Biohaven Ltd (NYSE:BHVN) soared up to 25.02 percent on Thursday, closing at $14.69 apiece, as investors gobbled up shares after its drug candidate for spinocerebellar ataxia (SCA) moved closer to commercialization.
This followed a regulatory filing on the same day the Food and Drug Administration (FDA) officially accepted for review the listed firm’s resubmitted new drug application for Vyglxia, almost a year after the agency flagged concerns about potential bias, design flaws, and unmeasured confounding factors.
“The FDA communicated that it considers the resubmission a complete response to the November 4, 2025 action letter, and has assigned a user fee goal date in the first quarter of 2027. The FDA plans to convene a meeting of the Peripheral and Central Nervous System Advisory Committee to obtain input from external stakeholders,” Biohaven Ltd said.
Details about the advisory meeting have yet to be identified.
Photo by Mizuno K on pexels
Baird hikes price target
Investment firm Baird reiterated its bullish rating for the stock following the filing, saying that the FDA approval came as a positive surprise.
From $42 previously, its stock price is now set at $48, alongside an outperform rating.
Apart from Baird, Biohaven Ltd carries a moderate buy rating among 11 analysts covering the stock.
Asian Expansion
Vyglxia aside, Biohaven Ltd and its subsidiaries entered into a strategic licensing and collaboration agreement with Ono Pharmaceutical Co., Ltd. for the exclusive license to develop and commercialize Biohaven’s MoDE pan IgG degrader portfolio in Japan, South Korea, Taiwan, and countries within the Association of Southeast Asian Nations (ASEAN).
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The portfolio will involve BHV-1300, including next-generation follow-on degraders BHV-1310 and BHV-1320.
Under the terms of the agreement, Biohaven Ltd is set to receive $100 million in near-term payments, including $80 million upon closing and another $20 million upon a milestone achievement anticipated within a year. It will also receive royalties totaling 20 percent of net sales in the licensed territory.
Biohaven retains all rights to the MoDE IgG degrader portfolio outside of the licensed territory, including in the US, Europe, and China.
Hedge Funds Bullish
Institutional investors have already been bullish about Biohaven Ltd in the second quarter of the year, even prior to the FDA approval.
Data from Insider Monkey showed that 47 hedge funds held positions in the stock, unchanged from the first quarter of the year. However, their combined holdings notably soared by 94 percent to $667 million from $343 million year-on-year, signaling that investors are committing larger capital amid its long-term growth prospects.
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