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Biohaven Pharmaceutical Holding Company Ltd (BHVN.N)

BHVN.N on New York Stock Exchange

33.13USD
15 Aug 2018
Change (% chg)

$0.34 (+1.04%)
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Latest Key Developments (Source: Significant Developments)

Biohaven Announces Robust Clinical Data With Single Dose Rimegepant That Defines Acute And Durable Benefits To Patients
Monday, 23 Apr 2018 

April 22 (Reuters) - Biohaven Pharmaceutical Holding Company Ltd ::BIOHAVEN ANNOUNCES ROBUST CLINICAL DATA WITH SINGLE DOSE RIMEGEPANT THAT DEFINES ACUTE AND DURABLE BENEFITS TO PATIENTS.BIOHAVEN PHARMACEUTICAL HOLDING SAYS BROAD AND CLINICALLY IMPORTANT BENEFITS BEYOND INITIAL REGISTRATIONAL ENDPOINTS ARE NOW REPORTED..BIOHAVEN- RIMEGEPANT FIRST ORAL CGRP RECEPTOR ANTAGONIST TO DELIVER POSITIVE DATA ON PAIN FREEDOM IN TWO PIVOTAL PHASE 3 TRIALS IN ACUTE TREATMENT OF MIGRAINE.  Full Article

Biohaven Says Achieved Both Co-Primary Regulatory Endpoints In Two Pivotal Phase 3 Trials Of Rimegepant
Monday, 26 Mar 2018 

March 26 (Reuters) - Biohaven Pharmaceutical Holding Company Ltd ::BIOHAVEN ANNOUNCES SUCCESSFUL ACHIEVEMENT OF BOTH CO-PRIMARY REGULATORY ENDPOINTS IN TWO PIVOTAL PHASE 3 TRIALS OF RIMEGEPANT AN ORAL CGRP RECEPTOR ANTAGONIST FOR THE ACUTE TREATMENT OF MIGRAINE.RESULTS ARE STATISTICALLY SIGNIFICANT AND CLINICALLY MEANINGFUL ACROSS MULTIPLE OUTCOME MEASURES.EFFICACY AND SAFETY RESULTS WERE CONSISTENT ACROSS BOTH PHASE 3 TRIALS..ON SCHEDULE TO SUBMIT AN NDA FOR RIMEGEPANT IN 2019​.  Full Article

Biohaven Completes Enrollment In Second Pivotal Phase 3 Clinical Trial Of Oral CGRP-Receptor Antagonist Rimegepant
Monday, 27 Nov 2017 

Nov 27 (Reuters) - Biohaven Pharmaceutical Holding Company Ltd ::BIOHAVEN COMPLETES ENROLLMENT IN SECOND PIVOTAL PHASE 3 CLINICAL TRIAL OF ORAL CGRP-RECEPTOR ANTAGONIST RIMEGEPANT.  Full Article

Biohaven Pharma qtrly loss per share $1.19‍​
Tuesday, 14 Nov 2017 

Nov 14 (Reuters) - Biohaven Pharmaceutical Holding Company Ltd :Biohaven pharmaceuticals reports third quarter 2017 financial and business results.Biohaven pharmaceutical holding company ltd - qtrly loss per share $1.19‍​.  Full Article

Biohaven announces FDA clearance of IND application for sublingual BHV-0223
Wednesday, 1 Nov 2017 

Nov 1 (Reuters) - Biohaven Pharmaceutical Holding Company Ltd :Biohaven announces FDA clearance of IND application for sublingual bhv-0223 in patients with amyotrophic lateral sclerosis (ALS).‍U.S. FDA has notified that co may proceed with clinical investigation of sublingual bhv-0223 ​.Expects to submit an IND to FDA by end of this year for BHV-3500 for treatment of migraine​.Expects to commence a Bioequivalence study of BHV-0223 in the current quarter.  Full Article

Biohaven receives FDA may proceed letter for phase 2/3 clinical trial of Trigriluzole
Tuesday, 24 Oct 2017 

Oct 24 (Reuters) - Biohaven Pharmaceutical Holding Company Ltd :Biohaven receives FDA may proceed letter for phase 2/3 clinical trial of Trigriluzole in patients with obsessive-compulsive disorder.U.S. Food and drug administration (FDA) has notified co that it may proceed with its clinical investigation of Trigriluzole​.Expects to commence a phase 2/3 clinical trial of Trigriluzole in OCD in the current quarter.‍expects to report topline results in Q1 of 2018 for acute treatment of migraine​.Data from long-term safety study is expected to support a potential NDA submission in first half of 2019​.‍Also expects to file an IND with FDA by end of this year for BHV-3500 for treatment of migraine​.Anticipates commencing bioequivalence study for bhv-0223 for treatment of patients with ALS in Q4.  Full Article

Biohaven enters two separate subscription agreements with Kleo
Thursday, 12 Oct 2017 

Oct 12 (Reuters) - Biohaven Pharmaceutical Holding Company Ltd :Biohaven Pharmaceutical- ‍on Oct 5, co entered two separate subscription agreements with Kleo to maintain co's relative ownership interest in Kleo​.Biohaven Pharmaceutical - ‍pursuant to first subscription agreement, co purchased 1.4 million shares of Kleo's common stock at $1.0993 per share.Biohaven says ‍pursuant to second subscription agreement, co bought additional 651,639 shares of Kleo's common stock at $1.0993 per share​- SEC filing.  Full Article

Biohaven reports negative topline data from degenerative, genetic disease phase 2/3 trial
Monday, 2 Oct 2017 

Oct 2 (Reuters) - Biohaven Pharmaceutical Holding Company Ltd : :Biohaven reports negative topline data from spinocerebellar ataxia (sca) phase 2/3 trial.Biohaven Pharmaceutical Holding Company Ltd - ‍trigriluzole did not differentiate from placebo on primary endpoint or key secondary outcome​.Biohaven Pharmaceutical Holding Company Ltd - ‍trigriluzole was well tolerated and safely administered in study population​.Biohaven pharmaceutical - co affirms robust recruitment of its two phase 3 cgrp antagonist efficacy trials and expects topline results in q1 of 2018.Biohaven Pharmaceutical-for both cgrp phase-3 studies ‍long-term safety study expected to complete in q4 2018 to support potential h1 2019 nda submission​.Biohaven pharmaceutical holding company ltd - ‍biohaven also expects to file an ind with fda later this year for bhv-3500 for treatment of migraine​.Biohaven Pharmaceutical - expects to commence bioequivalence study for bhv-0223 for treatment of patients with amyotrophic lateral sclerosis in q4 2017.  Full Article