NEW HAVEN, Conn. - Biohaven Ltd. (NYSE: BHVN) has announced positive results from a pivotal study of troriluzole in treating spinocerebellar ataxia (SCA), a rare neurodegenerative disorder. The study met its primary endpoint, demonstrating a significant slowing of disease progression over a three-year period.
The oral medication, taken once daily, showed a 50-70% reduction in the rate of decline compared to untreated patients, equating to a 1.5-2.2 years delay in disease progression. These findings were consistent across nine prespecified primary and secondary endpoints.
SCA, which affects around 15,000 people in the United States and 24,000 in Europe and the UK, currently has no FDA-approved treatments. Troriluzole's efficacy was measured by the modified functional Scale for the Assessment and Rating of Ataxia (f-SARA), with statistically significant improvements noted after one and two years of treatment.
Dr. Susan Perlman of UCLA highlighted the significance of these findings, noting the potential for troriluzole to provide patients with additional years of independence. Jeremy Schmahmann, M.D., from Harvard Medical School, also emphasized the drug's potential to change the course of the disease.
The study, BHV4157-206-RWE, was conducted in collaboration with the FDA and used real-world evidence to compare troriluzole-treated patients with matched untreated subjects. The robustness of the findings was further supported by additional analyses using independent natural history controls from European studies.
Biohaven plans to submit a New Drug Application to the FDA in the fourth quarter of 2024, with the company anticipating potential commercialization in the US in 2025, subject to regulatory approval. Troriluzole has already received Fast-Track and Orphan drug designations from the FDA, which may expedite the review process.
The company will hold a conference call and webcast today to discuss these results. The information in this article is based on a press release statement from Biohaven Ltd.
In other recent news, Biohaven Pharmaceutical Holding has been the focus of multiple analyst firms. Jefferies initiated coverage on Biohaven with a Buy rating, noting the company's diverse portfolio, which includes promising programs such as BHV-1300 and BHV-7000. This sentiment was echoed by Bernstein SocGen Group, which initiated coverage with an Outperform rating, highlighting the potential of the company's IgG degrader program.
Biohaven has also seen significant operational developments. The company filed a prospectus supplement for the resale of approximately 1.8 million common shares by a significant shareholder, a part of the ongoing financial arrangements. Furthermore, Biohaven received FDA approval for Multiple Ascending Dose studies in Rheumatoid Arthritis patients for its lead candidate BHV-1300.
Morgan Stanley initiated coverage on Biohaven, giving the stock an Overweight rating, while TD Cowen maintained a Buy rating on the company. Both firms cited the potential of Biohaven's diverse pipeline and the promising results from the company's drug candidate, known as '1300. These are recent developments that underscore Biohaven's commitment to advancing its drug development programs across multiple therapeutic areas.
InvestingPro Insights
As Biohaven Ltd. (NYSE: BHVN) makes strides with its promising treatment for spinocerebellar ataxia, investors and industry watchers are closely monitoring the company's financial health and market performance. Biohaven's recent achievements in clinical trials may have a significant impact on its future profitability and market valuation.
One key aspect to consider is the company's financial position. According to InvestingPro data, Biohaven holds a market capitalization of $3.82 billion. This valuation reflects investor confidence in the company's growth prospects, which may be bolstered by the positive study results of troriluzole. Moreover, Biohaven's cash position appears strong, as indicated by one of the InvestingPro Tips which notes that the company holds more cash than debt on its balance sheet. This is a crucial factor for investors, as it suggests the company has a solid financial foundation to support its ongoing research and potential market expansion.
Despite the optimism surrounding the clinical trial outcomes, it's important to note that Biohaven is not currently profitable, as highlighted by another InvestingPro Tip. Analysts do not expect the company to be profitable this year, and net income is projected to decline. Additionally, the company's Price/Book ratio, as of the last twelve months leading up to Q2 2024, stands at a high 9.95, which could signal that the stock is trading at a premium relative to its book value.
Investors considering Biohaven's stock should be aware of these financial metrics and the company's strategic moves. For those seeking more in-depth analysis, there are 12 additional InvestingPro Tips available on https://www.investing.com/pro/BHVN, providing a comprehensive view of Biohaven's financial health and market potential.
With the New Drug Application submission on the horizon and the potential for FDA approval, Biohaven's financial metrics and market performance will continue to be of interest to stakeholders. The company's progress, coupled with its strategic financial management, will be key factors in its journey towards commercializing troriluzole and potentially delivering value to both patients and investors.
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