Tag Archive for: orphan drug designation

U.S. FDA Grants Orphan Drug Designation to Ariceum Therapeutics’ Proprietary Radiopharmaceutical Cancer Therapy

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225Ac-satoreotide is a first-in-class Actinium-labelled somatostatin receptor 2 antagonist targeting extensive-stage Small Cell Lung Cancer or Merkel Cell Carcinoma Orphan Drug Designation follows outstanding preclinical data and FDA IND clearance Phase I/II human trials set to commence in Q1 2025 as a ‘theranostic’ targeted radionuclide treatment Berlin, Germany, 6 February 2025 – Ariceum Therapeutics (Ariceum), a […]

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Heidelberg Pharma granted orphan drug designation by FDA for its proprietary ATAC candidate HDP-101

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Ladenburg, Germany, 27 March 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), is pleased to announce that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for the treatment of multiple myeloma to its lead candidate HDP-101. Heidelberg Pharma is investigating the […]

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US FDA grants Orphan Drug Designation for iOnctura’s first-in-class autotaxin cancer therapy

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Autotaxin inhibitor, IOA-289, recently received the proposed INN cambritaxestat Cambritaxestat is in the Phase I AION-02 trial in combination with chemotherapy in metastatic pancreatic cancer It is the first autotaxin inhibitor to be investigated in cancer patients Amsterdam, The Netherlands and Geneva, Switzerland, 7 March 2024 – iOnctura, a pioneering, clinical-stage biotechnology company developing transformative cancer […]

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Calliditas announces an additional seven year orphan drug exclusivity period for TARPEYO®

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Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that the FDA has granted an orphan drug exclusivity period of seven years for TARPEYO®, expiring in December 2030 based on when the company obtained full approval with a new indication for this drug product. Following full approval in December 2023, TARPEYO® (budesonide) is indicated […]

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4SC receives Orphan Drug Designation (ODD) for resminostat (Kinselby) in CTCL in the European Union

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The European Medicines Agency (EMA) has granted Orphan Drug Designation for resminostat for treatment of cutaneous T-cell lymphoma (CTCL) ODD benefits include 10 years’ market exclusivity in the European Union The Marketing Authorisation Application (MAA) for Kinselby (resminostat) in the EU remains on track for filing in Q1 2024 Planegg-Martinsried, Germany, 18 October 2023 – 4SC […]

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