Telix Advances Precision Imaging Portfolio With Strong China Trial Data and FDA Progress

Telix Pharmaceuticals ( (AU:TLX) ) has issued an announcement.

Telix Pharmaceuticals reported strong top-line Phase 3 data from its Illuccix (TLX591-CDx) prostate cancer imaging trial in Chinese patients, with a patient-level positive predictive value of 94.8% and treatment plans altered in more than two-thirds of participants, paving the way for a near-term New Drug Application in China’s rapidly expanding prostate cancer and nuclear medicine market in partnership with Grand Pharma. The company also outlined progress on U.S. regulatory pathways for its other imaging agents, with an NDA resubmission for glioma PET tracer TLX101-CDx being finalised following constructive FDA feedback, and alignment reached with the FDA on addressing chemistry, manufacturing and controls issues for TLX250-CDx, including an additional meeting in January to confirm data requirements for commercial-scale manufacturing comparability, underscoring Telix’s efforts to stabilise and expand its precision medicine portfolio while maintaining expanded access programs for patients.

The most recent analyst rating on (AU:TLX) stock is a Buy with a A$34.00 price target. To see the full list of analyst forecasts on Telix Pharmaceuticals stock, see the AU:TLX Stock Forecast page.

More about Telix Pharmaceuticals

Telix Pharmaceuticals is an Australia-based biopharmaceutical company focused on precision oncology, developing and commercialising PET imaging and radiopharmaceutical agents such as Illuccix (TLX591-CDx) for prostate cancer, TLX101-CDx (Pixclara) for glioma, and TLX250-CDx (Zircaix) for clear cell renal cell carcinoma, with a growing presence in key markets including the United States, China and Greater China through partners like Grand Pharmaceutical Group.

YTD Price Performance: -51.93%

Average Trading Volume: 1,982,103

Technical Sentiment Signal: Sell

Current Market Cap: A$4.01B

See more data about TLX stock on TipRanks’ Stock Analysis page.