Total
0
Shares
Telix Pharmaceuticals (ASX:TLX) - CEO, Dr Christian Behrenbruch - The Market Herald
CEO, Dr Christian Behrenbruch
Source: Telix Pharmaceuticals [Twitter]
Market Herald logo

Subscribe

Be the first with the news that moves the market
  • 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.

TLX by the numbers
More From The Market Herald
BARD1 Life Sciences (ASX:BD1) - CEO, Leearne Hinch - The Market Herald

" BARD1 Life Sciences (ASX:BD1) updates the market on Q4

BARD1 Life Sciences (BD1) has reported advances across its sales, business development and commercialisation activities over the June quarter.
Incannex Healthcare (ASX:IHL) - Chief Medical Officer, Dr Sud Agarwal (centre) - The Market Herald

" Incannex Healthcare (ASX:IHL) has a progressive fourth quarter

Incannex Healthcare (IHL) has spent the fourth quarter progressing its cannabinoid pharmaceutical products and psychedelic medicine therapies.
Prescient Therapeutics (PTX) - CEO & Managing Director, Steven Yatomi Clarke - The Market Herald

" Prescient Therapeutics (ASX:PTX) advances clinical studies in June quarter

Prescient Therapeutics (PTX) has summarised its operations and cashflow for the June quarter.
Mesoblast (ASX:MSB) - Managing Director & CEO, Silviu Itescu - The Market Herald

" Mesoblast (ASX:MSB) trades lower following June quarterly report

Drug developer Mesoblast (MSB) is trading red following the release of its latest quarterly financial report.