Telix Pharmaceuticals (TLX) Status Update summary

Regulatory update and FDA response

• FDA issued a Complete Response Letter (CRL) for TLX101-CDx (Pixclara), citing concerns over quantitative consistency and requiring additional confirmatory clinical evidence before approval.

• No safety, CMC, or manufacturing issues were raised; the CRL is solely related to clinical data consistency.

• TLX101-CDx retains orphan drug and fast-track status, and is included in international neuro-oncology guidelines.

• The company will seek a hearing with the FDA to clarify remediation requirements and is evaluating strategies to provide the required data, including leveraging ongoing clinical programs.

• Patient access to TLX101-CDx continues via the FDA-approved Expanded Access Program (EAP).

Remediation strategy and next steps

• Preparing for a hearing with the FDA, typically scheduled within 30 days of submission.

• Exploring remediation options, including reanalysis of current data or supplementing with further confirmatory data.

• The EAP for TLX101-CDx will continue, supporting ongoing data collection and patient access.

• Aiming to complete the regulatory review process in 2025, leveraging fast-track and orphan drug designations.

• Will update the market as soon as timelines and remediation scope are clarified.

Context and implications

• The CRL outcome was unexpected given prior FDA consultations and pre-agreed submission scope.

• The company perceives a shift in FDA culture, with less flexibility in data acceptance compared to previous experiences.

• The clinical utility of TLX101-CDx is well established globally, but the FDA requires more robust demonstration of data consistency.

• The EAP remains a valuable source of real-world data and demonstrates ongoing commitment to patient needs.

• No impact on other products such as Zircaix, which followed a different, more traditional regulatory pathway.