Telix Pharmaceuticals Shares Dive After FDA Raises Supply Chain Concerns

Highlights:

• Telix Pharmaceuticals Limited (ASX: TLX) shares sank 20.7% to $14.60 in early trade after the FDA issued a Complete Response Letter (CRL).
• The CRL flagged deficiencies in manufacturing and supply chain processes for the company’s PET imaging agent, TLX250-CDx.
• Despite the setback, Telix said revenue guidance for 2025 remains unchanged as it excludes unapproved products.

Stock Suffers Sharp Decline

Telix Pharmaceuticals Limited (ASX: TLX) saw its shares tumble after receiving a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA). The letter flagged supply chain and manufacturing issues with the company’s novel imaging agent, TLX250-CDx. At the time of writing, Telix shares had fallen 20.7% to $14.60 by 10:45am AEST, making it one of the biggest losers on the ASX 200. Over the past 12 months, the stock has dropped 22.3%.

FDA’s Concerns Over Manufacturing

The FDA identified shortcomings in the chemistry, manufacturing, and controls package for TLX250-CDx, a PET imaging agent designed to help diagnose and characterise clear cell renal cell carcinoma (ccRCC). If approved, TLX250-CDx would be the first commercially available imaging agent capable of non-invasively detecting this aggressive kidney cancer subtype. The regulator has requested more data on the scaled-up production process for commercial use. In addition, notices of deficiency were issued to two third-party manufacturing and supply partners, which must be resolved before approval can move forward.

Company’s Response and Outlook

Despite the setback, Telix emphasised that the FDA’s concerns are “readily addressable” and confirmed plans to request a meeting with the regulator soon to clarify the resubmission process for its biologics licence application. Importantly, the company highlighted that the CRL does not affect its revenue guidance for 2025, as forecasts exclude income from products not yet approved. While the delay is a blow to investor confidence, Telix remains optimistic that once manufacturing issues are resolved, TLX250-CDx could still become a groundbreaking tool in cancer diagnostics.

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