The Telix Pharmaceuticals Ltd (ASX: TLX) share price is taking a tumble today.
Shares in the S&P/ASX 200 Index (ASX: XJO) biopharmaceutical company closed yesterday trading for $19.32. In early afternoon trade on Wednesday, shares are changing hands for $18.77, down 2.8%.
For some context, the ASX 200 is 1.2% higher as investors celebrate the lower-than-feared inflation data.
Don't feel too bad for longer-term shareholders though. As you can see on the chart above, the Telix Pharmaceuticals share price remains up a very impressive 86% year to date.
Here's why shares are under some pressure today.
What's happening with the Telix Pharmaceuticals share price?
ASX 200 investors are bidding down Telix Pharmaceuticals shares after the company announced another delay in securing US Food and Drug Administration (FDA) approval for its kidney cancer imaging agent TLX250-CDx, or Zircaix.
Management said that the FDA had not accepted its Biologics License Application (BLA) filing for TLX250-CDx, its investigational imaging agent for clear cell renal cell carcinoma.
According to the release, the FDA identified a filing issue in the Chemistry, Manufacturing and Controls (CMC) package. The specific filing concern was related to "demonstrating adequate sterility assurance during dispensing of TLX250-CDx in the radiopharmacy production environment".
Despite the FDA's concerns, Telix confirmed today that all Process Performance Qualification (PPQ) batches submitted as part of the BLA application passed the sterility requirements of product release.
Management noted that the FDA did not indicate any deficiencies in the clinical or nonclinical data relating to the safety or efficacy of TLX250-CDx, likely mitigating the pressure on the Telix Pharmaceuticals share price today.
The ASX 200 biotech stock expects to be able to complete the required remedial actions within 90 days and resubmit the BLA.
As for any financial impact, Telix said this was a non-material delay with no impact on its revenue forecasts or research and development (R&D) expenditure costs for 2024.
Telix reconfirmed previous revenue guidance of US$490 million to US$510 million for FY 2024.
What did management say?
Commenting on the setback pressuring the Telix Pharmaceuticals share price today, CEO Christian Behrenbruch said, "TLX250-CDx is a breakthrough product and, if approved, would be the first targeted imaging agent for the non-invasive detection of renal cancer."
Behrenbruch added:
We have been working closely with the FDA through the BLA rolling review due to the novel nature of this product candidate and value the FDA's constructive feedback at this early stage in the process.
We expect to be able to satisfy its requirements within a minimal time frame and continue to see a clear path to product commercialisation in 2025.
