This Day That Year: Biohaven Pharma

(RTTNews) - Shares of Biohaven Pharmaceutical Holding Co. Ltd (BHVN) have returned 40% over the last 1 year while the iShares NASDAQ Biotechnology Index (ETF) has gained just 2% during the same period.

It was on this day last year, i.e. May 4, 2017, that Biohaven Pharmaceutical debuted on the Nasdaq by setting a public offering at $20.00 per share.

Biohaven is a clinical-stage biopharmaceutical company developing drugs for neurological diseases, including rare disorders.

The Company's lead drug candidate is Rimegepant (BHV-3000) for acute treatment of Migraine.

Rimegepant belongs to a class of drugs known as CGRP (calcitonin gene-related peptide) receptor antagonist. In clinical studies, CGRP receptor antagonists have been found to be effective as Triptans in the acute treatment of migraines, sans the cardiovascular effects.

The Company reported positive results from two pivotal phase III trials of Rimegepant 75 mg oral tablet for the acute treatment of migraine in March of this year.

Rimegepant met registrational co-primary endpoints of pain freedom, and freedom from most bothersome symptom at 2 hours in both the trials. An NDA for Rimegepant for the acute treatment of migraine is expected to be filed in 2019.

A long term phase II/III safety trial of Rimegepant in patients with migraine was initiated last August. This study, designed to enroll roughly 2,000 patients in the U.S., has so far enrolled more than 1,000 patients. The Company expects enrollment to be completed by the end of the first half of 2018, with top line data scheduled for the fourth quarter of this year.

A phase III clinical trial of Zydis orally dissolving tablet formulation of Rimegepant for the acute treatment of migraine was initiated in February of this year, with topline results anticipated in the fourth quarter of 2018.

Another CGRP receptor antagonist, which the Company is developing, is BHV-3500 for the acute treatment and prevention of migraine. An investigational new drug application for BHV-3500 is expected to be submitted to the FDA in first half of 2018.

Also in the pipeline are:

-- Trigriluzole, a novel third-generation prodrug glutamate modulator, under a phase II/III clinical trial in patients with Obsessive-Compulsive Disorder, or OCD.

OCD, which affects 1-2% of the U.S. population, is a chronic and long-lasting disorder in which a person has uncontrollable, reoccurring thoughts (obsessions) and behaviors (compulsions) that he or she feels the urge to repeat over and over.

The phase II/III clinical trial of Trigriluzole is designed to enroll 226 OCD patients across approximately 35 sites in the United States.

-- Trigriluzole is also being explored in the indication of Spinocerebellar Ataxia, a rare inherited neurological disorder.

The topline results from a phase 2/3 clinical trial reported last October revealed that Trigriluzole did not differentiate from placebo on the primary endpoint or key secondary outcome measure at the end of the 8-week randomization phase in patients with spinocerebellar ataxia. However, Biohaven is continuing a long-term (48-week) extension study of Trigriluzole in this indication. The extension study is fully enrolled, and top line results are expected in the fourth quarter of 2018.

-- BHV-0223, an innovative sublingual formulation of Riluzole, as a potential treatment for patients with Amyotrophic Lateral Sclerosis, has successfully completed a bioequivalence study.

Riluzole, marketed as Rilutek and Teglutik, is currently the standard of care treatment for patients with Amyotrophic Lateral Sclerosis.

-- BHV-5000, which is being developed as a potential treatment for neuropsychiatric disorders such as Rett syndrome. The clinical development of BHV-5000 was initiated as recently as January of this year.

Partnerships:

Biohaven acquired the rights to Rimegepant and BHV-3500, pursuant to a license agreement with Bristol-Myers Squibb (BMY) in July 2016. The Company licensed BHV-5000 from AstraZeneca (AZN) in October 2016.

Key Numbers:

Accumulated deficit: $202.6 million (as of December 31, 2017) Revenue: Nil Cash on hand: $131.5 million Shares Outstanding: 38.61 million

BHVN has thus far hit a low of $16.50 and a high of $39.51. The stock closed Thursday's trading at $28.00, down 3.38%.