Latest news with #Biohaven
Yahoo
3 days ago
- Business
- Yahoo
In Your Neighborhood: Kathryn Hauser at MADE Leadership Series event at Yale Innovation Summit
NEW HAVEN, Conn. (WTNH) — News 8's Kathryn Hauser emceed the second MADE Leadership series on Wednesday in New Haven. The series was held at the Yale Innovation Summit and featured discussions on the state of innovation in Connecticut. The panel was moderated by the state's Chief Innovation Officer and Department Of Economic and Community Development Commissioner Dan O'Keefe. Also on the panel were CEOs of Biohaven, BioCT and QuantumCT. 'For me, innovation is not just disrupting, but it's actually solving big patient problems and healthcare problems, said Biohaven CEO Dr. Vlad Coric. The Yale Innovation Summit is a two-day event that features exhibits, discussions and dynamic experiences. 'What I love about Connecticut, is we all band together to really lure the companies,' said BioCT CEO Jodie Gillion. 'We can get together with Yale, with the state, with Connecticut innovations and all different groups and really put on a good show.' The next MADE Leadership Series event will take place in October in Fairfield County. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Yahoo
3 days ago
- Business
- Yahoo
Biohaven Highlights Innovation and Advancement Across MoDE and TRAP Degrader Platform at R&D Day, Announcing Positive TRAP Degrader Data Achieving > 80% Sustained Reductions in Galactose-Deficient IgA1 (Gd-IgA1) with Potential First-in-Class BHV-1400 for IgA Nephropathy (IgAN)
Optimized subcutaneous (SC) administration of BHV-1400 achieved rapid, deep, selective, and sustained lowering of Gd-IgA1, differentiating Biohaven's leading TRAP degrader for IgAN from the complement and BLyS/APRIL inhibitor competition. Up to 81% reduction of Gd-IgA1 was observed, with reductions from baseline sustained for weeks after a single SC dose administration. BHV-1400 brings precision immunology to the treatment landscape of IgAN as it was rationally designed to selectively remove galactose-deficient IgA1 (Gd-IgA1), the pathogenic antibody driver of the disease while sparing healthy antibodies IgA, IgG, IgE, and IgM. Preservation of immunoglobulins, the complement system, and cell-mediated and humoral immunity offers key differentiation against immunosuppressive BLyS/APRIL inhibitors, complement inhibitors, and budesonide. Based upon the rapid and deep reductions of Gd-IgA1 observed with subcutaneous BHV-1400, Biohaven plans to study BHV-1400 in patients with IgAN, initiating a pivotal trial in 2026 using urine protein-creatinine ratio (UPCR) as a surrogate endpoint for accelerated approval. Optimized SC administration of BHV-1300 has continued to demonstrate rapid, deep, and sustained lowering of total IgG in Phase 1 studies. Recently generated clinical data shows that BHV-1300 achieved rapid, deep, and sustained lowering of total IgG, with reductions up to 87%. Median maximum reductions of 83% were observed within 18 days of the first subcutaneous dose. The range of IgG reductions possible with varying dosing paradigms of BHV-1300 allows for tunable dosing regimens tailored for acute and chronic disease management, with higher doses for acute disease management and lower, less frequent dosing for chronic disease management. Based upon the rapid and deep reductions of IgG and favorable tolerability profile observed with BHV-1300, Biohaven plans to study BHV-1300 in patients with Graves' Disease and initiate pivotal trials in 2H 2025. NEW HAVEN, Conn., May 28, 2025 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) ("Biohaven"), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today highlighted the success of its first MoDE™ and TRAP™ degraders in achieving key target pharmacodynamic endpoints and announced plans to initiate pivotal trials in Graves' Disease and in IgA nephropathy in 2H 2025 and 1H 2026, respectively at Biohaven's 2025 R&D Day, held concurrently with the Yale Innovation Summit in New Haven, Connecticut. The presentation slides from Biohaven's R&D day for the TRAP and MoDE degraders and its other platforms will be available on the Events and Presentations page of the Biohaven website just prior to their presentations. BHV-1400, the Company's potential first-in-class galactose-deficient IgA1 (Gd-IgA1) TRAP degrader for the treatment of IgA nephropathy (IgAN) achieved deep, rapid, and sustained reductions in Gd-IgA1. In the Phase 1 study, a single dose of BHV-1400 was subcutaneously administered at a dose of 500 mg and achieved rapid, deep and sustained reductions in Gd-IgA1 of up to 81%, with a median reduction of 66% (Figure 1). Reductions occurred within hours of each dose, were progressive, and were sustained for weeks after a single dose administration. Effects were selective, with no significant reductions observed in other immunoglobulins: IgA, IgG, IgE, or IgM. Dr. Jonathan Barratt, the Mayer Professor of Renal Medicine at University of Leicester and leading expert in the treatment of IgAN, commented on the new Phase 1 data, "The reason I am excited about BHV-1400 is because it specifically targets the fundamental abnormality in IgA nephropathy while leaving the rest of the immune system untouched. It has the potential to take away the major driver for immune complex formation while leaving other antibodies completely unaffected, which means it has efficacy with unrivaled safety." IgA nephropathy is the leading cause of glomerular disease globally and is commonly diagnosed in individuals in their second and third decades of life, with most individuals progressing to renal failure over the ensuing 10-15 years. As a disease of the immune system, IgA nephropathy frequently returns even after renal transplant. While the 2021 Kidney Disease Improving Global Outcomes (KDIGO) treatment guidelines recommended only standard chronic kidney disease treatments, the 2024 draft guidelines emphasize the importance of treating the underlying immune disease by removing aberrant forms of IgA. "Galactose deficient IgA1 is the fundamental abnormality in IgA nephropathy," Dr. Barratt explained, "It's a group of IgA molecules that have changes to the sugars on the IgA1 hinge region that fundamentally change the way this antibody behaves. It promotes immune complex formation and it's these immune complexes that cause glomerular injury and damage and promote loss of kidney function." BHV-1400's selective approach has the potential to offer an improved safety profile compared to broadly immunosuppressive agents. BHV-1400 has been safe and well-tolerated across the ongoing Phase 1 study. Most adverse events (AEs) were mild and self-resolving, there were no discontinuations due to AEs related to study drug, and there were no serious or severe AEs related to drug. There were no clinically significant increases in ALT, AST or bilirubin, no clinically significant reductions in albumin and no clinically significant increases in cholesterol relative to placebo over the 4-week dosing period. There were no clinically significant reductions in other immunoglobulins including IgG, IgA, IgE, or IgM relative to baseline. With regards to the applicability of Phase 1 data in healthy volunteers to patients with IgAN, Dr. Barratt added, "It's not that the Gd-IgA1 is subtly different, it's the same in both (healthy volunteers and patients with IgAN), but in patients, they just have an excess quantity. And so, what I believe is that because you're seeing a suppressed Gd-IgA1 in healthy subjects you are going to see the same in patients with IgA nephropathy, and indeed that's what some of the drugs targeting BAFF and APRIL have shown. They presented data in their healthy volunteer population that was precisely replicated when they went in to patients." BHV-1400 fundamentally differentiates from alternative approaches by virtue of its precision. While agents targeting the glucocorticoid receptors may have steroid-like side effects, those targeting complement require vaccination for encapsulated bacterial infections, and B-cell-directing therapies cause reductions in all isotypes of immunoglobulin, potentially increasing long-term infection risk. Based upon the rapid and deep reductions of Gd-IgA1 observed with SC dosing of BHV-1400, Biohaven plans to study BHV-1400 in patients with IgAN and initiate pivotal trials in 2026 using UPCR surrogate endpoint via the accelerated approval pathway. At its R&D Day, Biohaven also released new positive data from its completing Phase 1 study of its leading MoDE degrader, BHV-1300, that targets IgG for removal. In the Phase 1 multiple-dose study, SC administered BHV-1300 achieved IgG reductions up to 87%. Median maximum reductions of 83% were achieved within 18 days (Figure 2). Biohaven recently reported the 1000 mg weekly dose achieved rapid, deep and sustained reductions in total IgG of up to 84%, with a median reduction of 80% by Week 4 (Figure 2). Reductions at all doses occurred within hours of administration, were progressive, and effects were durable between dosing intervals. The range of IgG lowering enabled by different dose levels of BHV-1300 offers tunability and flexibility in dosing paradigm, with higher doses planned for management of acute conditions, and lower, less frequent dosing planned for the management of chronic disease. BHV-1300 has been safe and well-tolerated in subcutaneous doses up to 2000 mg with no clinically significant increases in ALT, AST, or bilirubin, no clinically significant reductions in albumin, and no clinically significant increases in cholesterol over the four-week dosing period relative to placebo. There were no clinically significant reductions in IgG3, IgA, IgE, or IgM relative to baseline. Most AEs were mild and self-resolving, and there were no serious or severe AEs. BHV-1300 is a potential first-in-class novel small molecule MoDE degrader in development for the treatment of IgG-mediated diseases, such as Graves' Disease. It is designed for self-administration via an easy-to-use and patient-friendly autoinjector. Biohaven plans to study BHV-1300 in patients with Graves' Disease and initiate a pivotal trial in 2H 2025. Tova Gardin, MD, MPP, Chief Translational Officer at Biohaven, commented, "Our lead MoDE and TRAP degraders, BHV-1300 and BHV-1400, deliver on the promise of ground-breaking chemistry, demonstrating unrivaled selectivity, and profound depletion of potentially disease-causing proteins. With the selectivity of the platform and the initial profile observed in Phase 1, we aim to bring precision immunology to patients with safe and effective treatments that target the core of disease biology. We are incredibly proud of our innovative, agile, and dynamic team that has catalyzed a first of its kind extracellular degrader technology from bench to the clinic. Driven by patient need and leading-edge, mechanistically precise science, Biohaven remains focused on delivering the promise of precision therapies to patients with immune-mediated disease." About BHV-1400BHV-1400 is a potential first-in-class Gd-IgA1 TRAP degrader, rationally designed to leverage the body's natural hepatic clearance mechanisms to selectively target and remove Gd-IgA1, the underlying cause of the IgA nephropathy and IgA vasculitis. BHV-1400 spares IgG, IgA, IgE, and IgM to preserve patient immune protection against bacteria, viruses and parasites. The results of the ongoing Phase 1 study confirm that BHV-1400 produces deep reductions in Gd-IgA1 within hours, is selective, sparing other immunoglobulins, is tunable, and is safe and well-tolerated. About BHV-1300BHV-1300 is a small molecule and potential first-in-class extracellular IgG degrader, rationally designed to leverage the body's natural hepatic clearance mechanisms to selectively target and remove IgG1, IgG2, and IgG4, the underlying cause of many immune-mediated diseases. BHV-1300 spares IgG3 to preserve patient immune protection against bacteria, viruses and parasites. The results of ongoing Phase 1 study confirm that BHV-1300 produces deep reductions in total IgG, is selective, sparing IgG3, is tunable, and is safe and well-tolerated. About BiohavenBiohaven is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. Biohaven is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms. Biohaven's extensive clinical and preclinical programs include Kv7 ion channel modulation for epilepsy and mood disorders; MoDE™ and TRAP™ extracellular protein degradation for immunological diseases; TRPM3 antagonism for migraine and neuropathic pain; TYK2/JAK1 inhibition for neuroinflammatory disorders; glutamate modulation for OCD and SCA; myostatin inhibition for neuromuscular and metabolic diseases, including SMA and obesity; antibody recruiting bispecific molecules; and antibody drug conjugates for cancer. For more information, visit Forward-looking Statements This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including "continue", "plan", "will", "believe", "may", "expect", "potential first-in-class", "potentially", "groundbreaking" and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements, including statements regarding the future development, timing and potential marketing approval and commercialization of development candidates, are not guarantees of future performance or results and involve substantial risks and uncertainties. Actual results, developments and events may differ materially from those in the forward-looking statements as a result of various factors including: the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials, including the studies of BHV-1300 and BHV-1400; the timing of planned interactions and filings with the FDA; the timing and outcome of expected regulatory filings; complying with applicable US regulatory requirements; the potential commercialization of Biohaven's product candidates; and the effectiveness and safety of Biohaven's product candidates. Additional important factors to be considered in connection with forward-looking statements are described in Biohaven's filings with the Securities and Exchange Commission, including within the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". The forward-looking statements are made as of the date of this news release, and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. MoDE and TRAP are trademarks of Biohaven Therapeutics Ltd. Investor Contact:Jennifer PorcelliVice President, Investor (201) 248-0741 Media Contact:Mike BeyerSam Brown (312) 961-2502 View original content to download multimedia: SOURCE Biohaven Ltd. Sign in to access your portfolio
Yahoo
3 days ago
- Business
- Yahoo
Biohaven Presents Oncology Program Updates and Preliminary Clinical Data Showcasing Innovative Trop2 and FGFR3 Antibody Drug Conjugates (ADCs) Incorporating Novel TopoIx Payload with Potential to Treat a Wide Variety of Tumors
BHV-1510, a highly differentiated Trop2 ADC incorporating the proprietary TopoIx payload, demonstrates early clinical activity and favorable safety profile in Phase 1 study as a monotherapy and in combination with Regeneron's anti-PD-1 cemiplimab. Tumor reduction was observed in the first 6 out of 6 patients treated with BHV-1510 plus cemiplimab including confirmed partial responses First patient dosed with Biohaven's novel, first-in-class FGFR3 directed TopoIx ADC, BHV-1530 Promising progress in the clinic demonstrates potential of Biohaven's innovative, next-generation ADC platform and TopoIx payload, with additional collaboration programs with Merus and GeneQuantum advancing preclinically. NEW HAVEN, Conn., May 28, 2025 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) (Biohaven), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today provided an update and preliminary clinical data from its oncology development programs at Biohaven's 2025 R&D Day, held concurrently with the Yale Innovation Summit in New Haven, Connecticut. The presentation slides from Biohaven's R&D day for Oncology and its other platforms will be available on the Events and Presentations page of the Biohaven website just prior to their presentations. Biohaven reported that its novel next-generation trophoblast cell surface antigen 2 (Trop2) directed antibody drug conjugate (ADC), BHV-1510, demonstrated encouraging preliminary clinical activity both as a monotherapy and in combination with Regeneron's anti-PD-1 antibody cemiplimab. Early clinical data is consistent with BHV-1510's preclinical profile showing high ADC stability, differentiated safety and efficacy, immunogenic cell death, and anti-PD-1 synergism. Monotherapy tumor reductions including partial responses have been seen in patients failing standard of care therapies. The combination of BHV-1510 and cemiplimab in the ongoing Phase 1 study shows encouraging anti-tumor activity, with tumor shrinkage in the first 6 out of 6 patients treated, including confirmed partial responses and in patients with brain metastasis (Figure 1). The majority of patients treated with the combination had failed prior anti–PD-1/PD-L1 therapies. BHV-1510 showed a favorable pharmacokinetic (PK) profile, with very low levels of free payload. As monotherapy, the main toxicity observed thus far in the Phase 1 study has been stomatitis, an expected on-target Trop2 class toxicity that has been manageable. Importantly, there were no cases of payload-associated interstitial lung disease (ILD), and low rates of gastrointestinal (e.g., diarrhea) and hematologic toxicities observed. The combination with cemiplimab was well tolerated with no dose limiting toxicity to date in initial cohorts. Nushmia Khokhar, M.D., Chief Medical Officer of Oncology at Biohaven, commented, "The early clinical data with BHV-1510 dosed in patients who failed standard of care treatment are highly encouraging, particularly the observed potential synergy with anti-PD-1 therapy. These findings, combined with the promising efficacy and tolerability profile of our novel TopoIx payload and stable linker technology, support the potential of BHV-1510 to advance into earlier lines of therapy for challenging tumor types." Biohaven also announced the first patient has been dosed in the Phase 1 study of BHV-1530, a potential first-in-class fibroblast growth factor receptor 3 (FGFR3)-directed ADC which utilizes the proprietary Topolx payload. BHV-1530 has potential in indications of cancers driven by FGFR3 alterations and/or upregulated FGFR3 protein expression, including urothelial cancers and other solid tumors (Figure 2). FGFR3 is a clinically validated target in oncology, with one small molecule inhibitor (erdafitinib) approved. There are no FGFR3 ADCs beyond BHV-1530 advanced in clinical testing. Michael Song, M.D., Ph.D., Principal Investigator and leading medical oncologist and hematologist at NEXT Oncology with over 22 years of experience in cancer patient care and cancer research, stated, "We are excited to partner with Biohaven and dose the first patient on this important study. This is an exciting, validated target with potential to extend therapeutic benefit to several FGFR3 driven tumors." Biohaven is also advancing a portfolio of innovative technologies to modernize next-generation ADCs through strategic collaborations with Merus and GeneQuantum (Figure 3). The preclinical programs leverage Biohaven's differentiated ADC platform directed against undisclosed novel validated and emerging high-value targets, and incorporating the TopoIx payload that preclinically demonstrated immunogenic cell death and synergistic efficacy with PD-1/PD-L1 checkpoint inhibitors. Brian Lestini, M.D., Ph.D., President of Oncology at Biohaven, commented, 'We are excited to be in the clinic with two innovative ADCs and to share the early clinical experience with the first of our two programs, demonstrating the potential of our oncology portfolio to deliver a wide range of optimized, next-generation ADCs. The early clinical data from the Trop2 ADC, BHV-1510, shows the predicted profile and potential of the proprietary TopoIx payload as seen preclinically, and supports broad investigation of ADCs incorporating TopoIx and highly stable linker technologies. Similarly, initiation of the first-in-human study of BHV-1530, an FGFR3 directed ADC, demonstrates the versatility of our approach to generate novel drugs with the potential to address a wide variety of unmet needs in oncology. Together with our collaborations with Merus and GeneQuantum as well as licensed conjugation technology from Yale University, Biohaven's platform has the potential to generate multiple differentiated mono- and bispecific ADC therapies with greater potency and selectivity over currently available ADC approaches." About BiohavenBiohaven is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. Biohaven is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms. Biohaven's extensive clinical and preclinical programs include Kv7 ion channel modulation for epilepsy and mood disorders; MoDE™ and TRAP™ extracellular protein degradation for immunological diseases; TRPM3 antagonism for migraine and neuropathic pain; TYK2/JAK1 inhibition for neuroinflammatory disorders; glutamate modulation for OCD and SCA; myostatin inhibition for neuromuscular and metabolic diseases, including SMA and obesity; antibody recruiting bispecific molecules; and antibody drug conjugates for cancer. For more information, visit Forward-looking StatementsThis news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected timing and amounts of funding under the NPA. The use of certain words, including "continue", "plan", "will", "believe", "may", "expect", "anticipate" and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements, including statements regarding the future development, timing and potential marketing approval and commercialization of development candidates, are not guarantees of future performance or results and involve substantial risks and uncertainties. Actual results, developments and events may differ materially from those in the forward-looking statements as a result of various factors including: the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials, including the combination of BHV-1510 and cemiplimab in the ongoing Phase 1 study; the timing of planned interactions and filings with the FDA; the timing and outcome of expected regulatory filings; complying with applicable U.S. regulatory requirements; the potential commercialization of Biohaven's product candidates and the expected timing thereof; the potential for Biohaven's product candidates to be successful therapies; and the effectiveness and safety of Biohaven's product candidates, including the safety profile of BHV-1510. Additional important factors to be considered in connection with forward-looking statements are described in Biohaven's filings with the Securities and Exchange Commission, including within the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". The forward-looking statements are made as of the date of this news release, and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Investor Contact:Jennifer PorcelliVice President, Investor (201) 248-0741 Media Contact:Mike BeyerSam Brown (312) 961-2502 View original content to download multimedia: SOURCE Biohaven Ltd.
Yahoo
4 days ago
- General
- Yahoo
Austin doctor studying a new kind of medication for major depressive disorder
Austin psychiatrist Dr. Donald J. Garcia is enrolling patients in a study on a new kind of medication for major depressive disorder. While drug companies have created many medications that help increase serotonin, that neurotransmitter chemical that is our natural mood stabilizer in the brain, only about 60% to 70% of patients will respond to those medications, Garcia said. The major depressive disorder medication, BHV-7000, is different than those that focus on serotonin because it focuses on potassium channels, which help regulate the activity of neurons in the brain. The channels "could help calm the brain and get it back to a normal state," Garcia said. "This is an interesting hypothesis." Garcia and his company Austin Clinical Trial Partners are enrolling up to 306 people ages 18 to 75 in a trial to study the drug, which is made by the biopharmaceutical company Biohaven. For the trial, Garcia is looking for people who are having a major depressive disorder episode lasting two months up to 24 months. They must stop taking their depression medication at least two weeks prior to enrolling in the study, and cannot be having suicidal thoughts. Interested participants will receive a physical exam and testing to make sure they are medically stable before beginning the study. Garcia noted that having major depressive disorder doesn't just mean you are depressed, which is a description of a mood state. It's "depression plus other symptoms that become a clinical syndrome," he said. Those symptoms may include insomnia, a loss of interest in things you used to love, or simply not taking pleasure in daily life. They are constant, lasting for longer than just one or two days, and can creep up on you, Garcia said. Can a magnet help my mental health? How transcranial magnetic stimulation works in Austin. Half of the people in the study will receive the BHV-7000 medication and half will receive a placebo. No one will know which group they have been assigned to. Enrollees will continue taking the medication or the placebo for six weeks. After that part of the study concludes, they may opt to continue with the study and would be guaranteed to receive the medication for 52 weeks. Garcia said he feels better knowing that he can offer the medication to all participants after the initial study period ends. While in the study, participants will receive free psychiatric care. Such clinical trials "bring us closer to the understanding of how depression might come about," Garcia said. "It might be caused by a number of different mechanisms or issues." Dell Medical School clinic at UT Austin joins global bipolar study for treatments To find out more about the study and if they qualify, people can visit or This article originally appeared on Austin American-Statesman: Austin doctor studying major depressive disorder medication
Yahoo
16-05-2025
- Business
- Yahoo
Why Biohaven Stock Dove by Nearly 20% on Thursday
The company announced some discouraging news from a major regulatory body. It will have to wait longer than expected on an application for a very promising developmental drug. 10 stocks we like better than Biohaven › Volatile biotech stock Biohaven (NYSE: BHVN) is prone to sharp movements both up and down. On Thursday, it had one of its down days, with its share price eroding by almost 20% on a development with a top regulator. That was on a day when stocks generally did well, as indicated by the S&P 500 (SNPINDEX: ^GSPC) landing in positive territory with a 0.4% rise. After market close on Wednesday, Biohaven divulged that the U.S. Food and Drug Administration's (FDA) Division of Neurology 1 is extending the due date for its decision on a very promising pipeline drug developed by the company. Specifically, the FDA unit is extending the Prescription Drug User Fee Act (PDUFA) date for Biohaven's troriluzole, a treatment that targets brain disorder spinocerebellar ataxia (SCA), by three months. The biotech has formally submitted troriluzole under the FDA's New Drug Application (NDA) regime, and now expects a decision from the regulator to come in the fourth calendar quarter of this year. According to the company, the FDA said it required the extra time to conduct a full review of recent Biohaven submissions to the regulator's information requests. The FDA division also told the company that it aims to hold an advisory committee meeting to discuss the troriluzole application, but no date has yet been set for this. Many investors consider Biohaven to boast excellent potential with troriluzole, as it targets a rare brain disorder that currently has no treatment. It has been granted fast-track, priority review, and orphan drug designation (ODD) by the FDA, so initially it seemed as if a decision on approval would come soon. It's always disappointing when there's a delay, but until we know more about the regulator's concerns, it's hard to gauge the ultimate future of troriluzole. Much will depend on the FDA's moves in the coming months. Before you buy stock in Biohaven, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Biohaven wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $620,719!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $829,511!* Now, it's worth noting Stock Advisor's total average return is 959% — a market-crushing outperformance compared to 170% for the S&P 500. Don't miss out on the latest top 10 list, available when you join . See the 10 stocks » *Stock Advisor returns as of May 12, 2025 Eric Volkman has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Why Biohaven Stock Dove by Nearly 20% on Thursday was originally published by The Motley Fool
