The Telix Pharmaceuticals Ltd (ASX: TLX) share price is storming higher this morning.
At the time of writing, the clinical-stage biopharmaceutical company's shares are up 5% to $4.24.
Why is the Telix share price rising?
Investors have been buying Telix shares this morning following the release of an update on its prostate cancer imaging product, Illuccix.
According to the release, the Australian Therapeutic Goods Administration (TGA) has accepted the company's submission for the registration of Illuccix and has now commenced the priority evaluation process.
Under the priority registration pathway, the TGA will evaluate Telix's submission to register Illuccix on the Australian Register of Therapeutic Goods (ARTG) with a target timeframe of 150 working days and an indicative decision date of 12 November 2021.
This means that the company now has regulatory reviews for Illuccix in progress in 17 countries globally. This includes Canada, the European Union, and the United States.
Management commentary
Telix's CEO, Dr. Christian Behrenbruch, said: "We are pleased that the TGA has accepted our submission for the registration of Illuccix and has now commenced the priority evaluation phase. This brings us significantly closer to our goal of providing widespread access to state-of-the-art prostate cancer imaging for Australian men living with prostate cancer."
"Should we be successful in gaining TGA registration of Illuccix in Australia, we would also anticipate filing a New Medical Application with Medsafe in New Zealand under the abbreviated evaluation process for medicines approved by recognised overseas regulators. We are committed to providing access to Illuccix for all men living with prostate cancer, regardless of where they reside."
There certainly is a need for this state-of-the-art technology. The release explains that prostate cancer was the most commonly diagnosed cancer in men in both Australia and New Zealand in 2020.
More than 85,000 Australian and New Zealand men were estimated to be living with prostate cancer last year.
