BioRestorative Therapies, Inc. (BRTX) announced that the FDA has granted Fast Track designation to its lead candidate, BRTX-100, for the treatment of chronic lumbar disc disease or cLDD.
BRTX-100, a stem cell-based therapy, aims to offer a novel solution for patients suffering from cLDD, a condition typically treated with conservative non-surgical approaches or surgery.
The Fast Track designation recognizes the drug's potential to meet significant unmet medical needs in the treatment of cLDD, particularly for those who have not responded to existing treatments.
The company's positive preliminary Phase 2 clinical data supports BRTX-100's potential, showing promising results in reducing pain and improving functionality in patients with cLDD.
This designation facilitates more frequent interactions with the FDA, potentially leading to accelerated development and approval, including Priority Review for a Biologics License Application or BLA.
BioRestorative aims to move BRTX-100 forward, addressing the unmet needs of millions of patients suffering from chronic back pain and degenerative disc disorders.
Currently, BRTX is trading at $1.97 up by 2.95%.
For comments and feedback: editorial@rttnews.com