FDA Requests Additional Data from Telix Pharmaceuticals, Delaying Payment to Heidelberg Pharma

Heidelberg Pharma AG's partner, Telix Pharmaceuticals, encountered a regulatory setback concerning its imaging agent, TLX250-CDx. The FDA has raised concerns over the Chemistry, Manufacturing, and Controls (CMC) package, necessitating further data. This has resulted in a delay in a planned USD 70 million payment from HealthCare Royalty to Heidelberg Pharma.

Telix had submitted a Biologic License Application (BLA) for TLX250-CDx, which received a Priority Review. Despite initial acceptance, a Complete Response Letter was issued due to identified deficiencies. Telix is tasked with proving comparability between the drug used in the ZIRCON Phase 3 trial and the intended commercial product. Two third-party partners also need to address deficiencies.

This development affects Heidelberg Pharma's financial timeline, with cash reserves expected to last until the first quarter of 2026.