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NEW HAVEN, Conn. - Biohaven Ltd. (NYSE: BHVN), a biotechnology company with a market capitalization of $3.87 billion, announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for troriluzole, a potential treatment for spinocerebellar ataxia (SCA), and granted it Priority Review status. According to InvestingPro data, the company maintains a strong financial position with more cash than debt on its balance sheet, positioning it well for potential commercialization efforts. This expedited review process is reserved for drugs that could represent significant improvements in treatment or provide a therapy where none currently exists.
SCA, a rare and life-threatening neurodegenerative disease, affects roughly 15,000 individuals in the United States. Troriluzole could become the first FDA-approved treatment for SCA, aiming to address a critical unmet medical need. The FDA’s decision on the NDA is anticipated by the third quarter of 2025.
The NDA submission for troriluzole was bolstered by positive results from a real-world evidence study, which demonstrated a 50-70% reduction in the rate of disease progression over a three-year period. This significant finding suggests a delay in disease progression by 1.5 to 2.2 years in patients treated with the drug. With analyst price targets ranging from $56 to $77 per share, Wall Street appears optimistic about the company’s prospects. InvestingPro subscribers can access detailed analysis and 8 additional key insights about Biohaven’s financial health and market position.
Biohaven’s clinical development program for troriluzole has spanned over eight years, including long-term safety data and the first large-scale, multi-center registrational trials in SCA. The company is prepared to commercialize troriluzole in the U.S. upon potential approval in 2025.
Dr. Melissa Beiner, SCA Clinical Development Lead at Biohaven, emphasized the urgency for SCA patients who currently face a relentless decline in motor functions with no available treatments. The Priority Review by the FDA underscores the high unmet need within the SCA community.
Professor Jeremy Schmahmann, M.D., of Harvard Medical (TASE:PMCN) School, hailed the FDA’s acceptance for review as a critical milestone for SCA patients and their families, who have long awaited a therapeutic intervention.
The NDA for troriluzole includes data from two large, multi-center registrational trials, along with an external control arm provided by independent natural history cohorts in the United States and Europe. Biohaven’s study design was guided by FDA instructions, ensuring rigorous matching of treated subjects to untreated controls.
Biohaven has previously received Fast-Track and Orphan Drug Designation for troriluzole from the FDA, highlighting the therapy’s potential significance in treating SCA. An expanded access protocol is currently enrolling eligible SCA patients, offering early access to the investigational drug before FDA approval.
This news article is based on a press release statement. Investors should note that Biohaven’s stock has shown significant volatility, with a beta of 3.91, and currently trades at $38.25, between its 52-week range of $26.80 to $62.21. For comprehensive analysis and detailed financial metrics, including Fair Value estimates and growth projections, check out the full research report available on InvestingPro.
In other recent news, Biohaven Pharmaceutical (TADAWUL:2070) Holding has been the subject of several analyst reports. Deutsche Bank (ETR:DBKGn) initiated coverage on Biohaven shares with a Buy rating and a $65 price target, highlighting the potential for steady value creation under the leadership of CEO Vlad Coric. The firm also emphasized the significant growth opportunity presented by Biohaven’s mid to late-stage clinical assets.
Similarly, H.C. Wainwright maintained a Buy rating on Biohaven shares, commenting on the progress in the company’s research and development efforts. The firm noted the promising results of Biohaven’s novel IgG degrader, BHV-1300, in its Multiple Ascending Dose study. Meanwhile, Bernstein reiterated its Outperform rating on Biohaven shares, expressing strong conviction in the therapeutic potential of the company’s degrader platform.
RBC Capital Markets adjusted its price target for Biohaven, increasing it to $61 from $58, while maintaining an Outperform rating. The firm anticipates that investor focus will be on upcoming 2025 catalysts, particularly the resubmission of troriluzole to the U.S. Food and Drug Administration. These recent developments underscore the positive outlook for Biohaven’s ongoing research and potential market opportunities.
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