Telix Pharmaceuticals Limited

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Investigation Details

On April 28, 2025, Telix issued a press release announcing that the FDA issued a Complete Response Letter denying approval of Telix’s New Drug Application for TLX101-CDx (“Pixclara”). The FDA indicated “additional confirmatory clinical evidence is required to progress the application.”

Following this news, Telix’s stock price fell by $1.47 per share to open at $17.33 per share.