Heidelberg Pharma AG, a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), today announced that its licensing partner Telix Pharmaceuticals Limited, headquartered in Melbourne, Australia, (ASX: TLX, NASDAQ: TLX; Telix) was informed by the US Food and Drug Administration (FDA) that deficiencies relating to the Chemistry, Manufacturing, and Controls (CMC) package have been identified.
– FDA has requested additional data relating to the Chemistry, Manufacturing, and Controls (CMC) package
– Expected payment of USD 70 million from HealthCare Royalty to Heidelberg Pharma will be delayed
– Current cash reach until Q1 2026