Biohaven Ltd (NYSE:BHVN) shares were up 7.6% on May 31 after the firm delivered an update on clinical progress and regulatory updates on its pipeline candidates at its R&D Day.
Biohaven said, as part of its regulatory updates, that it submitted a new drug application (NDA) for troriluzole, one of its most advanced pipeline candidates, in the second quarter of 2023. Troriluzole’s NDA seeks clearance to treat spinocerebellar ataxia type 3 (SCA3), an extremely rare neurological condition linked with progressive impairment.
This NDA is backed up by data from a phase III research (BHV4157-206) in which troriluzole medication resulted in benefits across numerous outcome measures in study participants. The FDA has also given troriluzole fast-track and orphan drug designations in the SCA indication. The candidate is also being developed for obsessive-compulsive disorder (OCD) in two late-stage studies.
The business also stated that it aims to complete enrollment in the worldwide phase III study testing another candidate, taldefgrobep alfa, in spinal muscular atrophy (SMA) by the end of this year. In addition, management plans to begin phase II research later this year to investigate this medication in metabolic diseases.
Biohaven shares have climbed 26.2% this year, compared to a 9.7% decline in the industry.
Biohaven also provided clinical updates on several of its pre-clinical/early-stage pipeline candidates. It said that it has moved BHV-8000, a TYK-1/JAK1 inhibitor for the treatment of brain diseases, to the clinical stage. A phase I research to test BHV-8000 in healthy volunteers was just launched by management. Hangzhou Highlightll Pharmaceutical Co. Ltd. in China purchased the candidate in March 2023.
The company also announced plans to begin a phase I EEG research to test BHV-7000, a Kv7.2/3 activator, in the first half of 2023. By the end of this year, management plans to begin pivotal clinical studies examining the candidate in the indications of focal epilepsy and bipolar illness.
In addition to the above updates, BHVN intends to submit investigational new drug (IND) applications to the FDA in order to begin clinical trials on numerous pipeline prospects. This includes BHV-1300, a new IgG degrader whose IND application is due later this year.
Biohaven currently has no approved medications in its portfolio and relies on its pipeline for growth. The company is a new publicly traded company that has kept legacy Biohaven’s non-calcitonin gene-related peptide (CGRP) development stage pipeline products.
Last year, the company announced the acquisition of its CGRP business by Pfizer (NYSE:PFE) for $148.50 per share or an aggregate equity value of $11.6 billion. Following this acquisition, Biohaven has concentrated on developing non-CGRP pipeline medicines for neurological and neuropsychiatric illnesses such as SMA, SCA, and OCD. Pfizer also added legacy Biohaven’s single-marketed medicine Nurtec ODT to its product portfolio as a result of the acquisition. Pfizer also expanded its medication portfolio with Biohaven’s other CGRP initiatives, including zavegepant nasal spray. In March, the FDA approved Zavegepant for the acute treatment of migraine. This spray is marketed by Pfizer under the brand name Zavzpret.
Featured Image: Freepik @ prostooleh
Author Stephanie Bédard-Châteauneuf 
