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Biohaven begins first human trial of brain-penetrant drug BHV-8100

Mon, 01 Jun 2026 07:31:24 -0400

Biohaven Ltd. (NYSE: BHVN) announced it has initiated first-in-human dosing for BHV-8100, an oral drug designed to modulate the PKM2 enzyme for treating metabolic and immune disorders affecting the central nervous system and other organs.

The Phase 1 study is evaluating the safety, tolerability and pharmacokinetics of BHV-8100 in healthy participants. Preliminary data from the ongoing trial shows the drug achieves projected therapeutic levels and supports once-daily dosing, according to the company's press release.

BHV-8100 targets pyruvate kinase M2, an enzyme involved in cellular energy production. The drug is designed to cross the blood-brain barrier and restore metabolic function in energy-demanding tissues

Biohaven begins first human trial of brain-penetrant drug BHV-8100

Mon, 01 Jun 2026 07:31:24 -0400

BHV-8100 targets pyruvate kinase M2, an enzyme involved in cellular energy production. The drug is designed to cross the blood-brain barrier and restore metabolic function in energy-demanding tissues

Biohaven Reports First-in-Human Dosing of Oral PKM2 Modulator, BHV-8100, Targeting Metabolic Restoration and Immunomodulation

Mon, 01 Jun 2026 07:30:00 -0400

BHV-8100 is an orally administered, brain-penetrant PKM2 modulator; a novel therapeutic class addressing the bioenergetic and immunometabolic basis of systemic and central nervous system disorders
First-in-human study initiated with dose escalation ongoing; preliminary data in healthy participants demonstrates favorable pharmacokinetics supporting convenient, once-daily dosing and well a tolerated profile at projected therapeutic exposures
Penetrates blood-brain barrier and reverses metabolic dysfunction with 3-fold improvement in glucose utilization in human, whole brain model (Bexorg BrainEx platform, physiologically reactivated brains from human donors); preferential metabolic rescue in Alzheimer's disease donor brains vs controls
Exhibits robust beneficial effects across a spectrum of preclinical models

Biohaven Reports First-in-Human Dosing of Oral PKM2 Modulator, BHV-8100, Targeting Metabolic Restoration and Immunomodulation

Mon, 01 Jun 2026 07:30:00 -0400

BHV-8100 is an orally administered, brain-penetrant PKM2 modulator; a novel therapeutic class addressing the bioenergetic and immunometabolic basis of systemic and central nervous system disorders
First-in-human study initiated with dose escalation ongoing; preliminary data in healthy participants demonstrates favorable pharmacokinetics supporting convenient, once-daily dosing and well a tolerated profile at projected therapeutic exposures
Penetrates blood-brain barrier and reverses metabolic dysfunction with 3-fold improvement in glucose utilization in human, whole brain model (Bexorg BrainEx platform, physiologically reactivated brains from human donors); preferential metabolic rescue in Alzheimer's disease donor brains vs controls
Exhibits robust beneficial effects across a spectrum of preclinical models

Biohaven Reports First-in-Human Dosing of Oral PKM2 Modulator, BHV-8100, Targeting Metabolic Restoration and Immunomodulation

Mon, 01 Jun 2026 07:30:00 -0400

BHV-8100 is an orally administered, brain-penetrant PKM2 modulator; a novel therapeutic class addressing the bioenergetic and immunometabolic basis of systemic and central nervous system disorders
First-in-human study initiated with dose escalation ongoing; preliminary data in healthy participants demonstrates favorable pharmacokinetics supporting convenient, once-daily dosing and well a tolerated profile at projected therapeutic exposures
Penetrates blood-brain barrier and reverses metabolic dysfunction with 3-fold improvement in glucose utilization in human, whole brain model (Bexorg BrainEx platform, physiologically reactivated brains from human donors); preferential metabolic rescue in Alzheimer's disease donor brains vs controls
Exhibits robust beneficial effects across a spectrum of preclinical models

Biohaven Reports First-in-Human Dosing of Oral PKM2 Modulator, BHV-8100, Targeting Metabolic Restoration and Immunomodulation

Mon, 01 Jun 2026 07:30:00 -0400

BHV-8100 is an orally administered, brain-penetrant PKM2 modulator; a novel therapeutic class addressing the bioenergetic and immunometabolic basis of systemic and central nervous system disorders
First-in-human study initiated with dose escalation ongoing; preliminary data in healthy participants demonstrates favorable pharmacokinetics supporting convenient, once-daily dosing and well a tolerated profile at projected therapeutic exposures
Penetrates blood-brain barrier and reverses metabolic dysfunction with 3-fold improvement in glucose utilization in human, whole brain model (Bexorg BrainEx platform, physiologically reactivated brains from human donors); preferential metabolic rescue in Alzheimer's disease donor brains vs controls
Exhibits robust beneficial effects across a spectrum of preclinical models

Biohaven Reports First-in-Human Dosing of Oral PKM2 Modulator, BHV-8100, Targeting Metabolic Restoration and Immunomodulation

Mon, 01 Jun 2026 07:30:00 -0400

BHV-8100 is an orally administered, brain-penetrant PKM2 modulator; a novel therapeutic class addressing the bioenergetic and immunometabolic basis of systemic and central nervous system disorders
First-in-human study initiated with dose escalation ongoing; preliminary data in healthy participants demonstrates favorable pharmacokinetics supporting convenient, once-daily dosing and well a tolerated profile at projected therapeutic exposures
Penetrates blood-brain barrier and reverses metabolic dysfunction with 3-fold improvement in glucose utilization in human, whole brain model (Bexorg BrainEx platform, physiologically reactivated brains from human donors); preferential metabolic rescue in Alzheimer's disease donor brains vs controls
Exhibits robust beneficial effects across a spectrum of preclinical models

Biohaven Reports First-in-Human Dosing of Oral PKM2 Modulator, BHV-8100, Targeting Metabolic Restoration and Immunomodulation

Mon, 01 Jun 2026 07:30:00 -0400

BHV-8100 is an orally administered, brain-penetrant PKM2 modulator; a novel therapeutic class addressing the bioenergetic and immunometabolic basis of systemic and central nervous system disorders
First-in-human study initiated with dose escalation ongoing; preliminary data in healthy participants demonstrates favorable pharmacokinetics supporting convenient, once-daily dosing and well a tolerated profile at projected therapeutic exposures
Penetrates blood-brain barrier and reverses metabolic dysfunction with 3-fold improvement in glucose utilization in human, whole brain model (Bexorg BrainEx platform, physiologically reactivated brains from human donors); preferential metabolic rescue in Alzheimer's disease donor brains vs controls
Exhibits robust beneficial effects across a spectrum of preclinical models

Biohaven Reports First-in-Human Dosing of Oral PKM2 Modulator, BHV-8100, Targeting Metabolic Restoration and Immunomodulation

Mon, 01 Jun 2026 07:30:00 -0400

BHV-8100 is an orally administered, brain-penetrant PKM2 modulator; a novel therapeutic class addressing the bioenergetic and immunometabolic basis of systemic and central nervous system disorders
First-in-human study initiated with dose escalation ongoing; preliminary data in healthy participants demonstrates favorable pharmacokinetics supporting convenient, once-daily dosing and well a tolerated profile at projected therapeutic exposures
Penetrates blood-brain barrier and reverses metabolic dysfunction with 3-fold improvement in glucose utilization in human, whole brain model (Bexorg BrainEx platform, physiologically reactivated brains from human donors); preferential metabolic rescue in Alzheimer's disease donor brains vs controls
Exhibits robust beneficial effects across a spectrum of preclinical models

Biohaven Reports First-in-Human Dosing of Oral PKM2 Modulator, BHV-8100, Targeting Metabolic Restoration and Immunomodulation

Mon, 01 Jun 2026 07:30:00 -0400

BHV-8100 is an orally administered, brain-penetrant PKM2 modulator; a novel therapeutic class addressing the bioenergetic and immunometabolic basis of systemic and central nervous system disorders
First-in-human study initiated with dose escalation ongoing; preliminary data in healthy participants demonstrates favorable pharmacokinetics supporting convenient, once-daily dosing and well a tolerated profile at projected therapeutic exposures
Penetrates blood-brain barrier and reverses metabolic dysfunction with 3-fold improvement in glucose utilization in human, whole brain model (Bexorg BrainEx platform, physiologically reactivated brains from human donors); preferential metabolic rescue in Alzheimer's disease donor brains vs controls
Exhibits robust beneficial effects across a spectrum of preclinical models

Form 8-K Biohaven Ltd. For: May 26

Wed, 27 May 2026 17:14:00 -0400
si-local-file:///var/storage/secattach/20260527/26559102.html

Form 8-K Biohaven Ltd. For: May 26

Wed, 27 May 2026 17:14:00 -0400
si-local-file:///var/storage/secattach/20260527/26559102.html

Raymond James on Biohaven Pharma (BHVN) with shares up 7%: 'Promising Degrader Data Sets Ahead of R&D Day'

Wed, 27 May 2026 10:16:30 -0400

Raymond James analyst Chris Raymond reiterated a Strong Buy rating and $50.00 price target on Biohaven Pharma (NYSE: BHVN).
The analyst comments "Remain Strong Buy rated on BHVN shares following the announcement of positive preliminary data sets for degraders BHV-1300 and BHV-1400 in patients this morning ahead of today’s R&D Day. For ‘1300 in Graves disease, early data from three patients who were hyperthyroid at baseline in an ongoing P1b trial demonstrated >80% reduction in the TSHR-IgG1 autoantibodies which drive disease pathology by week 12, leading to normalization of T3 and T4 thyroid hormones. For ‘1400 in IgAN, early data from

Raymond James on Biohaven Pharma (BHVN) with shares up 7%: 'Promising Degrader Data Sets Ahead of R&D Day'

Wed, 27 May 2026 10:16:30 -0400

Raymond James analyst Chris Raymond reiterated a Strong Buy rating and $50.00 price target on Biohaven Pharma (NYSE: BHVN).
The analyst comments "Remain Strong Buy rated on BHVN shares following the announcement of positive preliminary data sets for degraders BHV-1300 and BHV-1400 in patients this morning ahead of today’s R&D Day. For ‘1300 in Graves disease, early data from three patients who were hyperthyroid at baseline in an ongoing P1b trial demonstrated >80% reduction in the TSHR-IgG1 autoantibodies which drive disease pathology by week 12, leading to normalization of T3 and T4 thyroid hormones. For ‘1400 in IgAN, early data from

Biohaven reports positive patient data for autoimmune disease drugs

Wed, 27 May 2026 07:31:00 -0400

Biohaven Ltd. (NYSE: BHVN) reported clinical data for two experimental drugs targeting autoimmune diseases, according to a company press release.
BHV-1300, being tested for Graves' disease, achieved mean reductions of more than 80% in pathogenic TSHR-IgG1 antibodies over 12 weeks in patients receiving 1000 mg subcutaneous weekly doses. Patients with elevated thyroid hormones experienced normalization of free T4 at a median of 3 weeks and free T3 at a median of 5 weeks after initial treatment.
BHV-1400, designed for IgA nephropathy treatment, demonstrated mean reductions of more than 60% in galactose-deficient IgA1 within 48 hours and 70% reductions within one month of

Biohaven reports positive patient data for autoimmune disease drugs

Wed, 27 May 2026 07:31:00 -0400

Biohaven Ltd. (NYSE: BHVN) reported clinical data for two experimental drugs targeting autoimmune diseases, according to a company press release.
BHV-1300, being tested for Graves' disease, achieved mean reductions of more than 80% in pathogenic TSHR-IgG1 antibodies over 12 weeks in patients receiving 1000 mg subcutaneous weekly doses. Patients with elevated thyroid hormones experienced normalization of free T4 at a median of 3 weeks and free T3 at a median of 5 weeks after initial treatment.
BHV-1400, designed for IgA nephropathy treatment, demonstrated mean reductions of more than 60% in galactose-deficient IgA1 within 48 hours and 70% reductions within one month of

Biohaven Reports Positive Clinical Biomarker and Patient Data: First MoDE and TRAP Extracellular Protein Degraders Achieve Deep, Rapid, Selective Lowering of Disease-Driving Antibodies in Graves' Dise

Wed, 27 May 2026 07:30:00 -0400

BHV-1300 demonstrated deep, rapid, and sustained lowering of pathogenic TSHR autoantibodies (TSHR-IgG1) in patients with Graves' hyperthyroidism receiving 1000 mg SC weekly, with mean reductions in TSHR-IgG1exceeding >80% over the 12-week study.
Participants with Graves' overt hyperthyroidism, confirmed by elevated baseline thyroid tests despite being treated with anti-thyroid drug therapy (ATD), experienced normalization of thyroid hormones within weeks; T4 normalization occurring at a median of 3 weeks and T3 at a median of 5 weeks after the first administration of BHV-1300.
These preliminary patient data from an ongoing Phase 1b study highlight deep lowering of TSHR-IgG1 with BHV-1300 as

Biohaven Reports Positive Clinical Biomarker and Patient Data: First MoDE and TRAP Extracellular Protein Degraders Achieve Deep, Rapid, Selective Lowering of Disease-Driving Antibodies in Graves' Dise

Wed, 27 May 2026 07:30:00 -0400

BHV-1300 demonstrated deep, rapid, and sustained lowering of pathogenic TSHR autoantibodies (TSHR-IgG1) in patients with Graves' hyperthyroidism receiving 1000 mg SC weekly, with mean reductions in TSHR-IgG1exceeding >80% over the 12-week study.
Participants with Graves' overt hyperthyroidism, confirmed by elevated baseline thyroid tests despite being treated with anti-thyroid drug therapy (ATD), experienced normalization of thyroid hormones within weeks; T4 normalization occurring at a median of 3 weeks and T3 at a median of 5 weeks after the first administration of BHV-1300.
These preliminary patient data from an ongoing Phase 1b study highlight deep lowering of TSHR-IgG1 with BHV-1300 as

Biohaven Reports Positive Clinical Biomarker and Patient Data: First MoDE and TRAP Extracellular Protein Degraders Achieve Deep, Rapid, Selective Lowering of Disease-Driving Antibodies in Graves' Dise

Wed, 27 May 2026 07:30:00 -0400

BHV-1300 demonstrated deep, rapid, and sustained lowering of pathogenic TSHR autoantibodies (TSHR-IgG1) in patients with Graves' hyperthyroidism receiving 1000 mg SC weekly, with mean reductions in TSHR-IgG1exceeding >80% over the 12-week study.
Participants with Graves' overt hyperthyroidism, confirmed by elevated baseline thyroid tests despite being treated with anti-thyroid drug therapy (ATD), experienced normalization of thyroid hormones within weeks; T4 normalization occurring at a median of 3 weeks and T3 at a median of 5 weeks after the first administration of BHV-1300.
These preliminary patient data from an ongoing Phase 1b study highlight deep lowering of TSHR-IgG1 with BHV-1300 as

Biohaven Reports Positive Clinical Biomarker and Patient Data: First MoDE and TRAP Extracellular Protein Degraders Achieve Deep, Rapid, Selective Lowering of Disease-Driving Antibodies in Graves' Dise

Wed, 27 May 2026 07:30:00 -0400

BHV-1300 demonstrated deep, rapid, and sustained lowering of pathogenic TSHR autoantibodies (TSHR-IgG1) in patients with Graves' hyperthyroidism receiving 1000 mg SC weekly, with mean reductions in TSHR-IgG1exceeding >80% over the 12-week study.
Participants with Graves' overt hyperthyroidism, confirmed by elevated baseline thyroid tests despite being treated with anti-thyroid drug therapy (ATD), experienced normalization of thyroid hormones within weeks; T4 normalization occurring at a median of 3 weeks and T3 at a median of 5 weeks after the first administration of BHV-1300.
These preliminary patient data from an ongoing Phase 1b study highlight deep lowering of TSHR-IgG1 with BHV-1300 as

Biohaven Reports Positive Clinical Biomarker and Patient Data: First MoDE and TRAP Extracellular Protein Degraders Achieve Deep, Rapid, Selective Lowering of Disease-Driving Antibodies in Graves' Dise

Wed, 27 May 2026 07:30:00 -0400

BHV-1300 demonstrated deep, rapid, and sustained lowering of pathogenic TSHR autoantibodies (TSHR-IgG1) in patients with Graves' hyperthyroidism receiving 1000 mg SC weekly, with mean reductions in TSHR-IgG1exceeding >80% over the 12-week study.
Participants with Graves' overt hyperthyroidism, confirmed by elevated baseline thyroid tests despite being treated with anti-thyroid drug therapy (ATD), experienced normalization of thyroid hormones within weeks; T4 normalization occurring at a median of 3 weeks and T3 at a median of 5 weeks after the first administration of BHV-1300.
These preliminary patient data from an ongoing Phase 1b study highlight deep lowering of TSHR-IgG1 with BHV-1300 as

Biohaven Reports Positive Clinical Biomarker and Patient Data: First MoDE and TRAP Extracellular Protein Degraders Achieve Deep, Rapid, Selective Lowering of Disease-Driving Antibodies in Graves' Dise

Wed, 27 May 2026 07:30:00 -0400

BHV-1300 demonstrated deep, rapid, and sustained lowering of pathogenic TSHR autoantibodies (TSHR-IgG1) in patients with Graves' hyperthyroidism receiving 1000 mg SC weekly, with mean reductions in TSHR-IgG1exceeding >80% over the 12-week study.
Participants with Graves' overt hyperthyroidism, confirmed by elevated baseline thyroid tests despite being treated with anti-thyroid drug therapy (ATD), experienced normalization of thyroid hormones within weeks; T4 normalization occurring at a median of 3 weeks and T3 at a median of 5 weeks after the first administration of BHV-1300.
These preliminary patient data from an ongoing Phase 1b study highlight deep lowering of TSHR-IgG1 with BHV-1300 as

Biohaven Reports Positive Clinical Biomarker and Patient Data: First MoDE and TRAP Extracellular Protein Degraders Achieve Deep, Rapid, Selective Lowering of Disease-Driving Antibodies in Graves' Dise

Wed, 27 May 2026 07:30:00 -0400

BHV-1300 demonstrated deep, rapid, and sustained lowering of pathogenic TSHR autoantibodies (TSHR-IgG1) in patients with Graves' hyperthyroidism receiving 1000 mg SC weekly, with mean reductions in TSHR-IgG1exceeding >80% over the 12-week study.
Participants with Graves' overt hyperthyroidism, confirmed by elevated baseline thyroid tests despite being treated with anti-thyroid drug therapy (ATD), experienced normalization of thyroid hormones within weeks; T4 normalization occurring at a median of 3 weeks and T3 at a median of 5 weeks after the first administration of BHV-1300.
These preliminary patient data from an ongoing Phase 1b study highlight deep lowering of TSHR-IgG1 with BHV-1300 as

Biohaven Reports Positive Clinical Biomarker and Patient Data: First MoDE and TRAP Extracellular Protein Degraders Achieve Deep, Rapid, Selective Lowering of Disease-Driving Antibodies in Graves' Dise

Wed, 27 May 2026 07:30:00 -0400

BHV-1300 demonstrated deep, rapid, and sustained lowering of pathogenic TSHR autoantibodies (TSHR-IgG1) in patients with Graves' hyperthyroidism receiving 1000 mg SC weekly, with mean reductions in TSHR-IgG1exceeding >80% over the 12-week study.
Participants with Graves' overt hyperthyroidism, confirmed by elevated baseline thyroid tests despite being treated with anti-thyroid drug therapy (ATD), experienced normalization of thyroid hormones within weeks; T4 normalization occurring at a median of 3 weeks and T3 at a median of 5 weeks after the first administration of BHV-1300.
These preliminary patient data from an ongoing Phase 1b study highlight deep lowering of TSHR-IgG1 with BHV-1300 as

Biohaven Reports Positive Clinical Biomarker and Patient Data: First MoDE and TRAP Extracellular Protein Degraders Achieve Deep, Rapid, Selective Lowering of Disease-Driving Antibodies in Graves' Dise

Wed, 27 May 2026 07:30:00 -0400

BHV-1300 demonstrated deep, rapid, and sustained lowering of pathogenic TSHR autoantibodies (TSHR-IgG1) in patients with Graves' hyperthyroidism receiving 1000 mg SC weekly, with mean reductions in TSHR-IgG1exceeding >80% over the 12-week study.
Participants with Graves' overt hyperthyroidism, confirmed by elevated baseline thyroid tests despite being treated with anti-thyroid drug therapy (ATD), experienced normalization of thyroid hormones within weeks; T4 normalization occurring at a median of 3 weeks and T3 at a median of 5 weeks after the first administration of BHV-1300.
These preliminary patient data from an ongoing Phase 1b study highlight deep lowering of TSHR-IgG1 with BHV-1300 as