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FDA Grants Orphan Drug Designation to Cynata’s Lead Cymerus MSC Product, CYP-001
Mar. 28, 2018 09:00AM PST
Genetics InvestingAustralian stem cell and regenerative medicine company Cynata Therapeutics Limited (ASX:CYP) is pleased to announce that the United States Food and Drug Administration (FDA) has granted Cynata Orphan Drug Designation for CYP-001 for the treatment of acute graft versus host disease (GvHD). CYP-001 is the lead mesenchymal stem cell (MSC) product manufactured using Cynata’s proprietary …
Australian stem cell and regenerative medicine company Cynata Therapeutics Limited (ASX:CYP) is pleased to announce that the United States Food and Drug Administration (FDA) has granted Cynata Orphan Drug Designation for CYP-001 for the treatment of acute graft versus host disease (GvHD). CYP-001 is the lead mesenchymal stem cell (MSC) product manufactured using Cynata’s proprietary Cymerus platform manufacturing technology.
As quoted in the press release:
Dr Kilian Kelly, Cynata’s Vice President, Product Development, said, “We are delighted that the FDA has seen fit to grant Orphan Drug Designation to CYP-001, in recognition of the potential of this product to address the substantial unmet need associated with GvHD. This follows on from our successful pre-IND meeting with the FDA last year, and we look forward to building our productive relationship with the FDA over the coming years.”