On Monday, Biohaven Ltd. (NYSE:BHVN) highlighted data from BHV-1300, showing rapid and deep reductions in total IgG for the potential treatment of autoimmune disease.

In the four-week Phase 1 study, subcutaneously administered BHV-1300 at a dose of 1000 mg weekly achieved rapid, deep, and sustained reductions in total IgG of up to 84%, with a median reduction of 80%.

IgG stands for Immunoglobulin G, an antibody that helps prevent infections. But in autoimmune disorder, body’s immune system attacks its own healthy cells due to higher IgG levels.

Also Read: Biohaven Advances in Immunotherapy: Significant IgG Reduction Achieved with BHV-1300, Gains Analyst Approval

Reductions occurred within hours of each dose, were progressive, and were sustained compared to baseline over the four weeks.

BHV-1300 was safe and well-tolerated in subcutaneous doses up to 2000 mg with no clinically significant increases in ALT, AST, or bilirubin, no clinically significant reductions in albumin, and no clinically significant increases in cholesterol over the four-week dosing period compared to placebo.

There were no clinically significant reductions in IgG3, IgA, IgE, or IgM compared to baseline. Most adverse events (AEs) were mild and self-resolving. There were no discontinuations due to AEs related to the study drug, and there were no serious or severe AEs.

The Phase 1 study is ongoing, and multiple doses will be escalated to explore the full range of targeted IgG lowering possible with this technology to customize an ideal treatment approach for different disease indications.

In February, the FDA accepted for review the company’s New Drug Application (NDA) for troriluzole for adult patients with spinocerebellar ataxia (SCA) and has granted Priority Review.

The FDA’s decision regarding the NDA is expected within 6 months of filing (during 3Q of 2025).

Price Action: BHVN stock is down 8.90% at $33.87 at the last check Monday.

Read Next:

• Microchip Technology To Cut Workforce By 2,000 Employees: Details