Biohaven .(US:BHVN) Prnewswire·2025-08-11 11:00Core Insights - Biohaven Ltd. reported its financial results for Q2 2025, highlighting significant progress in clinical development and upcoming regulatory decisions, particularly regarding VYGLXIA® for spinocerebellar ataxia (SCA) [1][2][3] Financial Performance - Cash, cash equivalents, marketable securities, and restricted cash totaled approximately $408.2 million as of June 30, 2025 [4][10] - R&D expenses were $184.4 million for Q2 2025, a decrease from $314.8 million in Q2 2024, primarily due to a one-time non-cash expense in the previous year [11] - General and administrative expenses increased to $27.3 million in Q2 2025 from $19.0 million in Q2 2024, attributed to higher non-cash share-based compensation and legal costs [12] - The net loss for Q2 2025 was $198.1 million, or $1.94 per share, compared to a net loss of $319.8 million, or $3.64 per share, in Q2 2024 [14][20] Clinical Development Highlights - The VYGLXIA NDA for SCA has a PDUFA date set for Q4 2025, with clinical trial inspections completed without observations [4][7] - BHV-1300, a MoDE degrader, showed IgG reductions of up to 87% in Phase 1 trials, indicating potential for treating IgG-mediated diseases [4][5] - BHV-1400, a TRAP degrader, achieved sustained reductions in Gd-IgA1 of over 80%, highlighting its potential for IgA Nephropathy treatment [4][5] - BHV-1510 demonstrated tumor reduction in all six patients treated in a Phase 1/2 study, indicating promising early clinical activity [4][9] - A pivotal Phase 2/3 study for BHV-8000 in Parkinson's disease has been initiated, targeting critical inflammatory pathways [4][7] Upcoming Milestones - Biohaven is preparing for the potential commercial launch of VYGLXIA if approved, with continued excellence in study execution and patient enrollment expected [2][7] - The company anticipates initiating a Phase 2 study in obesity in the second half of 2025 and a pivotal major depressive disorder topline result in the same timeframe [7][8]