Telix Pharmaceuticals Ltd (ASX: TLX) shares are getting pounded today.
Shares in the S&P/ASX 200 Index (ASX: XJO) diagnostic and therapeutic product developer closed yesterday trading for $18.40. In earlier trade, shares crashed to $13.94 each, down 24.2%. After some likely bargain hunting, shares are changing hands for $14.95 apiece at the time of writing, down 18.8%.
Here's what's got investors flocking for the exit today.
Telix shares tumble on FDA response
Telix shares are taking a tumble after the company announced that it had received a Complete Response Letter (CRL) from the United States Food and Drug Administration (FDA).
The FDA letter addresses Telix's Biologics License Application (BLA) for its TLX250-CDx (Zircaix) product. Zircaix is an investigational positron emission tomography (PET) agent intended to diagnose and characterise renal masses as clear cell renal cell carcinoma (ccRCC).
As you can likely guess by the plunging Telix share price today, the company revealed that the FDA's response identified deficiencies relating to the Chemistry, Manufacturing, and Controls (CMC) package.
The FDA now want more data to establish comparability between the drug product used in the ZIRCON Phase 3 clinical trial and the scaled-up manufacturing process intended for commercial use.
The FDA also documented notices of deficiency issued to two third-party manufacturing and supply chain partners. Telix indicated that these will require remediation prior to resubmission of its BLA.
The ASX 200 healthcare stock said it believes the FDA's concerns are "readily addressable", stating that submission remediation will begin immediately. The company said it will request a "Type A" meeting with the FDA as soon as possible.
What did management say?
Commenting on the setback that's hammering Telix shares today, CEO Christian Behrenbruch said, "TLX250-CDx breaks new ground as a highly novel biologic-based PET imaging agent using a first-in-class isotope."
Behrenbruch added:
Like many radiopharmaceuticals, it has a complex supply chain, and as the field advances this creates new challenges around the regulatory framework applied to these products. We believe the outstanding matters are resolvable and that we can address the remaining FDA requests within a reasonable time frame.
The company said that the FDA's response letter won't impact its FY 2025 revenue guidance, which excludes revenue forecasts from unapproved products.
Telix said it intends to continue to provide patient access to TLX250-CDx through the FDA-approved expanded access program, subject to consultation with the FDA.
With today's big fall factored in, Telix shares are down 37% in 2025. Longer term, shares remain up 831% over five years.
