Shares in Melbourne-based oncology company Telix Pharmaceuticals Ltd (ASX: TLX) are currently down 2% in the red today, trading at $7.35 apiece.
Investors aren't responding enthusiastically to a company announcement early on during Friday's session concerning regulatory approval of its Illuccis label.
Following the update, Illuccix has successfully progressed to the final stage of regulatory assessment in Europe. Here are the details.
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What did Telix announce?
Telix advised that its marketing authorisation application (MAA) submission in Europe for the registration of its lead product Illuccix has successfully progressed to the final stage of regulatory assessment.
Illuccix is indicated for use in prostate cancer imaging, and has already been approved by the Australian Therapeutic Goods Administration (TGA), and accepted for filing by the U.S. Food and Drug Administration (FDA).
Hence approval in the European, Middle East and Africa (EMEA) zones is a high watermark that would round out Telix's Illuccix offering on a global scale, considering its approval in Australia and potentially the US.
The release notes that after a comprehensive review process, an "approval decision notification" of the product's registration status in Europe is expected to be provided no later than 23 March 2022.
According to Telix, the evaluation of Illuccix has been led by The Danish Medicines Agency (DKMA) in its capacity as a Reference Member State (RMS). It is doing so on behalf of 13 European countries and the United Kingdom.
These are the initial territories that were selected by Telix for MAA submission. The DKMA has confirmed that Telix has "fully responded to all information requests that have been issued to the company on behalf of the member states", and that it will issue an approval decision notification within 90 days.
Following the DKMA's decision, national stage approvals for the individual 14 member countries are expected to commence within 30-60 days of the notification.
Today's update also follows on from an announcement on Wednesday advising that the company had entered into an exclusive commercial agreement with Nucliber, a Spanish based company, to distribute Illuccix into the Spanish market.
Speaking on the announcement, Telix EMEA President Mr Richard Valeix said:
We thank the DKMA for the collaborative interactions throughout the review process. We are pleased to have confirmation that the so-called "clock-stop" period has concluded, putting us on track for decision in early 2022. PSMA-PET imaging is arguably one of the most important developments in prostate cancer in recent years, we look forward to bringing this next-generation diagnostic tool to patients across Europe, once approved.
Telix Pharmaceuticals share price summary
In the last 12 months, the Telix share price has gained 122% after rallying a further 94% this year to date.
In the past month, it is up 4% whereas it has climbed another 14% in the past week on the back of its most recent updates.
