Biohaven’s Troriluzole Set to Break Ground in Neurological Disorder With No Approved Meds

Biohaven (NYSE: BHVN), a clinical-stage biopharmaceutical company, has submitted a New Drug Application (NDA) to the US Food and Drug Administration for troriluzole, a potential treatment for spinocerebellar ataxia (SCA). The application follows a pre-NDA meeting in the fourth quarter of 2024.

SCA is a rare and debilitating neurodegenerative disorder affecting approximately 15,000 individuals in the U.S. and 24,000 in Europe and the U.K. With no FDA-approved treatments currently available, troriluzole could become the first drug to offer disease-modifying potential. In pivotal trials, troriluzole demonstrated a 50-70% slowing of disease progression over three years. The drug has received both Orphan Drug and Fast-Track designations from the FDA and qualifies for Priority Review.

Visible Alpha consensus estimates peg the probability of success of troriluzole for SCA at 50% in the U.S. and 46.7% globally. Biohaven plans to seek FDA approval for its drug candidate in Q4 2024 and, with Priority Review for troriluzole, aims to launch it in the U.S. by 2025. Regulatory review is already underway in the EU. Once approved, troriluzole is projected to generate $17 million in risk-adjusted revenue in 2025, accounting for an estimated 56% of the company’s total revenue. By 2035, troriluzole risk-adjusted revenues are expected to rise to $613 million, however, share of total revenue is estimated to fall to 13%. Biohaven is also testing troriluzole for obsessive-compulsive disorder (OCD), with interim and topline data from phase 3 trials expected soon. Analysts estimate potential risk-adjusted revenues of $18 million for troriluzole in OCD by 2026, with a probability of success of 47%.