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Biohaven Highlights Portfolio Progress, Positive Early Patient Data from Priority Degrader Programs and Anticipated Milestones at the 44th Annual J.P. Morgan Healthcare Conference
Prnewswire· 2026-01-12 16:15
Core Insights - Biohaven is advancing a broad portfolio of innovative therapies targeting various diseases, with significant milestones expected in 2026 [6][35]. Group 1: Clinical Programs and Developments - Biohaven plans to initiate a pivotal study of BHV-1300 for Graves' disease in 2026, with early clinical data showing complete suppression of pathogenic antibodies and normalization of thyroid hormones within weeks [1][16]. - The BHV-1400 program for IgA nephropathy has demonstrated rapid clinical improvements, including a mean reduction of over 60% in disease-causing proteins and significant improvements in kidney function within weeks of dosing [12][13]. - Opakalim, a selective Kv7 channel activator for focal epilepsy, has shown a 50% responder rate in participants after six months of treatment, with pivotal results expected in 2026 [20][21]. - The obesity program featuring taldefgrobep, a myostatin-activin inhibitor, has begun Phase 2 studies, targeting significant weight loss and muscle gain, with topline results anticipated in 2026 [25][28]. Group 2: Innovative Platforms and Technologies - Biohaven's proprietary MoDE and TRAP degrader platforms focus on the selective removal of disease-causing proteins, representing a transformative approach in precision immunology [8][10]. - The company has established collaborations, including a memorandum of understanding with KAUST, to enhance the development of next-generation degraders [9]. - Biohaven's next-generation antibody drug conjugates (ADCs), such as BHV-1510 and BHV-1530, are showing promising clinical activity and safety profiles, with ongoing studies in various cancer types [29][31]. Group 3: Future Outlook and Strategic Goals - The company aims to transform immunological disease therapy by selectively targeting and removing disease-causing proteins, fulfilling the potential of precision immunology [5][14]. - Biohaven is committed to addressing high unmet medical needs across its clinical-stage portfolio, with a focus on innovative treatments for autoimmune diseases, obesity, and neurological disorders [6][35].
Outlook Therapeutics, Intelligent Bio Solutions And Other Big Stocks Moving Lower In Friday's Pre-Market Session - Biohaven (NYSE:BHVN), Cango (NYSE:CANG)
Benzinga· 2026-01-02 13:02
Core Viewpoint - U.S. stock futures are showing positive movement, particularly with Nasdaq 100 futures increasing by approximately 1% on Friday, while Outlook Therapeutics Inc faces significant stock decline due to FDA's response on its biologics license application [1]. Company Specifics - Outlook Therapeutics Inc (NASDAQ:OTLK) experienced a sharp decline of 60.9%, dropping to $0.62 in pre-market trading after the FDA issued a complete response letter regarding its ONS-5010/LYTENAVA application for treating wet age-related macular degeneration, indicating that the application cannot be approved in its current form [2][1]. - Intelligent Bio Solutions Inc (NASDAQ:INBS) saw a decrease of 19.2%, falling to $7.70 in pre-market trading following the announcement of a $10 million private placement priced at-the-market under Nasdaq rules [3]. - Net Lease Office Properties (NYSE:NLOP) shares dipped by 8.9% to $23.50 in pre-market trading [3]. - Progressive Corp (NYSE:PGR) tumbled by 5.8% to $214.60 in pre-market trading [3]. - Old Republic International Corp (NYSE:ORI) slipped by 4.8% to $43.42 in pre-market trading [3]. - Cango Inc – ADR (NYSE:CANG) fell by 4% to $1.44 in pre-market trading [3]. - Xeris Biopharma Holdings Inc (NASDAQ:XERS) decreased by 3.6% to $7.57 in pre-market trading after a previous gain of over 7% on Wednesday [3]. - Biohaven Ltd (NYSE:BHVN) fell by 2.6% to $11.00 in pre-market trading [3]. - RealReal Inc (NASDAQ:REAL) slipped by 2.3% to $15.41 in pre-market trading [3].
H.C. Wainwright Maintains Neutral Stance on Biohaven After BHV-7000 Setback
Financial Modeling Prep· 2025-12-26 18:27
Core Viewpoint - H.C. Wainwright reiterated a Neutral rating and $11 price target on Biohaven Pharmaceutical Holding Co. following disappointing clinical results for BHV-7000 in major depressive disorder [1] Group 1: Clinical Trial Results - The study for BHV-7000 failed to meet its primary endpoint of improvement in MADRS scores over six weeks compared to placebo [3] - Secondary endpoints, including CGI-S and SHAPS, were also missed in the trial [3] - Biohaven plans to conduct additional subgroup analyses, but these will be exploratory only, with no further trials planned for the program [3] Group 2: Market Focus and Future Directions - Investor attention has largely shifted to the upcoming focal onset seizure readout, with some investors hoping for positive MDD data as a catalyst [2] - Biohaven intends to redirect focus toward priority areas in 2026, including immunology, obesity, and epilepsy [4] - The results of BHV-7000 did not materially affect expectations for Xenon Pharmaceuticals' azetukalner Phase 3 MDD program [4]
Biohaven Stock Gaps Lower on Failed Phase 2 Drug Trial
Schaeffers Investment Research· 2025-12-26 15:25
Core Viewpoint - Biohaven Ltd's stock has declined 3.2% to $10.46 following reports that its drug for treating major depressive disorder failed to meet the primary goal of a phase 2 trial [1] Group 1: Stock Performance - The stock has faced overhead pressure at $12 for several weeks and has been on a downtrend throughout the year, reaching a three-year low of $7.49 on November 11 [1] - Year-to-date, Biohaven Ltd has lost over 70% of its value [1] Group 2: Analyst Ratings and Price Targets - Despite the stock's poor performance, 11 out of 18 analysts maintain a "strong buy" rating, with a 12-month consensus target price of $19.80, representing an 83.2% premium to current levels [2] Group 3: Options Activity - Recent options activity shows a preference for calls, with traders buying 7,974 calls compared to 2,150 puts over the past two weeks [2] - However, today's options trading indicates a higher volume of puts, with 2,105 calls and 3,034 puts traded, which is seven times the intraday average [3] - The most active option is the January 16, 2026, 10-strike put [3]
US Stocks Mixed; Biohaven Shares Fall
Benzinga· 2025-12-26 14:45
Market Overview - U.S. stocks showed mixed performance with the Dow Jones index decreasing by approximately 0.1% to 48,698.11, while the NASDAQ increased by 0.12% to 23,641.67 and the S&P 500 rose by 0.11% to 6,939.71 [1] - In the sector performance, information technology shares rose by 0.4%, while industrials stocks fell by 0.2% [1] Company News - Biohaven Ltd. (NYSE:BHVN) shares declined after the company reported that its Phase 2 study for BHV-7000, aimed at treating major depressive disorder, did not meet its primary endpoint as measured by the Montgomery Åsberg Depression Rating Scale [2] - A SPAC III Acquisition Corp (NASDAQ:ASPC) saw its shares surge by 82% to $24.38 [8] - Davis Commodities Limited (NASDAQ:DTCK) shares increased by 77% to $0.4209 following the release of its first-half fiscal unaudited financial results [8] - ECD Automotive Design, Inc. (NASDAQ:ECDA) shares rose by 57% to $1.2338 after announcing an expansion of its product lineup for 2026 [8] - Aptevo Therapeutics Inc. (NASDAQ:APVO) shares fell by 31% to $0.6451 due to a 1-for-18 reverse stock split [8] - Kaival Brands Innovations Group, Inc. (NASDAQ:KAVL) shares decreased by 12% to $0.1360 [8] - Kandal M Venture Limited (NASDAQ:FMFC) shares dropped by 12% to $0.3450 after a previous increase of over 28% [8] Commodity Market - In commodity trading, oil prices fell by 0.4% to $58.14, while gold prices increased by 1.2% to $4,555.30 [4] - Silver prices decreased by 4% to $74.515, whereas copper prices rose by 3% to $5.7445 [4] European Market - European shares exhibited mixed results with the eurozone's STOXX 600 gaining 0.1%, while Spain's IBEX 35 Index fell by 0.1% [5] - London's FTSE 100 decreased by 0.19%, Germany's DAX 40 rose by 0.23%, and France's CAC 40 slipped by 0.01% [5] Asian Market - Asian markets closed mixed with Japan's Nikkei 225 gaining 0.68%, China's Shanghai Composite rising by 0.10%, and India's BSE Sensex falling by 0.43% [6]
Cautiously Bullish After Biohaven's Cash Runway And Dilution Risk Rise
Seeking Alpha· 2025-12-26 14:24
Company Overview - Biohaven Ltd. (BHVN) is a clinical-stage biopharmaceutical company with a diverse pipeline focused on neuroscience, immunology, muscle and metabolism, and oncology [1]. Recent Developments - The Phase 2 depression trial for Opakalim (BHV-7000) did not meet its primary endpoint, leading the company to discontinue its psychiatric research [1].
抑郁症新药II期试验失败,Biohaven(BHVN.US)盘前暴跌近13%!华尔街为何集体“辩护”?
Zhi Tong Cai Jing· 2025-12-26 13:45
Core Viewpoint - Biohaven's stock dropped nearly 13% following the announcement of the failure of its Phase II clinical trial for the antidepressant candidate BHV-7000, leading the company to halt further clinical trials for psychiatric candidates [1][2] Group 1: Clinical Trial Results - The Phase II proof-of-concept study for BHV-7000 did not meet its primary endpoint in treating major depressive disorder [1] - Analysts noted that expectations for the success of the BHV-7000 trial were already low prior to the announcement [1][2] Group 2: Analyst Ratings and Perspectives - Citigroup analyst Samantha Semenkow maintained a "Buy" rating for Biohaven, emphasizing that the disappointing trial data was anticipated [1] - William Blair's Myles Minter rated Biohaven "In Line with the Market," citing increased difficulty in clinical trial execution and enhanced placebo effects as contributing factors [1] - RBC Capital Markets analyst Leonid Timashev suggested that the current setback may be a one-time event, potentially clearing the way for more promising catalysts in 2026 [2] Group 3: Future Focus - Biohaven is shifting its focus to the upcoming topline data from two key studies expected in the first half of 2026, particularly regarding the efficacy of BHV-7000 in treatment-resistant focal epilepsy patients [1][2] - Analysts recommend that investors concentrate on the potential opportunities in the focal epilepsy space, with critical data anticipated in 2026 [2]
Biohaven Misses The Mark In Depression Trial, Stock Falls
Benzinga· 2025-12-26 13:20
Core Insights - Biohaven Ltd. reported results from a Phase 2 proof-of-concept study for BHV-7000 targeting major depressive disorder (MDD), which did not meet its primary endpoint of reducing depressive symptoms compared to placebo [1] Study Results - The study showed trends favoring BHV-7000 in clinically relevant subgroups, particularly among participants with more severe depression at screening and baseline [2] - BHV-7000 was found to be safe and well-tolerated, with adverse events primarily mild to moderate and largely resolving spontaneously [3] Strategic Focus - The company views the subgroup analyses as hypothesis-generating but plans to prioritize resources on key areas such as immunology, obesity, and epilepsy, foregoing additional psychiatric clinical trials [4] Analyst Commentary - Analysts consider the Phase 2 miss a setback but not unexpected, citing ongoing challenges in MDD trials, including execution risk and rising placebo response [5] - Concerns remain regarding the efficacy of the extended-release formulation of opakalim, as no efficacy signal was observed and adverse event rates were similar between BHV-7000 and placebo [6] - Caution is advised against overinterpretation of favorable signals in severely depressed patients due to the small sample size in the analysis [7] Market Reaction - Following the news, Biohaven shares fell by 15.45% to $9.14 in premarket trading [8]
Stock Market Today: Dow Jones, S&P 500 Futures Slip After Christmas Day—Nvidia, Sobr Safe, Biohaven In Focus - SPDR S&P 500 (ARCA:SPY)
Benzinga· 2025-12-26 10:09
Market Overview - U.S. stock futures declined on Friday following a higher close on Wednesday, with major benchmark indices showing a decrease [1][2] - The Dow Jones futures fell by 0.12%, S&P 500 by 0.06%, Nasdaq 100 by 0.06%, and Russell 2000 by 0.27% [2] - The SPDR S&P 500 ETF Trust (SPY) decreased by 0.029% to $690.18, while Invesco QQQ Trust ETF (QQQ) fell by 0.014% to $623.84 in premarket trading [2] Economic Data - U.S. initial jobless claims dropped by 10,000 to 214,000 for the week ending Dec. 20, better than market expectations of 223,000 [1] - The 10-year Treasury bond yield was at 4.15%, and the two-year bond yield was at 3.51% [2] - The CME Group's FedWatch tool indicates an 84.5% probability that the Federal Reserve will keep interest rates unchanged in January [2] Company Highlights - Dynavax Technologies (NASDAQ:DVAX) shares surged by 38.19% following Sanofi's announcement to acquire the vaccines company [5] - Davis Commodities Ltd. (NASDAQ:DTCK) reported revenue of $95 million for the six months ending June 30, a 42.1% increase from $66.9 million a year earlier, leading to a 7.19% rise in its shares [4] - Nvidia Corp. (NASDAQ:NVDA) shares rose by 0.58% after announcing a non-exclusive licensing agreement with AI chip startup Groq [5] - Sobr Safe Inc. (NASDAQ:SOBR) shares dropped by 15.61% after announcing a private placement of 1.29 million shares at $1.55 per share [5][6] - Biohaven Ltd. (NYSE:BHVN) shares fell by 14.06% after its Phase 2 study of BHV-7000 in major depressive disorder failed to meet its primary endpoint [13] Analyst Insights - University of Michigan economist Justin Wolfers criticized the media's focus on record stock numbers, stating that U.S. markets are up 18% but lag behind global markets, which have risen by 30% [9][10] - Wolfers highlighted a disconnect between GDP growth of over 4% and a more modest Gross Domestic Income (GDI) growth of 2.4%, suggesting potential job creation stagnation [10]
Stock Market Today: Dow Jones, S&P 500 Futures Slip After Christmas Day—Nvidia, Sobr Safe, Biohaven In Focus
Benzinga· 2025-12-26 10:09
Market Overview - U.S. stock futures declined on Friday following a higher close on Wednesday, with major benchmark indices showing a decrease [1][2] - The Dow Jones futures fell by 0.12%, S&P 500 by 0.06%, Nasdaq 100 by 0.06%, and Russell 2000 by 0.27% [2] - The SPDR S&P 500 ETF Trust (SPY) decreased by 0.029% to $690.18, while Invesco QQQ Trust ETF (QQQ) fell by 0.014% to $623.84 in premarket trading [2] Economic Data - U.S. initial jobless claims dropped by 10,000 to 214,000 for the week ending Dec. 20, better than market estimates of 223,000 [1] Company Highlights - Dynavax Technologies (NASDAQ:DVAX) shares surged by 38.19% following Sanofi's announcement to acquire the vaccines company [5] - Davis Commodities Ltd. (NASDAQ:DTCK) reported revenue of $95 million for the six months ending June 30, a 42.1% increase from $66.9 million a year earlier, leading to a 7.19% rise in its shares [4] - Nvidia Corp. (NASDAQ:NVDA) shares rose by 0.58% after announcing a non-exclusive licensing agreement with AI chip startup Groq [5] - Sobr Safe Inc. (NASDAQ:SOBR) shares dropped by 15.61% after announcing a private placement of 1.29 million shares at $1.55 per share [5][6] - Biohaven Ltd. (NYSE:BHVN) shares fell by 14.06% after its Phase 2 study of BHV-7000 in major depressive disorder failed to meet its primary endpoint [13] Analyst Insights - University of Michigan economist Justin Wolfers criticized the media's focus on record stock numbers, stating that U.S. markets are up 18% but lag behind global markets, which have risen by 30% [9] - Wolfers highlighted a disconnect between GDP growth of over 4% and Gross Domestic Income (GDI) growth of only 2.4%, suggesting potential job creation stagnation [10]