Telix shares tank 20% as FDA flags concerns over novel imaging agent
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The news: Shares in Telix Pharmaceuticals plunged in early trade after biotech received an complete response letter (CRL) from the US Food and Drug Administration (FDA), outlining supply chain concerns over one of its novel imaging agents.
The numbers: Telix shares tumbled 20.7% to $14.60 by 10:45am AEST, leading ASX 200 losses. The stock is now down 22.3% over the last 12 months.
The context: Telix said the CRL identified deficiencies relating to the chemistry, manufacturing and controls package for the company's novel PET imaging agent, known as TLX250-CDx.
If eventually approved, TLX250-CDx will become the first commercially available imaging agent to accurately and non-invasively diagnose and characterise clear cell renal cell carcinoma (ccRCC), the most common and one of the most aggressive sub-types of kidney cancer.
The FDA has requested additional data regarding the scaled-up manufacturing process intended for its commercial use. The US regulator also documented "notices of deficiency" issued to two third-party manufacturing and supply chain partners that will require remediation.
Telix said it believes the FDA's concerns are "readily addressable" and will request a meeting with the regulator "as soon as practicable" to address the deficiencies and determine an appropriate timeframe for the resubmission of its biologics licence application.
The company noted that the CRL does not impact its stated revenue guidance for 2025, as the target excludes revenue from unapproved products.
What they said: "TLX250-CDx breaks new ground as a highly novel biologic-based PET imaging agent using a first-in-class isotope," said Telix managing director and CEO Christian Behrenbruch.
"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 source: ASX
