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NEW HAVEN, Conn. - Biohaven Ltd. (NYSE: BHVN), a $3.76 billion market cap biopharmaceutical company currently trading at $37.18, reported significant progress in its ongoing Phase 1 study of BHV-1300, a potential first-in-class extracellular IgG degrader. According to InvestingPro data, the company maintains a strong financial position with more cash than debt on its balance sheet. The study demonstrated up to 84% reduction in total immunoglobulin G (IgG) levels with a median reduction of 80% after weekly subcutaneous doses of 1000 mg.
The reductions in IgG, a class of antibodies, were rapid, deep, and sustained over the four-week period, with effects seen within hours after each dose. This positions BHV-1300 as a potential new treatment for autoimmune diseases, including Graves’ disease, which affects millions globally. With a healthy current ratio of 2.89, InvestingPro analysis shows Biohaven has ample liquidity to support its ongoing research initiatives.
BHV-1300, developed with Biohaven’s MoDE™ technology, is designed to selectively target and degrade IgG1, IgG2, and IgG4, while sparing IgG3, thus preserving essential immune defense mechanisms. The drug was well-tolerated in doses up to 2000 mg, with most adverse events being mild and self-resolving. There were no serious adverse events, discontinuations due to adverse events, or clinically significant changes in liver enzymes, albumin, cholesterol, or other immunoglobulins, including IgG3.
Dr. Tova Gardin, Chief Translational Officer at Biohaven, highlighted the efficacy of BHV-1300 in lowering total IgG and its potential to revolutionize the treatment of autoimmune diseases. The company plans to initiate a Phase 2 study for Graves’ disease in mid-2025 and explore its use in other autoimmune conditions.
Graves’ disease, caused by IgG1 autoantibodies that stimulate the thyroid, is currently managed with surgery, ablation, or anti-thyroid drugs. BHV-1300’s selective degradation of these autoantibodies could offer a more targeted treatment approach.
The ongoing Phase 1 study aims to further characterize the range of IgG lowering achievable with BHV-1300. The drug’s development benefits from a collaboration with Yale University, where the MoDE technology was initially discovered, and an ongoing partnership with Ypsomed AG for the development of an autoinjector for self-administration.
Biohaven is a biopharmaceutical company focused on developing treatments for a variety of diseases. The company’s innovative portfolio is supported by its drug development expertise and multiple proprietary platforms. This news is based on a press release statement.
In other recent news, Biohaven Ltd. has received FDA Priority Review for its New Drug Application (NDA) for troriluzole, a potential treatment for spinocerebellar ataxia (SCA). This expedited review is reserved for drugs that could significantly improve treatment options or provide a therapy where none currently exists, with a decision expected by the third quarter of 2025. The NDA submission was supported by positive results from a real-world evidence study, showing a 50-70% reduction in disease progression over three years. Biohaven has also received Fast-Track and Orphan Drug Designations for troriluzole from the FDA, highlighting the drug’s potential significance.
Deutsche Bank (ETR:DBKGn) has initiated coverage on Biohaven with a Buy rating and a price target of $65, citing the leadership of CEO Vlad Coric and the company’s potential for steady value creation. H.C. Wainwright also maintained a Buy rating with a $59 price target, noting significant progress in Biohaven’s research and development efforts, particularly with its novel IgG degrader, BHV-1300. The study results for BHV-1300 indicated a reduction of more than 60% in targeted IgG, with a favorable safety profile compared to some competitors.
Furthermore, the European Medicines Agency is currently reviewing a Marketing Authorization Application for troriluzole, and an expanded access protocol is enrolling eligible SCA patients. These developments reflect Biohaven’s strategic direction and the confidence of investors and analysts in its clinical programs and market opportunities.
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