Nuclear medicine guidelines include Telix’s renal imaging agent

MELBOURNE/INDIANAPOLIS - Telix Pharmaceuticals Limited (ASX:TLX, NASDAQ: TLX), a $3.68 billion market cap healthcare company with impressive 55% revenue growth over the last twelve months, announced Thursday that its investigational PET imaging agent for kidney cancer, TLX250-CDx, has been included in updated clinical guidelines from three major nuclear medicine societies. According to InvestingPro data, the company maintains a healthy 54% gross profit margin.

The guidelines, jointly issued by the Society of Nuclear Medicine and Molecular Imaging, European Association of Nuclear Medicine, and American College of Nuclear Medicine, recognize the use of TLX250-CDx (89Zr-DFO-girentuximab) for molecular imaging of renal masses.

According to the expert panel that developed the guidelines, TLX250-CDx appears to be "a well-tolerated and accurate method for non-invasive identification" of clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer.

The panel cited data from Telix’s Phase 3 ZIRCON trial, which demonstrated 86% sensitivity, 87% specificity, and 93% positive predictive value for detecting ccRCC, including in small, difficult-to-detect lesions. InvestingPro analysis shows strong analyst confidence in Telix’s potential, with a consensus recommendation of 1.2 (Strong Buy). Subscribers can access 10+ additional ProTips and detailed financial metrics.

TLX250-CDx works by binding to carbonic anhydrase IX, a protein expressed in over 95% of ccRCC cells, producing high-contrast images with consistent readability.

"The inclusion of TLX250-CDx PET imaging in these guidelines is an important development for Telix and will help raise awareness of this breakthrough precision diagnostic," said Kevin Richardson, Chief Executive Officer of Precision Medicine at Telix, in the press release.

The company noted that subject to regulatory approval, this endorsement could help drive clinical adoption and implementation into treatment workflows.

TLX250-CDx has not yet received marketing authorization in any jurisdiction. The announcement follows Telix’s recent FDA approval for Gozellix, the company’s second-generation PSMA-PET imaging agent. InvestingPro data indicates the company is currently trading at Fair Value, with analysts setting price targets between $19.78 and $22.13, suggesting potential upside for investors watching this space.

In other recent news, Telix Pharmaceuticals Limited has dosed the first patient in its Phase 1 clinical trial of TLX090, aimed at treating pain from bone metastasis. This trial, named SOLACE, will involve up to 33 patients and focuses on evaluating the safety and effectiveness of the radiopharmaceutical candidate. Additionally, Telix has initiated a Phase 3 trial to expand the use of its Illuccix and Gozellix imaging agents for prostate cancer diagnosis, combining MRI and PSMA-PET imaging for potentially improved diagnostic accuracy.

However, the company faced a setback when the FDA issued a Complete Response Letter for its TLX250-CDx, citing deficiencies in the Chemistry, Manufacturing, and Controls package. The FDA has requested more data to ensure the comparability of the clinical trial drug product with the intended commercial version. In light of these developments, H.C. Wainwright has lowered its price target for Telix Pharmaceuticals to $20 from $23, while maintaining a Buy rating. These events mark significant recent developments for Telix Pharmaceuticals.

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