Minovia Therapeutics Ltd. said that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its investigational therapy, MNV-201, for the treatment of Myelodysplastic Syndrome (MDS), a serious age-related hematopoietic disease. The company said that this designation follows existing FDA Fast Track and Rare Pediatric Disease approvals for MNV-201 in Pearson Syndrome.
The company claims that the Fast Track Designation could accelerate MNV-201’s development and review, allowing for increased FDA interactions, potential priority review, and rolling submissions for a future Biologics License Application.
Minovia is also advancing a business combination with Launch One Acquisition Corp., which the company said is expected to close in late 2025. Post-merger, the combined entity will operate as Minovia Therapeutics and trade on Nasdaq under a new ticker symbol.
MDS is characterized by ineffective hematopoiesis, blood cytopenia, and risk of progression to Acute Myeloid Leukemia. Minovia said it is conducting a Phase Ib study of MNV-201 in low-risk MDS patients, with six of nine expected patients already dosed.
MNV-201 is a cell therapy using Minovia’s proprietary Mitochondrial Augmentation Technology to introduce healthy mitochondria into patients’ stem cells. The company said early-stage studies in Pearson Syndrome have shown a strong safety profile and potential multi-system benefits.
Minovia is based in Haifa, Israel, where it operates a GMP facility for mitochondrial therapy manufacturing, and plans to expand operations to the U.S.
