HAIFA, Israel — September 18, 2025 — Leads & Copy —Minovia Therapeutics Ltd. has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for its lead investigational compound, MNV-201, targeting Myelodysplastic Syndrome (MDS). The FDA previously granted Fast Track and Rare Pediatric Disease Designations for MNV-201 in treating Pearson Syndrome, for which the company is conducting a Phase 2 clinical trial.
According to Minovia Co-founder and CEO, Natalie Yivgi-Ohana, Ph.D., the designation validates the potential of their science targeting mitochondria. The FDA’s Fast Track Designation is designed to accelerate the development and review of therapies for serious or life-threatening conditions with unmet medical needs.
Minovia recently announced a definitive business combination agreement with Launch One Acquisition Corp. (Nasdaq: LPAA), expected to close in late 2025, with the combined company operating as Minovia Therapeutics and trading on Nasdaq under a new ticker symbol.
MDS is characterized by ineffective hematopoiesis, leading to blood cytopenia and a risk of Acute Myeloid Leukemia (AML). Minovia is conducting a Phase Ib study of MNV-201 in low-risk MDS patients, demonstrating that MDS is an age-related mitochondrial disease.
MNV-201 is a cell therapy using Minovia’s Mitochondrial Augmentation Technology (MAT) to add healthy mitochondria into a patient’s stem cells, aiming to restore organ function. Early-stage clinical studies have shown a strong safety profile and signs of multi-system benefit in Pearson Syndrome patients.
Minovia Therapeutics is focused on treatments to replace defective mitochondria with healthy ones, targeting mitochondrial diseases and aging. The company is based in Haifa, Israel, and operates a GMP facility for mitochondrial drug substance manufacturing for clinical trials.
Contact:
Natalie Yivgi Ohana, Co-Founder and CEO
+972-74-7039954
info@minoviatx.com
Source: Minovia Therapeutics
