The Telix Pharmaceuticals Ltd (ASX: TLX) share price has bounced back into the green today.
Shares in the S&P/ASX 200 Index (ASX: XJO) biopharmaceutical company closed up 15.3% on Friday trading for $18.15 apiece. At the time of writing, in morning trade on Monday, shares are changing hands for $18.21 apiece, up 0.3%.
For some context, the ASX 200 is up 0.9% at this same time.
Friday's big share price leap came after Telix Pharmaceuticals announced positive results from its ProstACT SELECT clinical cancer trial.
Today the company reported on progress on approval for its kidney cancer imaging agent with the United States Food and Drug Administration (FDA).
Here's what investors are considering on Monday.
Telix Pharmaceuticals share price wobbles
Investors are bidding up the Telix Pharmaceuticals share price after the company said it has completed the submission of a Biologics License Application (BLA) to the FDA.
The BLA involves Telix's investigational radiodiagnostic PET agent, TLX250-CDx for the characterisation of renal masses as clear cell renal cell carcinoma (ccRCC). The clear cell variant of renal cancer is the most common and aggressive sub-type of kidney cancer.
The BLA submission was based on Telix's successful global Phase III ZIRCON study in ccRCC.
According to the ASX 200 biotech company, its ZIRCON study met all co-primary and secondary endpoints, demonstrating a sensitivity of 86%, specificity of 87% and a positive predictive value of 93% for ccRCC. That includes patients with small, difficult to detect lesions.
Commenting on the submission helping lift the Telix Pharmaceuticals share price today, chief development officer James Stonecypher said:
Completing the BLA submission for TLX250-CDx represents a significant milestone for Telix as we bring our breakthrough investigational kidney cancer imaging agent closer to market as a non-invasive diagnostic for patients.
We believe TLX250-CDx is a natural follow-on product to Illuccix as it is targeted at the same clinical stakeholders, the urologist and urologic oncologist, and leverages the proven commercial and distribution infrastructure developed through the launch of Illuccix.
The company has also requested a priority review from the FDA as part of its BLA submission process under the eligibility criteria of the Breakthrough Therapy designation.
Management noted that if the FDA grants priority review status, it would potentially support an expedited review time and could further build on the biotech company's successful urology imaging franchise.
If approved, TLX250-CDx will be the first commercially available targeted radiopharmaceutical imaging agent specifically for kidney cancer in the US.
With today's intraday gains factored in, the Telix Pharmaceuticals share price is now up 80% in 2024.
