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Jun 30, 2023
Biohaven Q2 2023 Earnings Report
Reported financial results for the second quarter and provided a review of recent accomplishments and anticipated upcoming milestones.
Key Takeaways
Biohaven reported a net loss of $90.3 million for the second quarter of 2023. The company highlighted positive interim data from its BHV-7000 EEG biomarker study and the advancement of BHV-8000 into Phase 1 clinical trials. They also plan to submit an IND for BHV-1300 in the second half of 2023.
Announced positive interim data from BHV-7000 EEG biomarker study demonstrating evidence of central nervous system (CNS) target engagement.
Advanced brain penetrant TYK2/JAK1 inhibitor, BHV-8000, into Phase 1 with projected therapeutic concentrations achieved and well-tolerated profile observed to date.
Advanced targeted extracellular protein degradation platform with potential to support numerous clinical candidates across a broad range of high unmet need indications.
Orphan drug designation (ODD) granted by the European Commission for taldefgrobep alfa a novel anti-myostatin adnectin, for the treatment of spinal muscular atrophy (SMA).
Biohaven
Biohaven
Forward Guidance
Biohaven is progressing its product candidates through clinical programs in a number of common and rare disorders. The Company plans to reach significant pipeline milestones in the coming periods.
Positive Outlook
- Announce Phase 1 EEG study results by year-end 2023
- Initiate Phase 2/3 studies with BHV-7000 in the second half of 2023
- Submit IND with BHV-1300, the Company's lead extracellular degrader
- Submit IND with selective Gd-IgA1 degrader
- Initiate Phase 2 study with BHV-8000
Challenges Ahead
- Type A meeting planned with FDA regarding troriluzole program in Spinocerebellar Ataxia Type 3 (SCA3)
- Complete enrollment in Phase 3 obsessive compulsive disorder (OCD) trial expected to complete at end of 2023
- Complete enrollment in Phase 3 clinical study of taldefgrobep alfa in SMA
- Continue advancements across multiple neuroscience and immunoscience indications
- The FDA informed Biohaven it would not review the application given that the study's primary endpoint was not met and thus, would not permit a substantive review