Biohaven holds strong target amid FDA review

EditorTanya Mishra
Published 09/23/2024, 12:46 PM
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BTIG maintained its Buy rating and $59.00 price target for Biohaven Pharmaceutical Holding (NYSE:BHVN). The firm's stance comes as Biohaven's Phase 3 program for Troriluzole in Spinocerebellar Ataxia (SCA) continues to face scrutiny over its control group's unexpected lack of decline during the trial period.

Despite this, the treatment arm's comparison to historical control arms over three years has shown consistency with expected progression patterns for different types of SCA, suggesting a possible treatment effect.

Biohaven's recent data release presented a compelling case, with an additional group of around 30 treated patients showing minimal decline after three years. This supports the notion that the non-decline observed in the original treatment group could indeed be due to Troriluzole's efficacy.

Moreover, data from a previous study indicated that treated patients' condition worsened during a treatment gap, further implying a positive effect of the drug.

The FDA is expected to thoroughly examine the treatment group to ensure that the lack of decline is a result of the treatment and not an anomaly. Biohaven's ongoing dialogue with the FDA includes reanalysis of data, which has involved adjustments in patient matching across different control groups. The company's efforts to align its data with regulatory expectations are part of its comprehensive strategy to secure approval.

In addition to Troriluzole, BTIG highlights BHV-7000 as a key reason to invest in Biohaven. The firm recently hosted a Key Opinion Leader (KOL) event focusing on schizophrenia and bipolar disorder, underscoring the potential of a safe antiseizure medication (ASM) in treating bipolar disorder, which adds to Biohaven's prospects.

In other recent news, Biohaven Pharmaceutical Holding has reported successful results from its clinical trials of troriluzole for treating Spinocerebellar Ataxia (SCA). The trials showed statistically significant improvements over natural history controls and are expected to lead to a New Drug Application (NDA) filing in the next quarter. Piper Sandler maintained an Overweight rating on Biohaven shares, indicating confidence in the drug's commercial prospects.

Jefferies and Bernstein SocGen Group have initiated coverage on Biohaven with a Buy and Outperform rating respectively, emphasizing the potential of the company's diverse portfolio. Biohaven also plans to submit a New Drug Application for troriluzole in the fourth quarter of 2024, with potential commercialization in 2025. The company has filed a prospectus supplement for the resale of approximately 1.8 million common shares by a significant shareholder.

InvestingPro Insights


As Biohaven Pharmaceutical Holding (NYSE:BHVN) navigates the FDA approval process for its Troriluzole treatment, investors are closely monitoring the company's financial health and market performance. According to InvestingPro data, Biohaven holds a market capitalization of $3.82 billion, with a high Price / Book multiple of 9.95, reflecting a premium valuation by the market. Despite a challenging period with an operating loss of $781.27 million over the last twelve months, Biohaven's stock has provided a significant 1-year price total return of 138.57%, showcasing investor optimism.

InvestingPro Tips reveal that Biohaven holds more cash than debt on its balance sheet, which is a positive sign of financial stability. Additionally, two analysts have revised their earnings estimates upwards for the upcoming period, indicating potential confidence in the company's future performance. With these insights, investors can better gauge the investment potential of Biohaven. For those seeking more in-depth analysis, InvestingPro offers additional tips on the company at https://www.investing.com/pro/BHVN.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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