Telix Pharmaceuticals Gets US FDA Nod to Advance Phase 3 Prostate Cancer Trial
MT Newswires Live
Jul 02
Telix Pharmaceuticals (ASX:TLX) reached alignment with the US Food and Drug Administration (FDA) to advance a phase 3 trial of its TLX591-Tx therapeutic candidate in metastatic castration-resistant prostate cancer, the company said Thursday.
In a type B meeting, the US regulator confirmed that safety data from part one of the study is adequate to allow for progression of part two, the company said.
The launch of part two in the US remains subject to the FDA's review of an investigational new drug amendment, per the statement.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.