FDA Grants Orphan Drug Designation to Cynata’s Lead Cymerus MSC Product, CYP-001

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.”

Click here to read the full press release.