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This is Baylx’s second IND clearance from FDA in three months. In early June this year, Baylx also received the clearance of an IND from US FDA for the same hUC-MSC product BX-U001, for the treatment of rheumatoid arthritis (RA).
Lead Product(s): Human umbilical cord tissue mesenchymal stem cells
Therapeutic Area: Infections and Infectious Diseases Product Name: BX-U001
Highest Development Status: Phase IProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 11, 2020
Details:
U.S. Food and Drug Administration (FDA) has cleared Baylx's Investigational New Drug (IND) application for BX-U001, a fresh, non-frozen human umbilical cord tissue mesenchymal stem cells (hUC-MSC) product in patients with Rheumatoid Arthritis (RA).
Lead Product(s): BX-U001
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 05, 2020
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