Core Viewpoint - The Gross Law Firm has issued a notice to shareholders of Biohaven Ltd. regarding a class action lawsuit alleging that the company made materially false and misleading statements about its product candidates and their regulatory prospects [1][2]. Group 1: Allegations - The complaint claims that during the class period from March 24, 2023, to May 14, 2025, Biohaven overstated the regulatory prospects of its product candidate, troriluzole, as a treatment for SCA [1]. - It is alleged that the efficacy and clinical prospects of BHV-7000 for bipolar disorder were also overstated [1]. - The revelations of these overstated claims are likely to have a significant negative impact on Biohaven's business and financial condition [1]. Group 2: Class Action Details - Shareholders who purchased shares of BHVN during the specified class period are encouraged to register for the class action, with a deadline of September 12, 2025, to seek lead plaintiff status [2]. - Once registered, shareholders will be enrolled in a portfolio monitoring software to receive updates throughout the case lifecycle [2]. - Participation in the case incurs no cost or obligation for the shareholders [2]. Group 3: Law Firm Background - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting the rights of investors affected by deceit and illegal business practices [3]. - The firm aims to ensure companies adhere to responsible business practices and seeks recovery for investors who suffered losses due to misleading statements [3].

Core Viewpoint - A class action securities lawsuit has been filed against Biohaven Ltd. alleging securities fraud that negatively impacted investors between March 24, 2023, and May 14, 2025 [1][2]. Group 1: Lawsuit Details - The lawsuit claims that Biohaven Ltd. made false statements regarding the regulatory prospects of its product candidate, troriluzole, and the efficacy of BHV-7000 for bipolar disorder, which were overstated [2]. - The complaint suggests that the revelation of these misstatements is likely to have a significant negative impact on Biohaven's business and financial condition [2]. Group 2: Investor Information - Investors who suffered losses during the specified timeframe have until September 12, 2025, to request to be appointed as lead plaintiff, although participation does not require serving in this role [3]. - Class members may be entitled to compensation without any out-of-pocket costs or fees [3]. Group 3: Legal Firm Background - Levi & Korsinsky, LLP has a strong track record in securities litigation, having secured hundreds of millions of dollars for shareholders over the past 20 years [4]. - The firm has been recognized in ISS Securities Class Action Services' Top 50 Report for seven consecutive years as one of the leading securities litigation firms in the United States [4].

Core Viewpoint - A class action securities lawsuit has been filed against Biohaven Ltd. alleging securities fraud that negatively impacted investors between March 24, 2023, and May 14, 2025 [1][2]. Group 1: Lawsuit Details - The lawsuit claims that Biohaven Ltd. made false statements regarding the regulatory prospects of its product candidate, troriluzole, and overstated its efficacy for treating spinocerebellar ataxia (SCA) [2]. - It is alleged that the clinical prospects of another product, BHV-7000, for treating bipolar disorder were also overstated, which could significantly harm Biohaven's business and financial condition once revealed [2]. - The defendants' public statements are claimed to have been materially false and misleading throughout the relevant period [2]. Group 2: Next Steps for Investors - Investors who suffered losses during the specified timeframe have until September 12, 2025, to request to be appointed as lead plaintiff in the lawsuit [3]. - Participation in the lawsuit does not require serving as a lead plaintiff, and class members may be entitled to compensation without any out-of-pocket costs [3]. Group 3: Firm Background - Levi & Korsinsky, LLP has a strong track record in securities litigation, having secured hundreds of millions of dollars for shareholders over the past 20 years [4]. - The firm has been recognized as one of the top securities litigation firms in the United States for seven consecutive years [4].

Financial Performance - Net loss for the three months ended June 30, 2025, was $198,147,000, compared to a net loss of $319,771,000 for the same period in 2024, indicating a reduction of approximately 38.0%[14] - The company reported a comprehensive loss of $198,223,000 for the three months ended June 30, 2025, compared to a comprehensive loss of $319,743,000 for the same period in 2024, a decrease of approximately 38.0%[14] - The segment net loss for the six months ended June 30, 2025, was $419,824,000, compared to $499,275,000 for the same period in 2024, indicating a decrease of about 16%[190] - The Company reported a total consolidated net loss of $198,147,000 for the three months ended June 30, 2025, compared to $319,771,000 for the same period in 2024, reflecting a decrease of approximately 38%[190] Assets and Liabilities - Total current assets decreased from $538,472,000 as of December 31, 2024, to $474,827,000 as of June 30, 2025, a decline of approximately 11.8%[12] - Total liabilities increased significantly from $191,671,000 as of December 31, 2024, to $415,828,000 as of June 30, 2025, representing an increase of approximately 117.5%[12] - The company has a significant accumulated deficit of $1,765,538,000 as of June 30, 2025, compared to $1,345,714,000 as of December 31, 2024, an increase of approximately 31.1%[12] - As of June 30, 2025, total assets measured at fair value amounted to $401,063,000, with cash equivalents of $88,944,000 and marketable securities totaling $149,050,000[65] Cash Flow and Investments - Cash and cash equivalents increased from $102,542,000 at the beginning of the period to $168,997,000 at the end of the period, reflecting a net increase of $66,455,000[19] - The company incurred a net cash used in operating activities of $333,060,000 for the six months ended June 30, 2025, compared to $270,435,000 for the same period in 2024, indicating an increase in cash outflow[19] - Cash and cash equivalents included $165,797 as of June 30, 2025, down from $239,147 in the prior year, reflecting a decrease of 30.7%[39] - The Company reported net investment income of $4,153 for the three months ended June 30, 2025, down from $5,100 in the same period of 2024, representing a decline of 18.5%[56] Research and Development - Research and development expenses for the six months ended June 30, 2025, were $371,951,000, down from $470,791,000 for the same period in 2024, a decrease of approximately 21.0%[14] - Direct R&D program expenses for BHV-4157 (Troriluzole) were $14,245,000 for the three months ended June 30, 2025, down from $17,076,000 in 2024, a decline of approximately 17%[190] - R&D personnel expenses (excluding share-based compensation) for the six months ended June 30, 2025, were $41,627,000, compared to $37,202,000 in 2024, an increase of about 6%[190] - For the three months ended June 30, 2025, the Company recorded R&D expenses of $330,000, a decrease from $582,000 in the same period of 2024, representing a reduction of approximately 43%[185] Shareholder Equity and Stock Issuance - As of June 30, 2025, total shareholders' equity was $134,587, with a net loss of $198,147 for the quarter[98] - The Company issued 3,588,688 common shares as payment under license agreements, contributing $51,426 to equity[98] - The company raised approximately $247,830 from a public offering of 6,451,220 common shares at $41.00 per share on April 22, 2024[108] - The Company issued 1,872,874 common shares to Knopp, valued at approximately $65,981, as part of the Knopp Amendment in May 2024[102] Debt and Financing - The Company entered into a Note Purchase Agreement with a principal amount of $250,000, with an additional potential tranche of up to $150,000 contingent on FDA approval for troriluzole[40] - The Company entered into a Note Purchase Agreement on April 28, 2025, with an initial tranche of senior secured notes sold for an aggregate purchase price of $250,000[85] - A second tranche of up to $150,000 may be purchased, contingent upon FDA approval for troriluzole, with potential additional notes for $200,000 for permitted acquisitions[85] - The Company has granted a security interest in cash and equity interests related to troriluzole to secure obligations under the Note Purchase Agreement[93] Clinical Development and Regulatory Milestones - The NDA for Troriluzole in Spinocerebellar Ataxia has been accepted with priority review by the FDA, with a PDUFA date expected in Q4 2025[199] - The Company is advancing its innovative portfolio, including BHV-2000 (Taldefgrobep Alfa) for spinal muscular atrophy, with an FDA meeting scheduled in 1H 2025[198] - The pivotal Study BHV4157-206-RWE demonstrated a 50-70% slower rate of disease progression in SCA patients treated with troriluzole compared to untreated patients, translating to a delay of 1.5-2.2 years over the 3-year study period[205] - The study achieved its primary endpoint, showing statistically significant and sustained benefits on the f-SARA scale at years 1, 2, and 3 for patients treated with troriluzole[206] Legal Matters - A lawsuit was filed against the Company alleging federal securities law violations related to misstatements about BHV-7000's efficacy and clinical prospects[182]

Biohaven Second Quarter 2025 Business and Financial Update [Q2 2025 Key Highlights](index=1&type=section&id=Q2%202025%20Key%20Highlights) Biohaven ended Q2 2025 with **$408.2 million** cash, awaiting FDA decision for VYGLXIA, and reported significant clinical progress Financial Position as of June 30, 2025 | Metric | Value (USD) | | :--- | :--- | | Cash, cash equivalents, marketable securities and restricted cash | ~$408.2 million | - The New Drug Application (NDA) for VYGLXIA in spinocerebellar ataxia (SCA) is under review, with a PDUFA date set for **Q4 2025**[4](index=4&type=chunk) - MoDE degrader BHV-1300 demonstrated IgG reductions up to **87%** in Phase 1, while TRAP degrader BHV-1400 showed sustained Gd-IgA1 reductions over **80%**, highlighting potential in immune-mediated diseases[4](index=4&type=chunk) - The next-generation Trop2 ADC, BHV-1510, showed early clinical activity, with tumor reduction observed in the first **6 patients** treated in combination with cemiplimab[4](index=4&type=chunk) - A pivotal Phase 2/3 study was initiated for BHV-8000, a brain-penetrant TYK2/JAK1 inhibitor, in patients with Parkinson's disease[4](index=4&type=chunk) [CEO Commentary](index=1&type=section&id=CEO%20Commentary) CEO expressed optimism for VYGLXIA's decision and highlighted progress across I&I, Ion Channel, and Oncology platforms - The company is preparing for a potential commercial launch of VYGLXIA for spinocerebellar ataxia (SCA), pending FDA approval, to address a high unmet need[3](index=3&type=chunk)[5](index=5&type=chunk) - Progress in the Inflammation and Immunology (I&I) platform is highlighted by compelling data from MoDE/TRAP degraders (BHV-1300, BHV-1400) and the initiation of a pivotal study for the brain-penetrant TYK2/JAK1 inhibitor (BHV-8000) in Parkinson's disease[3](index=3&type=chunk) - The Ion Channel platform (Kv7) continues to advance, with promising early observations from the compassionate use of opakalim in a pediatric epilepsy patient[3](index=3&type=chunk) - The Oncology platform is generating promising early clinical data, with BHV-1510 showing tumor reduction in the first **six patients** treated with cemiplimab, and BHV-1530 (FGFR3-directed ADC) advancing into clinical testing[3](index=3&type=chunk) [Recent Business Highlights](index=2&type=section&id=Recent%20Business%20Highlights) Biohaven reported positive degrader data, advanced oncology, initiated Parkinson's study, and discontinued troriluzole for OCD - The MoDE program's BHV-1300 achieved IgG reductions up to **87%** in a Phase 1 multiple-dose study, suggesting potential for treating diseases like Graves' and rheumatoid arthritis[6](index=6&type=chunk) - The TRAP degrader BHV-1400 achieved rapid, deep, and sustained reductions in Gd-IgA1 of up to **81%** after a single dose in a Phase 1 study, targeting IgA Nephropathy[6](index=6&type=chunk) - The Trop2-directed ADC, BHV-1510, demonstrated early clinical activity, with tumor reduction in all **six** of the first patients treated in combination with cemiplimab[6](index=6&type=chunk) - A pivotal Phase 2/3 study of the brain-penetrant TYK2/JAK1 inhibitor, BHV-8000, was initiated for the treatment of early Parkinson's disease[6](index=6&type=chunk) - The Phase 3 trial of troriluzole in Obsessive-Compulsive Disorder (OCD) was completed with no efficacy signal detected, leading to the termination of the OCD development program[7](index=7&type=chunk) [Expected Upcoming Milestones](index=3&type=section&id=Expected%20Upcoming%20Milestones) Biohaven anticipates key milestones through 2026, including VYGLXIA PDUFA, registrational degrader studies, and BHV-7000 results - **VYGLXIA (Glutamate Modulator):** A PDUFA date for the SCA NDA is expected in **Q4 2025**, with the company preparing for a potential commercial launch[8](index=8&type=chunk) - **MoDE/TRAP Platforms:** A Phase 1b study for BHV-1300 in Graves' disease is set to begin in **2H 2025**, with a potentially registrational study also expected in **2H 2025**. A potentially registrational study for BHV-1400 (IgA nephropathy) is expected to start in **2026**[11](index=11&type=chunk) - **BHV-7000 (Kv7 Activator):** Pivotal topline results are anticipated in **2H 2025** for major depressive disorder and in **1H 2026** for focal epilepsy[11](index=11&type=chunk) - **Taldefgrobep alfa (Myostatin):** A Phase 2 study in obesity is expected to be initiated in **2H 2025**[11](index=11&type=chunk) - **ADC Platform:** Phase 1/2 studies with BHV-1510 and a Phase 1 study with BHV-1530 will continue to advance through **2025**[11](index=11&type=chunk) [Financial Performance](index=3&type=section&id=Financial%20Performance) This section details Biohaven's Q2 2025 financial position, operating expenses, net loss, and balance sheet [Capital Position](index=3&type=section&id=Capital%20Position) Biohaven maintained a strong capital position with approximately **$408.2 million** in cash and marketable securities as of June 30, 2025 Cash Position | Date | Metric | Value (USD) | | :--- | :--- | :--- | | June 30, 2025 | Cash, cash equivalents, marketable securities and restricted cash | ~$408.2 million | [Second Quarter 2025 Financial Highlights](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Highlights) Biohaven's Q2 2025 net loss narrowed to **$198.1 million** due to decreased R&D expenses, despite increased G&A Q2 Financial Performance (in millions, except per share data) | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | R&D Expenses | $184.4 | $314.8 | ($130.5) | | G&A Expenses | $27.3 | $19.0 | $8.4 | | Net Loss | ($198.1) | ($319.8) | $121.7 | | Net Loss Per Share | ($1.94) | ($3.64) | $1.70 | | Non-GAAP Adj. Net Loss | ($166.4) | ($308.6) | $142.2 | - The **$130.5 million** decrease in R&D expenses was primarily due to a one-time non-cash expense in Q2 2024 for a milestone and royalty buyback related to the BHV-7000 platform, partially offset by increased direct program costs in 2025[10](index=10&type=chunk)[12](index=12&type=chunk) - The **$8.4 million** increase in G&A expenses was mainly driven by higher non-cash share-based compensation and fees related to a Note Purchase Agreement entered into during Q2 2025[13](index=13&type=chunk) [Consolidated Statements of Operations](index=6&type=section&id=Consolidated%20Statements%20of%20Operations) Biohaven reported Q2 2025 total operating expenses of **$211.7 million** and a net loss of **$198.1 million**, a significant improvement Consolidated Statements of Operations Highlights (Unaudited, in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Research and development | $184,367 | $314,819 | | General and administrative | $27,334 | $18,953 | | **Total operating expenses** | **$211,701** | **$333,772** | | **Loss from operations** | **($211,701)** | **($333,772)** | | **Net loss** | **($198,147)** | **($319,771)** | | **Net loss per share** | **($1.94)** | **($3.64)** | [Consolidated Balance Sheets](index=7&type=section&id=Consolidated%20Balance%20Sheets) Biohaven's total assets decreased to **$550.4 million** as of June 30, 2025, with liabilities increasing to **$415.8 million**, reducing equity Consolidated Balance Sheet Highlights (Unaudited, in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $165,797 | $99,134 | | Marketable securities | $239,183 | $386,857 | | **Total current assets** | **$474,827** | **$538,472** | | **Total assets** | **$550,415** | **$615,107** | | Total current liabilities | $124,324 | $154,226 | | Notes payable | $257,070 | $— | | **Total liabilities** | **$415,828** | **$191,671** | | **Total shareholders' equity** | **$134,587** | **$423,436** | [Reconciliation of GAAP to Non-GAAP Financial Measures](index=8&type=section&id=Reconciliation%20of%20GAAP%20to%20Non-GAAP%20Financial%20Measures) Biohaven reconciled Q2 2025 GAAP net loss of **$198.1 million** to a non-GAAP adjusted net loss of **$166.4 million** GAAP to Non-GAAP Net Loss Reconciliation (Unaudited, in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | **GAAP net loss** | **($198,147)** | **($319,771)** | | Add: non-cash share-based compensation | $20,812 | $12,232 | | Add: loss from change in fair value of derivatives | $10,970 | ($1,040) | | **Non-GAAP adjusted net loss** | **($166,365)** | **($308,579)** | GAAP to Non-GAAP Net Loss Per Share Reconciliation (Unaudited) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | **GAAP net loss per share** | **($1.94)** | **($3.64)** | | Non-cash share-based compensation per share | $0.20 | $0.14 | | Loss from change in fair value of derivatives per share | $0.11 | ($0.01) | | **Non-GAAP adjusted net loss per share** | **($1.63)** | **($3.52)** |

Core Insights - Biohaven Ltd. reported its financial results for Q2 2025, highlighting significant progress in clinical development and upcoming regulatory decisions, particularly regarding VYGLXIA® for spinocerebellar ataxia (SCA) [1][2][3] Financial Performance - Cash, cash equivalents, marketable securities, and restricted cash totaled approximately $408.2 million as of June 30, 2025 [4][10] - R&D expenses were $184.4 million for Q2 2025, a decrease from $314.8 million in Q2 2024, primarily due to a one-time non-cash expense in the previous year [11] - General and administrative expenses increased to $27.3 million in Q2 2025 from $19.0 million in Q2 2024, attributed to higher non-cash share-based compensation and legal costs [12] - The net loss for Q2 2025 was $198.1 million, or $1.94 per share, compared to a net loss of $319.8 million, or $3.64 per share, in Q2 2024 [14][20] Clinical Development Highlights - The VYGLXIA NDA for SCA has a PDUFA date set for Q4 2025, with clinical trial inspections completed without observations [4][7] - BHV-1300, a MoDE degrader, showed IgG reductions of up to 87% in Phase 1 trials, indicating potential for treating IgG-mediated diseases [4][5] - BHV-1400, a TRAP degrader, achieved sustained reductions in Gd-IgA1 of over 80%, highlighting its potential for IgA Nephropathy treatment [4][5] - BHV-1510 demonstrated tumor reduction in all six patients treated in a Phase 1/2 study, indicating promising early clinical activity [4][9] - A pivotal Phase 2/3 study for BHV-8000 in Parkinson's disease has been initiated, targeting critical inflammatory pathways [4][7] Upcoming Milestones - Biohaven is preparing for the potential commercial launch of VYGLXIA if approved, with continued excellence in study execution and patient enrollment expected [2][7] - The company anticipates initiating a Phase 2 study in obesity in the second half of 2025 and a pivotal major depressive disorder topline result in the same timeframe [7][8]

Core Viewpoint - The complaint against Biohaven alleges violations of federal securities laws due to misleading statements regarding the regulatory prospects of its drug troriluzole for spinocerebellar ataxia (SCA) and BHV-7000 for bipolar disorder, which could significantly impact the company's business and financial condition [2]. Group 1 - Biohaven's stock price fell by $3.84 per share, or 19.53%, closing at $15.82 per share following the announcement of an extended PDUFA date for the troriluzole NDA, indicating market reaction to regulatory uncertainties [3]. - The FDA extended the PDUFA date for the troriluzole NDA by three months to allow for a full review of recent submissions, and an advisory committee meeting is planned but not yet scheduled [3]. Group 2 - The lead plaintiff in the class action is the investor with the largest financial interest in the relief sought, who will oversee the litigation on behalf of the class [4]. - Any member of the putative class can move to serve as lead plaintiff or remain an absent class member without affecting their ability to share in any recovery [4]. Group 3 - Faruqi & Faruqi, LLP is encouraging individuals with information regarding Biohaven's conduct to come forward, including whistleblowers and former employees [5].

Core Viewpoint - A class action securities lawsuit has been filed against Biohaven Ltd. alleging securities fraud that negatively impacted investors between March 24, 2023, and May 14, 2025 [1][2]. Group 1: Lawsuit Details - The lawsuit claims that Biohaven Ltd. made false statements regarding the regulatory prospects of its product candidate, troriluzole, and the efficacy of BHV-7000 for bipolar disorder, which were overstated [2]. - The complaint suggests that the revelation of these misstatements is likely to have a significant negative impact on Biohaven's business and financial condition [2]. Group 2: Investor Information - Investors who suffered losses during the specified timeframe have until September 12, 2025, to request to be appointed as lead plaintiff, although participation in any recovery does not require this [3]. - Class members may be entitled to compensation without any out-of-pocket costs or fees [3]. Group 3: Legal Firm Background - Levi & Korsinsky, LLP has a strong track record in securities litigation, having secured hundreds of millions of dollars for shareholders over the past 20 years [4]. - The firm has been recognized as one of the top securities litigation firms in the United States for seven consecutive years [4].

Core Viewpoint - The Gross Law Firm has issued a notice to shareholders of Biohaven Ltd. regarding a class action lawsuit due to alleged misleading statements and omissions related to the company's product candidates and their regulatory prospects [1][3]. Summary by Relevant Sections Class Period and Allegations - The class period for the lawsuit is from March 24, 2023, to May 14, 2025 [3]. - Allegations include that Biohaven overstated the regulatory prospects of its product candidate, troriluzole, for treating SCA, and the efficacy of BHV-7000 for bipolar disorder [3]. - The complaint claims that these misrepresentations are likely to have a significant negative impact on Biohaven's business and financial condition once revealed [3]. Next Steps for Shareholders - Shareholders are encouraged to register for the class action by September 12, 2025, to potentially be appointed as lead plaintiff [4]. - Registration will provide shareholders with portfolio monitoring software for status updates throughout the case [4]. Law Firm's Mission - The Gross Law Firm aims to protect the rights of investors affected by deceit and fraud, ensuring companies adhere to responsible business practices [5].

Core Points - A class action lawsuit has been filed against Biohaven Ltd. in the U.S. District Court for the District of Connecticut on behalf of investors who acquired Biohaven securities during the period from March 24, 2023, to May 14, 2025 [1][3] - Investors have until September 12, 2025, to apply to the Court to be appointed as lead plaintiff in the lawsuit [1][3] Allegations - The lawsuit claims that Biohaven made false or misleading statements regarding the likelihood of regulatory approval for its drug troriluzole to treat SCA, as well as the strength of the supporting data [4] - Additionally, it is alleged that Biohaven overstated the effectiveness and clinical potential of BHV-7000 as a treatment for bipolar disorder [4]