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Cynata Clears FDA Orphan-Drug Hurdle for CYP-001 Amid Ryoncil® Approval
2:21am on Monday 2nd of June, 2025 AEST
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Biotechnology
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Cynata Clears FDA Orphan-Drug Hurdle for CYP-001 Amid Ryoncil® Approval
2:21am on Monday 2nd of June, 2025 AEST
Key Points
FDA granted orphan-drug exclusivity to Ryoncil® for pediatric steroid-refractory aGvHD
Cynata’s CYP-001 targets newly diagnosed high-risk aGvHD in adults
CYP-001 uses iPSC-derived mesenchymal stem cells, distinct from Ryoncil®’s bone marrow MSCs
Orphan-drug exclusivity does not apply due to different active agents and indications
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