BHVN Biohaven Pharmaceutical Holding Company Ltd.

75.89
-2.06  -3%
Previous Close 77.95
Open 77.96
52 Week Low 26.56
52 Week High 78.75
Market Cap $4,442,005,015
Shares 58,532,152
Float 42,528,719
Enterprise Value $4,134,342,248
Volume 486,461
Av. Daily Volume 842,393
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Upcoming Catalysts

Drug Stage Catalyst Date
TRORILUZOLE
Alzheimer’s disease
Phase 2
Phase 2
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TRORILUZOLE
Spinocerebellar Ataxia (SCA)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
TRORILUZOLE
Obsessive compulsive disorder (OCD)
Phase 2/3
Phase 2/3
Phase 2/3 top-line data did not meet primary endpoint - June 24, 2020.
Rimegepant
Refractory trigeminal neuralgia
Phase 2
Phase 2
Phase 2 trial continues to enrol as of May 2020.
Verdiperstat
Multiple system atrophy (MSA)
Phase 3
Phase 3
Phase 3 trial continues to enrol as of May 2020.
Vazegepant
COVID-19 Coronavirus associated pulmonary complications
Phase 2
Phase 2
Phase 2 trial planned. IND submission announced April 9, 2020.
Rimegepant
Migraine - preventative
Phase 3
Phase 3
Phase 3 top-line data met primary endpoint - March 30, 2020.
Vazegepant
Acute treatment of migraine
Phase 3
Phase 3
Phase 3 trial to be initiated mid-2020.
Rimegepant Zydis ODT
Acute treatment of migraine
Approved
Approved
FDA Approval announced February 27, 2020.
TRORILUZOLE
Generalized anxiety disorder (GAD)
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - February 10, 2020.
Nurtec (riluzole) (BHV-0223)
Amyotrophic lateral sclerosis (ALS)
CRL
CRL
CRL issued July 19, 2019.

Latest News

  1. NEW HAVEN, Conn., July 08, 2020 (GLOBE NEWSWIRE) -- Kleo Pharmaceuticals, a leading company in the field of developing next-generation, fully synthetic bispecific compounds designed to emulate or enhance the activity of biologics, announced today that it has received a $5 million grant from the Bill & Melinda Gates Foundation to advance the development of Kleo's COVID-19 treatment leveraging its MATE™ (Monoclonal Antibody Therapy Enhancers) technology platform to combat the SARS-CoV-2 virus.

    Kleo's MATE technology uses site-directed, chemical conjugation with off-the-shelf therapeutic antibodies to add to or enhance their functionality. Kleo has developed a series of binders that target the Spike protein of SARS-CoV-2 to conjugate with…

    NEW HAVEN, Conn., July 08, 2020 (GLOBE NEWSWIRE) -- Kleo Pharmaceuticals, a leading company in the field of developing next-generation, fully synthetic bispecific compounds designed to emulate or enhance the activity of biologics, announced today that it has received a $5 million grant from the Bill & Melinda Gates Foundation to advance the development of Kleo's COVID-19 treatment leveraging its MATE™ (Monoclonal Antibody Therapy Enhancers) technology platform to combat the SARS-CoV-2 virus.

    Kleo's MATE technology uses site-directed, chemical conjugation with off-the-shelf therapeutic antibodies to add to or enhance their functionality. Kleo has developed a series of binders that target the Spike protein of SARS-CoV-2 to conjugate with commercially available intravenous immunoglobulin (IVIG) plasma product to create a hyperimmune globulin mimic (HGM) therapeutic. HGM therefore could represent a synthetic, readily available, targeted and homogenous replacement of convalescent serum that has shown promise as treatment for COVID-19 disease. HGM can address COVID-19 viral infection by multiple mechanisms: direct neutralization, viral clearance through innate immune system and longer-term vaccination-like effects. Unlike traditional monoclonal therapeutic antibodies which are based on a single immunoglobulin (IgG) subclass, Kleo's HGM product for COVID-19 consists of IgG1/2/4 antibodies, therefore conferring a unique multimodal effect.

    Kleo has previously demonstrated proof-of-concept for the MATE conjugation technology with commercial-grade IVIG in a preclinical in vivo oncology model.

    "We are thrilled to receive grant funding from the Bill & Melinda Gates Foundation to accelerate development of our COVID-19 HGM program and potentially help address this urgent global need," said Doug Manion, MD, CEO of Kleo Pharmaceuticals. "From Kleo's initial work in HIV and my 20 plus years of experience in developing successful anti-viral medicines, the COVID-19 program represents an important component and natural evolution of the Kleo story. This non-dilutive funding allows us to rapidly advance clinical candidate identification efforts with the goal of entering the clinic in early 2021."

    In addition to the COVID-19 HGM program, Kleo has also recently established collaborations with South Korea-based Green Cross LabCell (GCLC), a subsidiary of Green Cross Corporation, and U.S.-based Celularity, Inc. to explore and develop COVID-19 therapies using its antibody recruiting molecule (ARM™) technology in combination with allogeneic NK cells.

    About Kleo Pharmaceuticals, Inc.

    Kleo Pharmaceuticals is a unique biotechnology company developing next-generation, bispecific compounds designed to emulate or enhance the activity of biologics based on the groundbreaking research of its scientific founder Dr. David Spiegel at Yale University. Kleo's compounds are designed to direct the immune system to destroy cancerous or virally infected cells and are currently in development for the treatment of various diseases, including multiple myeloma and COVID-19. Compared to biologics, Kleo's compounds are smaller and more versatile, leading to potentially improved safety and efficacy. They are also much faster and more efficient to design and produce, particularly against novel targets. Kleo develops drug candidates based on its proprietary technology platforms, all of which are modular in design and enable rapid generation of novel immunotherapies that can be optimized against specified biological targets and combined with existing cell- or antibody-based therapies. These include Antibody Recruiting Molecules (ARMs) and Monoclonal Antibody Therapy Enhancers (MATEs). Biohaven Pharmaceutical Holding Company (NYSE:BHVN) and PeptiDream Inc. (Nikkei: PPTDF) are investors in Kleo Pharmaceuticals.  For more information visit http://kleopharmaceuticals.com.

    CONTACT INFORMATION

    LifeSci Advisors (Investors)

    Irina Koffler

    646-970-4681

    Susan Kinkead (Media)

    415-509-3610



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  2. NEW HAVEN, Conn., June 24, 2020 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE:BHVN) today reported topline results from its proof of concept study of troriluzole in the treatment of obsessive-compulsive disorder (OCD). 

    Table 1 shows the mean change in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score over time. Troriluzole treated subjects had a mean Y-BOCS improvement of -5.1 points from baseline versus -3.6 for placebo-treated subjects [difference -1.5, p-value=0.041, 95% CI: -3.02, -0.06] at week 8, and -5.9 points versus -4.9 for placebo subjects [difference -1.0, p-value = 0.220, 95% CI: -2.59, 0.60] at week 12. Although the p-value in this proof of concept study did not reach statistical significance at the primary Y-BOCS endpoint at week 12, the results reveal a consistent treatment benefit of troriluzole over time and provide the appropriate data to power future studies.

    Table 1: Troriluzole Effect on OCD in Phase 2/3 Trial1 

    Y-BOCS Total

    Change from

    Baseline

    Week

    4

    (N=115a, 111b)

    8

    (N=108a, 96b)

    12

    (N=102a, 99b)

    Placeboa

    -2.9

    -3.6

    -4.9

    Troriluzoleb

    -3.4

      -5.1*

    -5.9

    p-value

    0.451

    0.041

    0.220

    1. BHV4157-202 Final Unblinded Analysis YBOCS Total Change from Baseline by Week

    LSMeans from MMRM Model MITT Data Set

    * p < 0.05 versus placebo



    Troriluzole treatment differences compared to placebo were greater in patients who were more severely ill at baseline (i.e., Y-BOCs total scores greater than the median score of 26, representing severe OCD symptoms), see Table 2. Troriluzole treated subjects (n=42) had a mean Y-BOCS change from baseline of -6.0 points versus -3.1 for placebo (n=45) subjects [difference -2.9, p=0.035, 95% CI: -5.49, -0.21] at week 8, and -7.0 points (n=44) versus -4.6 for placebo (n=43) subjects [treatment difference -2.4, p = 0.084, 95% CI: -5.18, 0.33] at week 12.

    Table 2: Troriluzole Effect on Patients with Severe OCD1 

    Y-BOCS Total

    Change from

    Baseline

    Week

    4

    (N=47a, 49b)

    8

    (N=45a, 42b)

    12

    (N=43a, 44b)

    Placeboa

    -3.5

    -3.1

    -4.6

    Troriluzoleb

    -4.1

      -6.0*

    -7.0

    p-value

    0.584

    0.035

    0.084

    1. Patients at baseline with median Y-BOCS total scores > 26 (severe OCD symptoms).

    * p < 0.05 versus placebo







    Vlad Coric, M.D., Chief Executive Officer of Biohaven, "While we have focused our primary investment to date on our lead CGRP program for migraine, we advanced troriluzole in a series of proof of concept trials to assess signal detection across disease states.  Our strategy is to only further invest in troriluzole indications where we find an emerging drug signal.  We are pleased to report these OCD study results that show a consistent and clinically meaningful drug effect at all study timepoints in patients who had an inadequate response to existing standard of care treatments. This study provides our R&D team with the necessary data to refine and adequately power subsequent trials to advance troriluzole in OCD. Based upon these results, we will have an End of Phase 2 meeting with the FDA and plan to initiate an appropriately powered pivotal Phase 3 study of two doses of troriluzole versus placebo."

    Obsessive-compulsive disorder is a serious psychiatric condition affecting over 2 million individuals in the U.S. and significantly impacts quality of life. Approximately 40% to 60% of OCD patients continue to experience significant residual symptoms despite approved therapies. Some refractory patients undergo psychosurgery (cingulotomy or deep brain stimulation) to alleviate their crippling symptoms.

    Dr. Christopher Pittenger, M.D., Ph.D., Associate Professor of Psychiatry and Director of the Yale OCD Research Clinic, who was an investigator in the trial, commented, "As the first large scale, double-blind trial of troriluzole in OCD, this proof-of-concept study provides extremely encouraging initial data.  OCD affects one person in 40 and can be debilitating. Fully a third of patients do not respond to current treatments, and many who do respond continue to suffer from residual symptoms.  New therapies are urgently needed to alleviate this suffering and disability.  There has not been a mechanistically novel medication approved for OCD in over 20 years.   If troriluzole proves to be effective for these patients, it would be a huge advance.   I look forward to working with Biohaven to explore the data from this proof-of-concept trial in more depth, to inform the design of future pivotal studies."

    Loren Aguiar, M.D., Biohaven's Vice President of Research and Development stated, "The team conducted a well-designed, comprehensive proof of concept trial which has provided a wealth of data about the use of troriluzole as adjunctive therapy in OCD.  We are continuing to analyze these data to investigate additional factors that may inform our next studies and further minimize placebo effect. The completion of the trial was complicated by the presence of restrictions surrounding the COVID-19 pandemic. We are grateful to the community of patients and researchers who persevered, allowing us to undertake and complete this challenging study."

    Biohaven has a deep and broad portfolio of assets in development with five ongoing Phase 3 trials across its calcitonin gene-related peptide (CGRP) antagonists, glutamate modulators and myeloperoxidase inhibitor platforms. Biohaven continues to focus resources on the NURTEC ODT launch for the acute treatment of migraine in adults, while preparing an sNDA submission for prevention.  Earlier this year, troriluzole dosed at 280 mg successfully advanced past an interim futility analysis, performed after 100 subjects completed 6 months of treatment, in its pivotal Phase 2/3 trial in Alzheimer's disease.  Completion of the trial for troriluzole in Alzheimer's Disease trial is expected in 4Q2020, and topline data from the troriluzole in SCA trial are anticipated in 2021. Additionally, Biohaven's verdiperstat trial in Multiple System Atrophy (MSA) is enrolling ahead of schedule with topline results also expected in 2021.

    About Troriluzole

    Troriluzole is a third-generation prodrug and new chemical entity that modulates glutamate, the most abundant excitatory neurotransmitter in the human body. The primary mode of action of troriluzole is normalization of synaptic levels of glutamate. Troriluzole increases glutamate uptake from the peri-synaptic space, by augmenting the expression and function of excitatory amino acid transporters (i.e., EAAT2 also called GLT-1) located on glial cells that play a key role in clearing glutamate from the synapse. More information about troriluzole can be found on the Company's website  https://www.biohavenpharma.com/science-pipeline/glutamate/troriluzole

    About Biohaven

    Biohaven is a biopharmaceutical company focused on the development and commercialization of innovative best-in-class therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases. Biohaven's neuroinnovation portfolio includes FDA-approved NURTEC™ ODT (rimegepant) for the acute treatment of migraine and a broad pipeline of late-stage product candidates across three distinct mechanistic platforms: CGRP receptor antagonism for the acute and preventive treatment of migraine; glutamate modulation for obsessive-compulsive disorder, Alzheimer's disease, and spinocerebellar ataxia; and myeloperoxidase (MPO) inhibition for multiple system atrophy and amyotrophic lateral sclerosis. For more information, visit www.biohavenpharma.com.

    Forward-Looking Statements

    This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of Biohaven's management. All statements, other than statements of historical facts, included in this press release, including the expected enrollment for Biohaven's Phase 2b/3 trial of troriluzole, the potential results of Biohaven's Phase 2b/3 trial of troriluzole in OCD, the potential for the Phase 2b/3 trial to be a pivotal trial, the role of glutamate in OCD, the possible benefits of troriluzole as adjunctive therapy compared to current standard of care for OCD patients, as well as the timetable for the topline data and completion of trials, are forward-looking statements. The use of certain words, including the "believe" and "will" and similar expressions are intended to identify forward-looking statements. Biohaven may not actually achieve the plans and objectives disclosed in the forward-looking statements and you should not place undue reliance on Biohaven's forward-looking statements. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements, including uncertainties relating to the future clinical success of troriluzole. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of Biohaven's Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 26, 2020 and Biohaven's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, filed with the Securities and Exchange Commission on May 7, 2020. The forward-looking statements are made as of this date 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.

    For further information, contact:

    Dr. Vlad Coric

    Chief Executive Officer

    NURTEC is a trademark of Biohaven Pharmaceutical Holding Company Ltd.

     

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  3. NEW HAVEN, Conn., June 16, 2020 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE:BHVN), today announced that it presented data from 25 accepted abstracts demonstrating the efficacy, safety, tolerability and pharmacoeconomic value of NURTEC™ (rimegepant) at the 2020 American Headache Society (AHS) Virtual Annual Scientific Meeting.

    In lieu of an in-person annual meeting, the AHS has decided to present portions of the Annual Scientific Meeting via a Virtual Meeting platform, which launched Saturday, June 13.

    Elyse Stock, M.D., Chief Medical Officer of Biohaven commented, "The extensive data set presented at the AHS Virtual Annual Meeting showcases the important benefits that NURTEC brings to patients.  The growing body of data continues to validate the rapid and durable efficacy of single dose NURTEC and safety in subpopulations with significant unmet need including people with cardiovascular risk and those who are currently taking preventive treatments for migraine."

    NURTEC ODT (rimegepant) is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist in an orally disintegrating tablet (ODT) approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine in adults. Rimegepant has also demonstrated efficacy in the preventive treatment of migraine and Biohaven is committed to advancing rimegepant as a "dual-acting" therapy with the goal of gaining approval as the first oral CGRP-targeting agent for both the acute and preventive treatment of migraine. In December 2019, the Company also announced positive topline results for its Phase 2/3 trial for vazegepant (BHV-3500), the first small molecule CGRP receptor antagonist to be administered in an intranasal formulation for the acute treatment of migraine.

    Biohaven has one oral and 24 poster presentations that are being showcased as part of the AHS virtual platform. Key highlights include: 

    Oral Presentation

    • Rimegepant 75 mg Provides Early and Sustained Relief of Migraine With a Single Oral Dose:  Results from 3 Phase 3 Clinical Trials

    Poster Presentations

    • Oral Rimegepant 75 mg is Safe and Well Tolerated in Adults With Migraine and Cardiovascular Risk Factors: Results of a Multicenter, Long-Term, Open-Label Safety Study
    • Low Rates of Rescue Medication Usage in Subjects Treated With a Single Dose of Rimegepant 75 mg for the Acute Treatment of Migraine: Results from 3 Phase 3 Clinical Trials
    • Rimegepant is Safe and Tolerable for the Acute Treatment of Migraine in Patients Using Preventive Migraine Medications: Results from a Long-Term Open-Label Safety Study (Study 201)
    • Lost-time is Associated with Total Health Care and Pharmaceutical Costs – A US-Based Real World Longitudinal Analysis
    • MIDAS Disability Grades are Associated with Total Health Care and Pharmaceutical Costs – A US-Based Real World Longitudinal Analysis

    A full list of presentations can be accessed here.

    About NURTEC ODT

    NURTEC™ ODT (rimegepant) is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a quick-dissolve ODT formulation that is approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine in adults. Nurtec ODT is not indicated for the preventive treatment of migraine. The activity of the neuropeptide CGRP is thought to play a causal role in migraine pathophysiology. NURTEC ODT is a CGRP receptor antagonist that works by reversibly blocking CGRP receptors, thereby inhibiting the biologic activity of the CGRP neuropeptide. NURTEC ODT has a relatively rapid Tmax (1.5 hours) and relatively long half-life (11 hours) which may account for rapid and sustained efficacy demonstrated with statistically significant improvement vs placebo on pain relief and ability to function normally at 60 minutes and sustained through 48 hours. The recommended dose of NURTEC ODT is 75 mg, taken as needed, up to once daily. For more information about NURTEC ODT, visit www.nurtec.com.

    Avoid concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4, strong or moderate inducers of CYP3A or inhibitors of P-gp or BCRP. Avoid another dose of NURTEC ODT within 48 hours when it is administered with moderate inhibitors of CYP3A4. The most common adverse reaction was nausea (2% in patients who received NURTEC ODT compared to 0.4% in patients who received placebo).

    About Migraine 

    Nearly 40 million people in the U.S. suffer from migraine and the World Health Organization classifies migraine as one of the 10 most disabling medical illnesses. Migraine is characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity that can be associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia). There is a significant unmet need for new acute treatments as more than 90 percent of migraine sufferers are unable to work or function normally during an attack.

    About CGRP Receptor Antagonism 

    Small molecule CGRP receptor antagonists represent a novel class of drugs for the treatment of migraine. This unique mode of action potentially offers an alternative to current agents, particularly for patients who have contraindications to the use of triptans, or who have a poor response to triptans or are intolerant to them.

    Indication

    NURTEC™ ODT (rimegepant) is indicated for the acute treatment of migraine with or without aura in adults.

    Limitations of Use 

    NURTEC ODT is not indicated for the preventive treatment of migraine.

    Important Safety Information

    Contraindications: Hypersensitivity to NURTEC ODT or any of its components.

    Warnings and Precautions: If a serious hypersensitivity reaction occurs, discontinue NURTEC ODT and initiate appropriate therapy. Serious hypersensitivity reactions have included dyspnea and rash, and can occur days after administration.

    Adverse Reactions: The most common adverse reaction was nausea (2% in patients who received NURTEC ODT compared to 0.4% in patients who received placebo). Hypersensitivity, including dyspnea and rash, occurred in less than 1% of patients treated with NURTEC ODT.

    Drug Interactions: Avoid concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4, strong or moderate inducers of CYP3A or inhibitors of P-gp or BCRP. Avoid another dose of NURTEC ODT within 48 hours when it is administered with moderate inhibitors of CYP3A4.

    Use in Specific Populations:

    1. Pregnant/breast feeding: It is not known if NURTEC ODT can harm an unborn baby or if it passes into breast milk.  
    2. Hepatic impairment: Avoid use of NURTEC ODT in persons with severe hepatic impairment.  
    3. Renal impairment: Avoid use in patients with end-stage renal disease.

    Please click here for full Prescribing information.

    You are encouraged to report side effects of prescription drugs to the FDA.

    Visit www.fda.gov/medwatch or call 1-800-FDA-1088 or report side effects to Biohaven at 1-833-4Nurtec. Please click here for full Prescribing information and Patient Information.

    About Biohaven

    Biohaven is a biopharmaceutical company focused on the development and commercialization of innovative best-in-class therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases. Biohaven's neuroinnovation portfolio includes FDA-approved NURTEC™ ODT (rimegepant) for the acute treatment of migraine and a broad pipeline of late-stage product candidates across three distinct mechanistic platforms: CGRP receptor antagonism for the acute and preventive treatment of migraine; glutamate modulation for obsessive-compulsive disorder, Alzheimer's disease, and spinocerebellar ataxia; and myeloperoxidase (MPO) inhibition for multiple system atrophy and amyotrophic lateral sclerosis. For more information, visit www.biohavenpharma.com.

    Forward-looking Statement

    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 "believe", "continue", "may", and "will" and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of Biohaven's management about NURTEC ODT as an acute treatment for patients with migraine. Forward-looking statements include those related to: Biohaven's ability to effectively commercialize NURTEC ODT, delays or problems in the supply or manufacture of NURTEC ODT, complying with applicable U.S. regulatory requirements, the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials, the timing of planned interactions and filings with the FDA, the timing and outcome of expected regulatory filings, the potential commercialization of Biohaven's product candidates, the potential for Biohaven's product candidates to be first in class or best in class therapies and the effectiveness and safety of Biohaven's product candidates. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of Biohaven's Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 26, 2020 and Biohaven's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, filed with the Securities and Exchange Commission on May 7, 2020. The forward-looking statements are made as of this date 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.

    Biohaven Contact:

    Vlad Coric, M.D.

    Chief Executive Officer

    Media Contact:

    Mike Beyer

    Sam Brown Inc.

     

    312-961-2502

    NURTEC is a trademark of Biohaven Pharmaceutical Holding Company Ltd.

    Copyright © 2020 Biohaven. All rights reserved.

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  4. NEW HAVEN, Conn., June 10, 2020 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE:BHVN), today announced the appointment of pharmaceutical industry leader Robert J. Hugin to its Board of Directors, effective immediately. Mr. Hugin previously served as the Chairman and Chief Executive Officer of Celgene Corporation where he was instrumental in the strategic growth and global expansion of the company. Celgene was ultimately acquired by Bristol-Myers Squibb in 2019 for a total equity value of approximately $74 billion.

    Declan Doogan, M.D., Chairman of Biohaven's Board of Directors, commented, "We are excited to welcome Bob to Biohaven's Board of Directors as we have evolved to a commercial organization and look to the future. Having access to Bob's astute business and financial acumen will help Biohaven achieve our goal of becoming the leading pharmaceutical company focused on neuroscience indications."

    Mr. Hugin joined Celgene in 1999 as Chief Financial Officer and served in positions of increasing responsibility during his 19-year tenure with the company, including Executive Chairman, Chief Executive Officer, President and Chief Operating Officer. Until his retirement in 2018, he was the Chairman of the Board of Directors, serving as Executive Chairman from 2016 to 2018. Under his leadership, Celgene saw unprecedented results across all facets of the company and grew by over $30 billion in market capitalization. He is a noted health expert, who advocated for the importance of business development collaborations, innovations in science and improved patient access.

    Mr. Hugin stated, "Neuroscience remains one of the most important areas for drug development given the high burden of disability from diseases like Alzheimer's disease, rare neurologic indications,  neuropsychiatric disorders and migraine. Biohaven has achieved impressive progress in its portfolio development since becoming a public company and is now successfully commercializing NURTEC ODT, its first product, for migraine. I hope to help transform Biohaven from a development company to a high growth commercial organization with multiple future products addressing large unmet needs in the neuroscience area. I look forward to being part of Biohaven's future success and working closely with Vlad and the rest of the Board."

    Vlad Coric, M.D., Chief Executive Officer of Biohaven commented, "Biohaven is honored to welcome Bob to our Board of Directors. His impressive industry experience with high growth companies, strategic insight and passion for improving the lives of patients will be an asset to Biohaven in this time of significant growth as we continue to successfully commercialize our first product and advance our late-stage development portfolio.  We are indeed fortunate to have Bob's extraordinary business and financial expertise to help guide Biohaven in advancing novel therapies to patients suffering from disabling neuroscience conditions."

    Mr. Hugin also serves as a Director of Chubb Limited, Member of the Board of Trustees of Princeton University and Chair of The Darden School Foundation, University of Virginia. Additionally, Mr. Hugin is currently Chair of the Board of the Garden State Initiative, a nonpartisan research and educational organization focused on economic issues in New Jersey. He is a longstanding Member of the Board of Trustees of Family Promise, a national non-profit network assisting homeless families, and Director of the Parker Institute for Cancer Immunotherapy. Mr. Hugin is past Chairman of the Boards of The Pharmaceutical Research and Manufacturers of America and the Healthcare Institute of NJ. Prior to joining Celgene, Mr. Hugin was a Managing Director with J.P. Morgan & Co. Inc.

    Mr. Hugin received an AB degree from Princeton University in 1976 and an MBA from the University of Virginia in 1985. He also served as a United States Marine Corps infantry officer during the intervening period.

    About Biohaven

    Biohaven is a biopharmaceutical company focused on the development and commercialization of innovative best-in-class therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases. Biohaven's neuroinnovation portfolio includes FDA-approved NURTEC™ ODT (rimegepant) for the acute treatment of migraine and a broad pipeline of late-stage product candidates across three distinct mechanistic platforms: CGRP receptor antagonism for the acute and preventive treatment of migraine; glutamate modulation for obsessive-compulsive disorder, Alzheimer's disease, and spinocerebellar ataxia; and myeloperoxidase (MPO) inhibition for multiple system atrophy and amyotrophic lateral sclerosis. For more information, visit www.biohavenpharma.com.

    Forward-looking Statement

    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 "believe", "continue", "may", and "will" and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of Biohaven's management about NURTEC ODT as an acute treatment for patients with migraine. Forward-looking statements include those related to: Biohaven's ability to effectively commercialize NURTEC ODT, delays or problems in the supply or manufacture of NURTEC ODT, complying with applicable U.S. regulatory requirements, the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials, the timing of planned interactions and filings with the FDA, the timing and outcome of expected regulatory filings, the potential commercialization of Biohaven's product candidates, the potential for Biohaven's product candidates to be first in class or best in class therapies and the effectiveness and safety of Biohaven's product candidates. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of Biohaven's Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 26, 2020 and Biohaven's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 2020 filed with the Securities and Exchange Commission on May 7, 2020. The forward-looking statements are made as of this date 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.

    Biohaven Contact:

    Vlad Coric, M.D.

    Chief Executive Officer

    Media Contact:

    Mike Beyer

    Sam Brown Inc.



    312-961-2502

    NURTEC is a trademark of Biohaven Pharmaceutical Holding Company Ltd.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/biohaven-appoints-bob-hugin-to-its-board-of-directors-301073326.html

    SOURCE Biohaven Pharmaceutical Holding Company Ltd.

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  5. NEW HAVEN, Conn., June 01, 2020 (GLOBE NEWSWIRE) -- Kleo Pharmaceuticals, Inc., a leading company in the field of developing next-generation, fully synthetic bispecific compounds designed to emulate or enhance the activity of biologics, today announced that it will present at the Jefferies Virtual Healthcare Conference 2020 on Thursday, June 4, 2020 at 4:00 p.m. ET.

    Doug Manion, MD, CEO and Chairman of the Board of Kleo Pharmaceuticals will provide an overview of Kleo's antibody recruiting molecule (ARMTM) and monoclonal antibody therapy enhancer (MATETM) platforms in the context of the Company's multiple myeloma and COVID-19 programs. A link to the live webcast and replay of the Company's presentation will be available here.

    About Kleo Pharmaceuticals,

    NEW HAVEN, Conn., June 01, 2020 (GLOBE NEWSWIRE) -- Kleo Pharmaceuticals, Inc., a leading company in the field of developing next-generation, fully synthetic bispecific compounds designed to emulate or enhance the activity of biologics, today announced that it will present at the Jefferies Virtual Healthcare Conference 2020 on Thursday, June 4, 2020 at 4:00 p.m. ET.

    Doug Manion, MD, CEO and Chairman of the Board of Kleo Pharmaceuticals will provide an overview of Kleo's antibody recruiting molecule (ARMTM) and monoclonal antibody therapy enhancer (MATETM) platforms in the context of the Company's multiple myeloma and COVID-19 programs. A link to the live webcast and replay of the Company's presentation will be available here.

    About Kleo Pharmaceuticals, Inc.

    Kleo Pharmaceuticals is a unique biotechnology company developing next-generation, bispecific compounds designed to emulate or enhance the activity of biologics based on the groundbreaking research of its scientific founder Dr. David Spiegel at Yale University. Kleo's compounds are designed to direct the immune system to destroy cancerous or virally infected cells and are currently in development for the treatment of various diseases, including multiple myeloma and COVID-19. Compared to biologics, Kleo's compounds are smaller and more versatile, leading to potentially improved safety and efficacy. They are also much faster and more efficient to design and produce, particularly against novel targets. Kleo develops drug candidates based on its proprietary technology platforms, all of which are modular in design and enable rapid generation of novel immunotherapies that can be optimized against specified biological targets and combined with existing cell- or antibody-based therapies. These include Antibody Recruiting Molecules (ARMs) and Monoclonal Antibody Therapy Enhancers (MATEs). Biohaven Pharmaceutical Holding Company (NYSE:BHVN) and PeptiDream Inc. (TYO:4587) are investors in Kleo Pharmaceuticals.  For more information visit http://kleopharmaceuticals.com.

    Forward-Looking Statements

    This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of the Company's management. All statements, other than statements of historical facts, included in this press release regarding the Company's plans and objectives, expectations and assumptions of management are forward-looking statements. The use of certain words, including the words "estimate," "project," "intend," "expect," "believe," "anticipate," "will," "plan," "could," "may" and similar expressions are intended to identify forward-looking statements. The forward-looking statements are made as of this date and the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

    CONTACT INFORMATION
    LifeSci Advisors (Investors)
    Irina Koffler
    646-970-4681

    Kleo Pharmaceuticals (Media)
    Brian Dowd
    (203) 643-9172

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