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Minovia Therapeutics (NASDAQ:LPAA) has reported positive interim results from its Phase 2 trial of MNV-201 for Pearson Syndrome, a fatal pediatric mitochondrial disease. The trial demonstrated no treatment-related serious adverse events and showed preliminary efficacy signals in growth parameters.
Key findings include improved growth parameters in two out of three initial patients at six-month follow-up, and enhanced quality of life scores. The company also reported favorable safety data from two compassionate use patients with Kearns-Sayre syndrome.
MNV-201 has received both Fast Track and Rare Pediatric Disease Designation from the FDA. Minovia plans to initiate registrational studies in 2026 and is merging with Launch One Acquisition Corp., with the combined entity expected to trade on Nasdaq by late 2025.
Minovia Therapeutics (NASDAQ:LPAA) has received two significant FDA designations for its lead compound MNV-201: Fast Track Designation and Rare Pediatric Disease Designation. The therapy is currently in Phase 2 clinical trials for treating Pearson Syndrome, an ultra-rare and life-threatening mitochondrial disorder affecting children.
The Fast Track Designation enables accelerated development and review processes, increased FDA interactions, potential priority review eligibility, and rolling BLA submission opportunities. The Rare Pediatric Disease Designation could qualify Minovia for a pediatric priority review voucher (PRV) upon initial approval, historically valued at over $100 million.
The company plans to initiate registrational studies in 2026 and has entered a business combination agreement with Launch One Acquisition Corp. Following the expected closing in late 2025, Minovia will trade on Nasdaq under a new ticker symbol.
Minovia Therapeutics and Launch One Acquisition Corp. (NASDAQ:LPAA) have announced a definitive business combination agreement to create a Nasdaq-listed mitochondrial therapy company. The combined entity, to be named Mito US One Ltd., will focus on commercializing Mitochondrial Augmentation Technology (MAT) platform.
The transaction assigns Minovia a $180 million pre-money valuation, with potential additional shares worth $57.5 million as earnout. Launch One's trust holds $239.7 million, and the parties anticipate at least $18 million in PIPE investments. The deal is expected to close in Q4 2025.
Minovia's lead product, MNV-201, has FDA Fast Track and Rare Pediatric Disease designations. The company has treated 23 patients across various conditions, showing promising results in increasing body weight, mobility, and kidney function, with no drug-related adverse effects.
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