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Telix Pharmaceuticals (ASX:TLX) - CEO, Christian Behrenbruch
CEO, Christian Behrenbruch
Source: Telix Pharmaceuticals/Twitter
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  • The FDA finds no substantive review issues with Telix Pharmaceuticals’ (TLX) lead investigational product, Illuccix, following a late-cycle review meeting
  • Illuccix has already been accepted for filing by the US FDA and is under priority evaluation by the Australian Therapeutic Goods Administration
  • The company is also progressing marketing applications for its product in the European Union and Canada
  • Telix says it will continue developing a portfolio of clinical-stage products to address currently unmet medical need in oncology and rare diseases.
  • Telix Pharmaceuticals last traded at $5.62 on June 17

The FDA has found no substantive review issues with Telix Pharmaceuticals’ (TLX) lead investigational product, Illuccix.

The Melbourne-based company sat down with the US Food and Drug Administration (FDA) for a late-cycle review meeting for the ongoing review of the application for its prostate cancer imaging investigational product, Illuccix.

During the meeting, the FDA indicated there are no substantive review issues with Telix’s submission.

Illuccix has already been accepted for filing by the US FDA and is under priority evaluation by the Australian Therapeutic Goods Administration. Telix is also progressing marketing applications for its product in the European Union and Canada.

“The late-cycle review meeting with the FDA continued a series of productive meetings with the agency and sets the stage for the concluding phase of the NDA review process, including alignment on the final Illuccix product label,” said Telix Chief Executive Officer, Dr, Christian Behrehbruch.

“We remain optimistic about a positive outcome and, accordingly, are working closely with our commercial partners to prepare for the U.S. launch of Telix’s lead product for prostate cancer imaging, pending approval.”

The company says delivering patient access to important technology to support the management of prostate cancer remains a major corporate objective for Telix.

Telix says it will continue developing a portfolio of clinical-stage products to address currently unmet medical need in oncology and rare diseases.

Telix Pharmaceuticals last traded at $5.62 on June 17.

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