Biohaven Stock Spikes After Drug Candidate To Treat Rare Neurodegenerative Disease Shows Promise

Monday, Biohaven Ltd. BHVN released topline results from pivotal Study BHV4157-206-RWE demonstrating the efficacy of troriluzole on the mean change from baseline in the f-SARA after three years of treatment.

The study achieved the primary endpoint and showed statistically significant improvements on the f-SARA at years 1 and 2.

Spinocerebellar Ataxia (SCA) is a rare neurodegenerative disease. It affects approximately 15,000 people in the U.S. and 24,000 in Europe and the U.K.

Also Read: Biohaven Stock Stumbles As Protein-Degrading Drug Falls Short Of Expectations In Early-Stage Study.

There are no FDA-approved treatments for SCA.

Data across multiple analyses demonstrate a robust and clinically meaningful slowing of disease progression in SCA patients.

These treatment benefits translate into a 50-70% slower rate of decline compared to untreated patients. They represent a 1.5-2.2 years delay in disease progression over the three-year study period.

Disease progression showed an odds ratio (OR) of 4.1 for the untreated external control arm versus troriluzole-treated subjects.

The primary objective was to examine the treatment effects of troriluzole for up to three years.

Troriluzole-treated patients demonstrated statistically significant and sustained benefits at years 1, 2 and 3 on the f-SARA compared to a rigorously matched natural history control.

Biohaven plans to submit a New Drug Application (NDA) to the FDA in the fourth quarter of 2024.

The troriluzole development program has generated the largest clinical trial dataset in SCA and now has a follow-up in some patients treated with troriluzole for over five years.

Biohaven will be prepared to commercialize SCA in the U.S. in 2025, if ultimately approved, based on potential priority review timelines.

Price Action: Biohaven stock is up 12% at $45.20 during the premarket session at last check Monday.

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