomings by providing quicker and more reliable diagnostic information.
Pixclara has been granted FDA orphan drug designation, reflecting its relevance to a market of fewer than 40,000 patients in the U.S., which represents an estimated US$90 million annual market. Telix plans to explore Pixclara's potential application in other central nervous system malignancies.
Telix's first FDA approval was for Illucix, a prostate cancer imaging agent, in December 2021. Illucix has since captured approximately 35% of the prostate imaging market, with third-quarter sales reaching US$135 million, primarily from U.S. sales. The company has affirmed its calendar year 2024 revenue guidance of US$490-510 million.
While the FDA previously rejected Telix's NDA filing for Zircaix, an imaging agent for clear cell renal carcinoma, due to relatively minor issues, the company is on track to resubmit the application in November and continues to target a full U.S. commercial launch in 2025. However, Pixclara may reach the market slightly earlier.
Telix is also conducting therapeutic trials for both recurring glioblastoma and new patients, alongside Phase II and pre-clinical kidney combination trials with clinical data expected later this year.
