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Minovia Granted Orphan Drug Designation for MNV-201 in Myelodysplastic Syndromes (MDS)
Minovia Therapeutics announces that the U.S. Food and Drug Administration has granted Orphan Drug Designation to the Company's lead investigational compound, MNV-201 for Myelodysplastic Syndrome, a serious age-related hematopoietic disease. This designation is in addition to the existing FDA Fast Track Designation in MDS, as well as both Fast Track and Rare Pediatric Disease Designations for MNV-201 in the treatment of Pearson Syndrome. The Company announced entry into a definitive business combination agreement with Launch One Acquisition Corp. Following the expected closing of the transaction contemplated by this Business Combination Agreement, projected for late 2025, the combined company will operate as Minovia Therapeutics and trade on Nasdaq under a new ticker symbol.
Minovia Granted Fast Track Designation for MNV-201 in MDS
Minovia Therapeutics announces that the U.S. Food and Drug Administration has granted Fast Track Designation to the company's lead investigational compound, MNV-201 for Myelodysplastic Syndrome, 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 Company also recently announced entry into a definitive business combination agreement with Launch One Acquisition Corp. Following the expected closing of the transaction contemplated by this Business Combination Agreement, projected for late 2025, the combined company will operate as Minovia Therapeutics and trade on Nasdaq under a new ticker symbol.
Minovia Receives $350,000 Grant from Countdown for a Cure Foundation
Minovia Therapeutics has been chosen to receive a $350,000 grant from Countdown for a Cure for a research proposal related to the development of novel mitochondrial blood-based biomarkers. In addition to the novel MAT-based mitochondrial therapies under development, Minovia has set dual goals of developing biomarkers to quantify mitochondrial content, quality and function and of using these biomarkers to determine mitochondrial scores in healthy individuals relative to mitochondrial disease patients. For this reason, Minovia opened a clinical trial in Sheba Medical Center to collect blood samples from both healthy volunteers and patients suffering from mitochondrial diseases. The Countdown for a Cure grant will fund clinical operations for blood sample collection from approximately 30 patients with primary mitochondrial diseases, and 140 samples from healthy controls. The samples collected will be analyzed in Minovia's labs with its newly developed biomarkers, and a "MitoScore" will be determined for each sample. In addition, the Countdown for a Cure funding will support the development of new biomarkers using novel research tools. The Company also recently announced entry into a definitive business combination agreement with Launch One Acquisition. Following the expected closing of the transaction contemplated by this Business Combination Agreement, projected for late 2025, the combined company will operate as Minovia Therapeutics and trade on Nasdaq under a new ticker symbol.
Minovia announces interim data from Phase 2 trial in Pearson Syndrome
Minovia Therapeutics announces interim results of the ongoing Phase 2 trial of the Company's lead investigational compound MNV-201 in Pearson Syndrome, a fatal pediatric mitochondrial disease characterized by sideroblastic anemia, failure to thrive and exocrine pancreas dysfunction. The interim analysis was presented at the United Mitochondrial Disease Foundation Annual Meeting on June 20, 2025. The analysis showed that MNV-201 has a positive safety profile even in this fragile patient population, currently meeting the Phase 2 trial's primary safety endpoint. In the presentation, Minovia's CSO Noa Sher reported no treatment related severe adverse events and no anti-mitochondrial antibodies were detected. In addition, all adverse events were transient in nature and the majority resolved within four days. Most adverse events were associated with the apheresis procedure necessary to procure patient-derived cells and conducted prior to the drug's administration. In addition to safety data, Minovia is collecting preliminary efficacy data based on a novel endpoint identified through a natural history study performed at the Children's Hospital of Philadelphia and supported by Minovia funding. Results indicate that at the six-month follow-up, two of the first three patients experienced improved growth parameters relative to those prior to treatment, as measured by height standard deviation score. Quality of life scores also showed improvement for two of the first three patients. The Company continues to enroll patients in the trial, which is expected to conclude before the end of 2025.In addition to the three patients in the trial, the Company gathered data from two compassionate use patients affected by Kearns-Sayre syndrome, another mitochondrial deletion syndrome. In addition to a favorable safety profile, early data indicates improved quality of life scores for both patients. The FDA has granted both Fast Track and Rare Pediatric Disease Designation to MNV-201, which is in Phase 2 clinical trials for the treatment of Pearson Syndrome, an ultra-rare and life-threatening mitochondrial disorder affecting children. The Company is advancing interactions with the FDA to align on a pivotal trial design and expects to initiate registrational studies in 2026.
Minovia announces FDA Fast Track, RPD designations to MNV-201
Minovia Therapeutics announces that the U.S. Food and Drug Administration, FDA, has granted Fast Track Designation to the Company's lead investigational compound, MNV-201. The FDA has also granted Rare Pediatric Disease, RPD, Designation to MNV-201, which is in Phase 2 clinical trials for the treatment of Pearson Syndrome, an ultra-rare and life-threatening mitochondrial disorder affecting children.
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