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Highlights

  • Telix shares fall 6% after FDA refuses approval of Pixclara imaging agent.

  • FDA requests additional clinical data, citing the current application as insufficient.

  • Despite setback, Telix shares remain up 9.7% year-to-date.

Shares of Telix Pharmaceuticals Ltd (ASX:TLX) tumbled on Monday after the company announced that the U.S. Food and Drug Administration (FDA) had rejected its new drug application (NDA) for Pixclara, an experimental imaging agent designed for detecting glioma.

By mid-morning trade, Telix shares had dropped 6% to AU$26.86, their lowest level since 14 April 2025. Earlier in the session, the stock plunged as much as 9.3%, marking its steepest intraday fall since 7 April 2025. Telix was among the biggest percentage losers on the S&P/ASX 200 Index (ASX: XJO) today.

The biotech company revealed that the FDA determined the current application for Pixclara could not be approved as submitted. Regulators have requested additional clinical evidence to advance the application, a move that significantly delays Telix's hopes of bringing the imaging agent to market in the near term.

Pixclara was developed as a diagnostic tool for imaging gliomas, a type of tumor that arises in the brain or spine. It was seen as an important addition to Telix’s growing portfolio of imaging and therapeutic products. The setback with the FDA has cast uncertainty over the timeline for the potential commercialisation of the product in the U.S. market.

Telix acknowledged the FDA's feedback and said it is assessing the required next steps. While the refusal represents a hurdle, the company emphasised its commitment to continuing engagement with the regulator and gathering the necessary data to address the FDA’s concerns.

Despite today's sharp fall, Telix shares remain 9.7% higher for the year to date, reflecting broader investor optimism around the company’s pipeline and its already-approved imaging products.

The FDA’s request for additional evidence typically suggests that while there are no safety concerns preventing approval, the current clinical data may be insufficient to meet regulatory standards. This means that with additional work, Telix could still pursue approval without having to restart the process entirely.