This section highlights FDA-related milestones and regulatory updates for drugs developed by Biohaven (BHVN).
Over the past two years, Biohaven has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
BHV-1300, BHV-1400, BHV-1510, BHV-2100, BHV4157-206-RWE, BHV-7000, and BHV-8000. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
BHV-1300 - FDA Regulatory Timeline and Events
BHV-1300 is a drug developed by Biohaven for the following indication: For the potential treatment of autoimmune disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BHV-1300
- Announced Date:
- March 3, 2025
- Indication:
- For the potential treatment of autoimmune disease.
Announcement
Biohaven Ltd. highlighted the success of BHV-1300, its potential first-in-class IgG1,2,4 selective degrader, in achieving rapid and deep reductions in total IgG, advancing a novel and transformative MoDE platform molecule for the potential treatment of autoimmune disease.
AI Summary
Biohaven Ltd. has highlighted the success of its BHV-1300 in a recent Phase 1 study. This potential first-in-class small molecule is an IgG degrader that selectively targets IgG1, IgG2, and IgG4 while sparing IgG3, which helps maintain immune protection. The study showed that weekly subcutaneous doses of 1000 mg of BHV-1300 led to rapid and deep reductions in total IgG levels—up to an 84% drop, with a median reduction of 80%—with effects seen within hours of dosing. This performance supports the promise of Biohaven’s transformative MoDE platform, which is designed to deliver tunable treatment options for autoimmune diseases. The favorable safety and tolerability profile of BHV-1300 also adds to its potential as a revolutionary option for treating conditions such as Graves’ disease. Future studies will further explore its optimal dosing and long-term effects.
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BHV-1400 - FDA Regulatory Timeline and Events
BHV-1400 is a drug developed by Biohaven for the following indication: For IgA nephropathy.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BHV-1400
- Announced Date:
- May 28, 2025
- Indication:
- For IgA nephropathy
Announcement
Biohaven Ltd. 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.
AI Summary
Biohaven Ltd highlighted strong early results at its 2025 R&D Day, held alongside the Yale Innovation Summit in New Haven, Connecticut. The company presented its first MoDE™ and TRAP™ degraders as achieving key pharmacodynamic targets. Notably, the TRAP degrader BHV‑1400 delivered rapid, deep, and sustained reductions in galactose-deficient IgA1—up to an 81% decrease from baseline—demonstrating precise removal of the pathogenic antibody while sparing healthy immunoglobulins.
Building on these promising findings, Biohaven announced plans to initiate pivotal clinical trials in Graves’ Disease and IgA nephropathy. The trial for Graves’ Disease is slated for the second half of 2025, while the IgA nephropathy trial is expected to start in the first half of 2026. These endeavors underscore the company’s commitment to precision immunology and advancing targeted therapies for immune-mediated diseases.
Read Announcement- Drug:
- BHV-1400
- Announced Date:
- January 13, 2025
- Indication:
- For IgA nephropathy
Announcement
Biohaven Ltd. today highlighted broad portfolio progress at the 43rd Annual J.P. Morgan Healthcare Conference, including positive Phase 1 data for BHV-1400, its highly differentiated investigational therapeutic for IgA nephropathy.
AI Summary
Biohaven Ltd. presented promising Phase 1 results for BHV‑1400, its innovative therapeutic for IgA nephropathy, at the 43rd Annual J.P. Morgan Healthcare Conference. BHV‑1400, a second-generation TRAP™ degrader, quickly reduced the problematic antibody Gd‑IgA1—responsible for IgA nephropathy—by 60% within four hours and over 70% within eight hours after a single 125mg dose. Importantly, the drug selectively lowered only the disease-causing antibody while sparing normal immunoglobulins, indicating a more precise approach than existing therapies.
The treatment has been safe and well-tolerated so far, with no significant changes in white blood cell counts, immunoglobulins, liver tests, or cholesterol levels. These encouraging results suggest that BHV‑1400 could offer effective disease control with fewer risks, and a pivotal trial using an accelerated regulatory pathway is planned once Phase 1 is complete.
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BHV-1510 - FDA Regulatory Timeline and Events
BHV-1510 is a drug developed by Biohaven for the following indication: In Advanced or Metastatic Epithelial Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BHV-1510
- Announced Date:
- May 28, 2025
- Indication:
- In Advanced or Metastatic Epithelial Tumors
Announcement
Biohaven Ltd 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.
AI Summary
At Biohaven’s 2025 R&D Day, held during the Yale Innovation Summit in New Haven, Connecticut, the company provided an update on its oncology development programs. Biohaven shared preliminary clinical data for its Trop2-directed antibody drug conjugate (ADC) BHV-1510, which uses the proprietary TopoIx payload. Early results showed encouraging anti-tumor activity, with tumor shrinkage observed in all initial patients treated with BHV-1510 combined with Regeneron’s anti-PD-1 antibody, cemiplimab, including confirmed partial responses in those who had failed prior therapies.
The data highlights the potential of Biohaven’s next-generation ADC platform to address unmet needs in oncology. Additionally, Biohaven announced the dosing of the first patient in its Phase 1 study for BHV-1530, a novel FGFR3-directed ADC, further supporting the company’s innovative approach to developing new cancer treatments.
Read Announcement- Drug:
- BHV-1510
- Announced Date:
- May 29, 2024
- Indication:
- In Advanced or Metastatic Epithelial Tumors
Announcement
Biohaven Ltd announced the first patient has been dosed in a first-in-human Phase 1/2 study of BHV-1510, a highly differentiated Trophoblast Cell Surface Antigen-2 (Trop-2) directed Antibody Drug Conjugate (ADC), and the lead ADC program to advance into clinical trials in Biohaven's growing oncology pipeline.
AI Summary
Biohaven Ltd announced that the first patient has been dosed in a Phase 1/2 trial of BHV-1510, a novel antibody drug conjugate (ADC) targeting Trop-2—a protein expressed on many cancer cells. This first-in-human study marks the entry of Biohaven’s lead ADC into their growing oncology pipeline. The trial is testing BHV-1510 both as a standalone treatment and in combination with Regeneron’s anti-PD-1 therapy, Libtayo®, with the goal of finding a safer and more effective option for patients with advanced or metastatic epithelial tumors. BHV-1510 has shown promising preclinical results, suggesting it may offer broader therapeutic benefits and improved safety margins compared to similar treatments. This advancement brings Biohaven one step closer to providing new treatment choices for cancer patients with limited options.
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BHV-2100 - FDA Regulatory Timeline and Events
BHV-2100 is a drug developed by Biohaven for the following indication: In the acute treatment of migraine.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BHV-2100
- Announced Date:
- September 30, 2024
- Indication:
- In the acute treatment of migraine.
Announcement
Biohaven Ltd announced that that it has initiated a pivotal Phase 2 study of the potential first-in-class, orally administered TRPM3 antagonist, BHV-2100, in the acute treatment of migraine.
AI Summary
Biohaven Ltd. has started a pivotal Phase 2 clinical trial to evaluate BHV-2100, a potential first-in-class, orally administered TRPM3 antagonist, for the acute treatment of migraine. The study will compare two doses (75 mg and 150 mg) of BHV-2100 with a placebo in about 575 patients at 60 sites in the United States. The trial’s goal is to determine the drug’s effectiveness by measuring pain freedom and relief from the most bothersome migraine symptoms two hours after taking the treatment.
BHV-2100 is designed as a non-opioid and non-sedating medication, with promising early Phase 1 results showing good safety, rapid absorption, and sustained drug levels. This study highlights Biohaven’s commitment to developing innovative therapies for migraine, addressing the unmet needs of patients who do not respond well to current treatment options.
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BHV4157-206-RWE - FDA Regulatory Timeline and Events
BHV4157-206-RWE is a drug developed by Biohaven for the following indication: To assess the effectiveness of troriluzole in Spinocerebellar Ataxia.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BHV4157-206-RWE
- Announced Date:
- September 20, 2024
- Indication:
- To assess the effectiveness of troriluzole in Spinocerebellar Ataxia.
Announcement
Biohaven Ltd. announced that it will host a conference call to discuss topline data from Study BHV4157-206-RWE (NCT06529146), a study designed in discussion with the US Food and Drug Administration (FDA), to assess the effectiveness of troriluzole in Spinocerebellar Ataxia.
AI Summary
Biohaven Ltd. has announced a conference call on Monday, September 23, 2024, at 8:30 a.m. Eastern Time to discuss topline data from Study BHV4157-206-RWE. This study, designed in discussion with the US Food and Drug Administration (FDA), focuses on evaluating the effectiveness of troriluzole for treating Spinocerebellar Ataxia. Troriluzole is a new chemical entity that works by reducing the levels of glutamate in the brain, a neurotransmitter involved in nerve cell communication. The company will share the initial findings during the webcast, which can be accessed through their investor relations website. This update comes as part of Biohaven’s ongoing efforts to develop innovative treatments in neuroscience and related fields, aiming to improve the quality of life for individuals affected by Spinocerebellar Ataxia.
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BHV-7000 - FDA Regulatory Timeline and Events
BHV-7000 is a drug developed by Biohaven for the following indication: For the treatment of epilepsy and mood disorders.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BHV-7000
- Announced Date:
- December 6, 2024
- Indication:
- For the treatment of epilepsy and mood disorders
Announcement
Biohaven Ltd. announced today that it is presenting expanded safety data from BHV-7000 multiple-dose studies at the American Epilepsy Society (AES) 2024 Annual Meeting, taking place December 6-10, 2024, in Los Angeles, California.
AI Summary
Biohaven Ltd. announced that it will present expanded safety data from its BHV-7000 multiple-dose studies at the American Epilepsy Society (AES) 2024 Annual Meeting in Los Angeles, California, from December 6-10, 2024. The data focuses on the once-daily extended-release formulation currently under evaluation in ongoing Phase 2 and 3 clinical trials. In the Phase 1 multiple ascending dose studies, BHV-7000 demonstrated excellent tolerability at all doses, without the common central nervous system adverse effects—such as somnolence and cognitive or mood disturbances—that are typically seen with other anti-seizure medications. These promising results support continued development of BHV-7000 as a potential new treatment option for epilepsy that could address unmet patient needs by reducing the side effects that often impact quality of life.
Read Announcement- Drug:
- BHV-7000
- Announced Date:
- April 13, 2024
- Indication:
- For the treatment of epilepsy and mood disorders
Announcement
Biohaven Ltd. announced that 20 abstracts, including 8 oral presentations and 12 posters, will be featured this weekend starting April 13th at the 2024 American Academy of Neurology (AAN) Annual Meeting, taking place in Denver, Colorado.
AI Summary
Biohaven Ltd. announced that 20 abstracts, including 8 oral presentations and 12 posters, will be featured at the 2024 American Academy of Neurology (AAN) Annual Meeting in Denver, Colorado, starting April 13. The presentations will showcase Biohaven’s innovative approaches in neuroscience, highlighting their advancements in fields such as Kv7 ion channel modulation, molecular degraders of extracellular proteins (MoDEs), and TRPM3 antagonism. These sessions underline Biohaven’s commitment to developing novel treatments for neurological disorders. By targeting unique mechanisms of action, the company aims to address significant unmet needs in conditions like epilepsy, pain, and Parkinson’s disease. This impressive lineup not only emphasizes the company’s leadership in clinical and preclinical research but also reinforces its ongoing efforts to bring new therapeutic options to patients suffering from various neurological diseases.
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BHV-8000 - FDA Regulatory Timeline and Events
BHV-8000 is a drug developed by Biohaven for the following indication: For Neuroinflammatory and Neurodegenerative Diseases.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BHV-8000
- Announced Date:
- May 29, 2025
- Indication:
- For Neuroinflammatory and Neurodegenerative Diseases
Announcement
Biohaven Ltd that it has initiated a global Phase 2/3 study of the first-in-clinic, orally-administered, brain-penetrant, and highly selective TYK2/JAK1 inhibitor, BHV-8000, for the treatment of early Parkinson's disease (PD).
AI Summary
Biohaven Ltd. has launched a global Phase 2/3 study for BHV-8000, the first-in-clinic, orally administered drug designed to treat early Parkinson’s disease. BHV-8000 is a unique, brain-penetrant inhibitor that selectively targets TYK2 and JAK1 enzymes, which are linked to neuroinflammation and immune dysregulation in Parkinson’s. The study will evaluate the drug’s safety and effectiveness using a randomized, double-blind, placebo-controlled design at approximately 185 sites in 13 countries, including the United States and several European nations. Two doses, 10 mg and 20 mg, will be compared against a placebo. The trial’s primary endpoint is based on a significant change in the MDS-UPDRS Part II score, an endpoint accepted by the FDA to support potential registration. This innovative study represents an important step toward providing a disease-modifying therapy for Parkinson’s patients.
Read Announcement- Drug:
- BHV-8000
- Announced Date:
- April 5, 2025
- Indication:
- For Neuroinflammatory and Neurodegenerative Diseases
Announcement
Biohaven announced that it will present 13 abstracts at the 2025 American Academy of Neurology (AAN) Annual Meeting, taking place from April 5 to April 9, 2025 in San Diego, California.
AI Summary
Biohaven Ltd. announced that it will present 13 abstracts at the 2025 American Academy of Neurology (AAN) Annual Meeting in San Diego, California, from April 5 to April 9, 2025. The presentations include 3 oral presentations and 10 poster sessions that highlight the company’s progress in neuroscience. These abstracts cover early to late-stage research in key areas such as TYK2/JAK1 inhibition, TRPM3 antagonism, ion channel modulation, and other innovative treatments for neurological disorders.
The company’s work focuses on developing therapies for conditions like Parkinson’s disease, migraine, epilepsy, and more. By showcasing its data at the AAN Annual Meeting, Biohaven emphasizes its commitment to advancing potential first-in-class treatments for debilitating neurological disorders with few or no current treatment options. The abstracts will soon be available online for further details.
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Troriluzole (SCA) - FDA Regulatory Timeline and Events
Troriluzole (SCA) is a drug developed by Biohaven for the following indication: Spinocerebellar Ataxia (SCA).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Troriluzole (SCA)
- Announced Date:
- May 14, 2025
- Estimated Event Date Range:
- October 1, 2025 - December 31, 2025
- Target Action Date:
- Q4 - 2025
- Indication:
- Spinocerebellar Ataxia (SCA)
Announcement
Biohaven Ltd. announced that The FDA's decision regarding the NDA is now expected in 4Q 2025.
AI Summary
Biohaven Ltd. announced an update on its ongoing review process for the new drug application (NDA) for troriluzole, a treatment for spinocerebellar ataxia (SCA), a rare and severe neurodegenerative disease. The FDA has extended the review period by three months to allow a complete evaluation of Biohaven’s latest submissions, and the decision on the NDA is now expected in the fourth quarter of 2025.
The agency also plans to hold an advisory committee meeting to further discuss the application, though no meeting date has yet been set. Importantly, the FDA did not raise any new concerns in its recent letter. Biohaven remains hopeful that this extra time will help provide a clearer picture of the treatment’s potential to benefit patients and families affected by SCA.
Read Announcement- Drug:
- Troriluzole (SCA)
- Announced Date:
- May 14, 2025
- Indication:
- Spinocerebellar Ataxia (SCA)
Announcement
Biohaven Ltd 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 (NDA) 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.
AI Summary
Biohaven Ltd announced that the FDA’s Division of Neurology 1 has extended the PDUFA date for the troriluzole new drug application by three months. This extension is to allow the FDA extra time to conduct a full review of Biohaven’s recent submissions related to information requests. The delay means that the decision on the NDA, which seeks approval for the treatment of spinocerebellar ataxia (SCA), is now expected in the fourth quarter of 2025.
The FDA also mentioned plans to hold an advisory committee meeting to discuss the application, though no date has been set. Importantly, the FDA did not raise any new concerns in its communication, indicating that the focus remains on ensuring a thorough review of Biohaven’s latest submissions regarding this potential treatment for the rare, genetic neurodegenerative disease.
Read Announcement- Drug:
- Troriluzole (SCA)
- Announced Date:
- February 11, 2025
- Indication:
- Spinocerebellar Ataxia (SCA)
Announcement
Biohaven Ltd. announced that the US Food and Drug Administration (FDA) has accepted for review the Company's New Drug Application (NDA) for troriluzole for the treatment of adult patients with spinocerebellar ataxia (SCA) and has granted Priority Review.
AI Summary
Biohaven Ltd. announced that the FDA has accepted for review its New Drug Application (NDA) for troriluzole, a drug intended to treat adult patients with spinocerebellar ataxia (SCA). The FDA granted Priority Review, a designation reserved for treatments that show significant improvement over available options or offer a new treatment for conditions that have no approved therapies. If approved, troriluzole would be the first FDA-approved treatment for SCA, a life-threatening neurodegenerative disease with no current treatment.
Troriluzole has shown promising results by slowing disease progression by 50-70% over three years in a real-world study. The FDA is expected to review the application and make a decision within six months, possibly leading to commercialization of the drug in the US in 2025. This review marks a key step forward for both patients and the SCA community.
Read Announcement- Drug:
- Troriluzole (SCA)
- Announced Date:
- December 16, 2024
- Indication:
- Spinocerebellar Ataxia (SCA)
Announcement
Biohaven Ltd. today highlighted the achievement of several clinical and regulatory milestones across its proprietary Molecular Degrader of Extracellular Proteins (MoDE™) platform as well as its glutamate modulation and ion channel programs.
AI Summary
Biohaven Ltd. highlighted significant progress in its clinical and regulatory programs, notably advancing its proprietary Molecular Degrader of Extracellular Proteins (MoDE™) platform alongside its glutamate modulation and ion channel initiatives. In its Phase 1 study, the subcutaneous formulation of BHV-1300 delivered rapid, deep lowering of targeted IgG levels—achieving reductions of over 60% at the lowest dose—while showing sustained pharmacodynamic effects over four weeks. The treatment was safe and well tolerated, with mild adverse events and notably less inter-patient variability compared to its previous intravenous formulation. Additionally, the design of BHV-1300 selectively spares IgG3, preserving healthy immune function. These results not only validate the precision and potential of the MoDE technology in treating autoantibody-driven diseases but also underscore Biohaven’s commitment to pioneering innovative therapies across multiple clinical fronts.
Read Announcement- Drug:
- Troriluzole (SCA)
- Announced Date:
- September 23, 2024
- Indication:
- Spinocerebellar Ataxia (SCA)
Announcement
Biohaven Ltd. announced positive topline results from pivotal Study BHV4157-206-RWE (NCT06529146) demonstrating the efficacy of troriluzole on the mean change from baseline in the f-SARA after 3 years of treatment.
AI Summary
Biohaven Ltd. announced positive topline results from its pivotal Study BHV4157-206-RWE (NCT06529146) evaluating the effects of troriluzole in patients with spinocerebellar ataxia (SCA). The trial showed that once-daily oral dosing of 200 mg troriluzole significantly improved the mean change from baseline in the modified functional Scale for the Assessment and Rating of Ataxia (f-SARA) after 3 years of treatment. Statistically significant benefits were already observed at 1 and 2 years, and the overall data indicate a robust slowing of disease progression by 50-70%, translating to a delay of 1.5-2.2 years.
These promising results demonstrate the efficacy of troriluzole as a potential treatment for SCA, offering new hope for patients suffering from this debilitating, progressive disorder with no currently approved therapies.
Read Announcement
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