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The latest announcement is out from Telix Pharmaceuticals ( (AU:TLX) ).
Telix Pharmaceuticals has reached an agreement with the U.S. FDA on the resubmission pathway for its New Drug Application for TLX101-CDx, an investigational imaging agent for glioma, a rare brain cancer. The company plans to resubmit the NDA in Q4 2025, following detailed feedback from the FDA, which includes conducting an additional confirmatory efficacy study. The FDA has acknowledged the unmet medical need and indicated that an expedited review is likely, although TLX101-CDx is not included in Telix’s 2025 revenue guidance as it remains an unapproved product.
The most recent analyst rating on (AU:TLX) stock is a Hold with a A$16.50 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 Limited is a biopharmaceutical company focused on developing and commercializing therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Headquartered in Melbourne, Australia, Telix operates internationally in the United States, United Kingdom, Brazil, Canada, Europe, and Japan. The company is listed on the Australian Securities Exchange and the Nasdaq Global Select Market, with a portfolio aimed at addressing significant unmet medical needs in oncology and rare diseases.
YTD Price Performance: -43.93%
Average Trading Volume: 2,361,186
Technical Sentiment Signal: Sell
Current Market Cap: A$4.67B
See more data about TLX stock on TipRanks’ Stock Analysis page.