Filings & news by date
Hover (PC) or tap (mobile) a candle to see that day only
Biohaven Ltd.Bullish
Biohaven announced that the FDA has accepted for review the resubmitted New Drug Application (NDA) for Vyglxia (troriluzole) for the treatment of spinocerebellar ataxia (SCA). The FDA considers the resubmission a complete response to the November 4, 2025, action letter and has set a user fee goal date in the first quarter of 2027, with an upcoming advisory committee meeting planned.…more
Biohaven Ltd.
Biohaven has entered into an exclusive licensing agreement with Ono Pharmaceutical for its MoDE IgG degrader portfolio, including BHV-1300, BHV-1310, and BHV-1320, covering Japan and select Asian regions. Biohaven will receive an $80 million upfront payment, up to $20 million in milestone payments, and approximately 20% royalties on net sales in the licensed territory. Biohaven retains all rights to the portfolio outside of the licensed territory, including in the U.S., Europe, and China.…more
Biohaven Ltd.
Biohaven Ltd. executive Kimberly Gentile filed an SEC Form 4 on September 17, 2026, reporting a change in beneficial ownership of securities as of September 15, 2026. This filing serves as a standard disclosure of insider equity holdings.…more
17 more filings
Sign up free to unlock the full feed and real-time filing & news alerts.
Biohaven Surges as FDA Accepts Resubmission for Rare Disease Drug
Biohaven shares rallied after the FDA accepted the company's resubmission for its rare disease drug, Vyglxia, for regulatory review. The agency plans to convene an advisory committee to further evaluate the clinical data provided.…more
●●●●●●●● ●●●●● ●●●●●●
Biohaven has successfully resubmitted its New Drug Application for troriluzole to treat spinocerebellar ataxia. The FDA's acceptance of the filing marks a significant step forward in the company's regulatory process.…more
●●●●●●●● ●●●●● ●●●●●●
Biohaven has signed a licensing and collaboration agreement with Ono Pharmaceutical to develop and commercialize its IgG degrader portfolio in select Asian territories. The deal provides Biohaven with up to $100 million in near-term payments and potential royalties on future net sales.…more
2 more news items
Sign up free to unlock the full feed and real-time filing & news alerts.