Shares in Telix Pharmaceuticals experienced a significant downturn on Thursday, plummeting 17 per cent, following the receipt of a “complete response” letter from the US Food and Drug Administration (FDA). The letter pertains to clinical trials for Telix’s new kidney cancer diagnostic agent, indicating that the FDA requires further information before potential approval.
Telix stated that the FDA is seeking additional data related to its phase three clinical trials and the manufacturing processes intended for commercial use of the diagnostic agent. The company also revealed that the FDA had documented deficiencies issued to two third-party manufacturing and supply chain partners. These deficiencies will need to be addressed and resolved before Telix can resubmit its application for approval.
Despite this setback, Telix has affirmed that the FDA’s request will not impact its revenue guidance for 2025. Telix Pharmaceuticals is a global biopharmaceutical company focused on the development of diagnostic and therapeutic products using molecularly targeted radiation. The company is headquartered in Melbourne, Australia, with international operations in the United States, Europe, and Japan.
This news comes after a previous announcement last month that the US Securities and Exchange Commission had issued a subpoena to Telix, requesting information related to disclosures concerning the development of the company’s prostate cancer therapies. Since that initial announcement, Telix’s shares have fallen almost 40 per cent.
