Minovia Therapeutics Ltd. a clinical-stage biotechnology company developing novel therapies to treat mitochondrial diseases and combat age-related decline, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to the Company’s lead investigational compound, MNV-201 for Myelodysplastic Syndrome (MDS), a serious age-related hematopoietic disease. This designation is in addition to the existing FDA Fast Track and Rare Pediatric Disease Designations for MNV-201 in the treatment of Pearson Syndrome, an ultra-rare and life-threatening mitochondrial disorder affecting children and for which the Company is currently conducting a Phase 2 clinical trial.

“The Fast Track Designation in MDS is further validation of the urgency and potential for our science, which targets the mitochondria, a critical multi-functional organelle. FDA designations such as the FTD help us to decrease the potential time to market and provide additional benefits across the FDA process that, we expect, will prove both medically and financially valuable,” said Minovia Co-founder and CEO, Natalie Yivgi-Ohana, Ph.D.

FDA’s Fast Track Designation is designed to accelerate the development and review of therapies for serious or life-threatening conditions with unmet medical need. The designation provides Minovia with the opportunity for increased FDA interactions, potential eligibility for priority review, and the opportunity for a rolling submission of a future Biologics License Application (BLA) for MNV-201.  

The Company also recently announced entry into a definitive business combination agreement (the “Business Combination Agreement”) with Launch One Acquisition Corp. (Nasdaq: LPAA, “Launch One”), a publicly traded special purpose acquisition company. Following the expected closing of the transaction contemplated by this Business Combination Agreement (the “Business Combination”), projected for late 2025, the combined company will operate as Minovia Therapeutics and trade on Nasdaq under a new ticker symbol.

Source: globenewswire.com