FDA fordert zusätzliche Daten zum CMC-Paket (Chemistry, Manufacturing and Controls) an
Erwartete Zahlung von 70 Mio. USD von HealthCare Royalty an Heidelberg Pharma wird sich verzögern
Aktuelle Liquiditätsreichweite bis zum ersten Quartal 2026
Die Heidelberg Pharma AG (FWB: HPHA), ein Biotech-Unternehmen in der klinischen Phase, das innovative Antikörper-Wirkstoff-Konjugate (ADC) entwickelt, gibt bekannt, dass ihr Lizenzpartner Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX; Telix) mit Sitz in Melbourne, Australien, von der US-amerikanischen Food and Drug Administration (FDA) darüber informiert wurde, dass Mängel in Bezug auf das CMC-Paket (Chemistry, Manufacturing and Controls) festgestellt wurden.
Ende Dezember 2024 hatte Telix einen Antrag auf Zulassung (Biologic
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