Biohaven Announces Several Clinical And Regulatory Milestones

(RTTNews) - Biohaven Ltd. (BHVN), Monday announced several clinical and regulatory milestones across its proprietary Molecular Degrader of Extracellular Proteins platform as well as its glutamate modulation and ion channel programs.

The company's subcutaneous BHV-1300 achieved deep lowering of targeted IgG, with reductions > 60 percent in the lowest subcutaneous dose tested during the ongoing multiple ascending dose study. It has also been safe and well tolerated across the ongoing Phase 1.

The biopharmaceutical company has submitted a new drug application to the U.S. FDA for troriluzole in the treatment of all genotypes of spinocerebellar ataxia, following the completion of the pre-NDA meeting in the fourth quarter of 2024.

Further, Biohaven has initiated dosing in humans for BHV-1400, a novel IgA nephropathy investigational therapy designed to selectively degrade galactose-deficient IgA1 without immunosuppression.

In the fourth quarter, the company has also initiated dosing in humans with BHV-1600, a MoDE engineered to rapidly degrade pathogenic autoantibodies to the b1-adrenergic receptor for the treatment of peripartum cardiomyopathy, a rare type of heart failure.

During the same quarter, Biohaven reported the completion of the enrollment in a pivotal BHV-7000 Phase 2/3 trial in bipolar disorder.

The company has also partnered with Ypsomed to develop and manufacture BHV-1300 in an easy-to-use, autoinjector for self-administration.

Currently, Biohaven's stock is trading at $38.33, down 0.35 percent on the New York Stock Exchange.