Latest news with #BHVN
Yahoo
29-05-2025
- Business
- Yahoo
Biohaven Ltd. (BHVN)'s BHV-1400 Cuts Disease Antibody by 81% in IgA Nephropathy
Biohaven Ltd. (NYSE:BHVN) has announced major breakthroughs with its novel precision immunology therapies, BHV-1400 and BHV-1300, at its 2025 R&D Day in New Haven. BHV-1400, a first-in-class TRAP degrader, achieved up to 81% reduction in galactose-deficient IgA1 (Gd-IgA1), the key driver of IgA nephropathy (IgAN), after a single subcutaneous dose, with effects lasting for weeks. A patient viewing their medical diagnosis on a digital healthcare ecosystem. Unlike traditional immunosuppressive treatments, BHV-1400 precisely eliminates pathogenic Gd-IgA1 while sparing healthy antibodies (IgA, IgG, IgE, IgM), preserving overall immune function and offering a superior safety profile. This selectivity sets it apart from complement and BLyS/APRIL inhibitors, which can compromise broader immunity. Encouraged by these results, Biohaven Ltd. (NYSE:BHVN) will launch a pivotal IgAN trial in 2026 using the urine protein-creatinine ratio as an accelerated approval endpoint. Simultaneously, BHV-1300, targeting IgG-mediated diseases like Graves' Disease, demonstrated rapid, deep, and sustained total IgG reductions of up to 87% in Phase 1, with flexible dosing for acute and chronic management. Both therapies were well-tolerated, with no serious adverse events. Biohaven Ltd. (NYSE:BHVN) plans pivotal trials for BHV-1300 in Graves' Disease in the second half of 2025, reinforcing its leadership in precision immunology. While we acknowledge the potential of BHVN to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than BHVN and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Sign in to access your portfolio
Business Insider
15-05-2025
- Business
- Business Insider
FDA extends PDUFA for Biohaven's Troriluzole new drug application
The company states: 'Biohaven (BHVN) announced that the Division of Neurology 1 within FDA's Office of Neuroscience informed the Company that they are extending the PDUFA date for the troriluzole new drug application for the treatment of spinocerebellar ataxia, SCA, by three months to provide time for a full review of Biohaven's recent submissions related to information requests from the FDA. The Division also informed Biohaven that it is currently planning to hold an advisory committee meeting to discuss the application, but no date has been scheduled. The FDA did not raise any new concerns in the letter. The FDA's decision regarding the NDA is now expected in 4Q 2025. Biohaven previously received Fast-Track, Orphan Drug Designation and Priority Review from the FDA regarding troriluzole for SCA. Priority Review designation is assigned to applications for drugs that would offer a significant improvement over other available treatments for a given disorder or would provide a treatment option where none exists. In the case of SCA, a rare, genetic, neurodegenerative disease, troriluzole would be the first and only FDA-approved treatment for this life-threatening disorder.' Confident Investing Starts Here:
Yahoo
26-04-2025
- Business
- Yahoo
Biohaven share price undervaluing pipeline potential, says RBC Capital
RBC Capital after notes released by the European Medicines Agency's CHMP indicated that Biohaven (BHVN) had withdrawn the application for troriluzole in spinocerebellar ataxia. Investor sentiment has been more bearish lately, with most believing that SCA approval in the U.S. is critical to helping the stock recover, notes the firm, which believes this news 'puts additional pressure' on that and explains the outsized stock move. However, it also believes the EMA has been a stricter regulator on rare diseases of late compared to the FDA, which could limit readthroughs While 'some downside is warranted on the news' in the range of 6%-7%), the firm still thinks the current share price undervalues upside on a U.S. approval in SCA and Biohaven's pipeline opportunities, adds the analyst, who has an Outperform rating and $61 price target on the shares. Discover outperforming stocks and invest smarter with Top Smart Score Stocks. Filter, analyze, and streamline your search for investment opportunities using Tipranks' Stock Screener. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See Insiders' Hot Stocks on TipRanks >> Read More on BHVN: Disclaimer & DisclosureReport an Issue Biohaven down 12% to $20.60 after pulling European application Biohaven trading resumes Biohaven withdraws troriluzole marketing application in Europe Biohaven trading halted, volatility trading pause RBC sees Makary interview as potentially positive for biotech stocks Sign in to access your portfolio
Yahoo
01-04-2025
- Business
- Yahoo
American Century Companies boosts stake in Biohaven, ETF Daily News says
American Century Companies has boosted its stake in Biohaven (BHVN) by 9.5% during Q4, ETF Daily News reports, citing a recent SEC filing. The firm owned 558,761 shares of Biohaven after purchasing an additional 48,286 shares during the period, the report notes. Discover the latest stocks recommended by top Wall Street analysts, all in one place with Analyst Top Stocks. Make smarter investments with weekly expert stock picks from the Smart Investor Newsletter. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See today's best-performing stocks on TipRanks >> Read More on BHVN: Disclaimer & DisclosureReport an Issue Biohaven falls -10.9% Immunovant data positive for Biohaven, says Deutsche Bank Positive Outlook for Biohaven Ltd. Amid Promising Developments and FDA Priority Review Biotech Alert: Searches spiking for these stocks today Optimistic Buy Rating for Biohaven Ltd. Amid Promising Drug Developments and Strategic Pipeline Advancements
