Volatile biotech stock Biohaven (NYSE: BHVN) is prone to sharp movements both up and down. On Thursday, it had one of its down days, with its share price eroding by almost 20% on a development with a top regulator. That was on a day when stocks generally did well, as indicated by the S&P 500 (SNPINDEX: ^GSPC) landing in positive territory with a 0.4% rise.
A regulatory extension
After market close on Wednesday, Biohaven divulged that the U.S. Food and Drug Administration’s (FDA) Division of Neurology 1 is extending the due date for its decision on a very promising pipeline drug developed by the company.
Where to invest $1,000 right now? Our analyst team just revealed what they believe are the 10 best stocks to buy right now. Learn More »
Image source: Getty Images.
Specifically, the FDA unit is extending the Prescription Drug User Fee Act (PDUFA) date for Biohaven’s troriluzole, a treatment that targets brain disorder spinocerebellar ataxia (SCA), by three months. The biotech has formally submitted troriluzole under the FDA’s New Drug Application (NDA) regime, and now expects a decision from the regulator to come in the fourth calendar quarter of this year.
According to the company, the FDA said it required the extra time to conduct a full review of recent Biohaven submissions to the regulator’s information requests. The FDA division also told the company that it aims to hold an advisory committee meeting to discuss the troriluzole application, but no date has yet been set for this.
The next moves belong to the FDA
Many investors consider Biohaven to boast excellent potential with troriluzole, as it targets a rare brain disorder that currently has no treatment. It has been granted fast-track, priority review, and orphan drug designation (ODD) by the FDA, so initially it seemed as if a decision on approval would come soon.
It’s always disappointing when there’s a delay, but until we know more about the regulator’s concerns, it’s hard to gauge the ultimate future of troriluzole. Much will depend on the FDA’s moves in the coming months.
Should you invest $1,000 in Biohaven right now?
Before you buy stock in Biohaven, consider this:
The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Biohaven wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years.
Consider when Netflix made this list on December 17, 2004… if you invested $1,000 at the time of our recommendation, you’d have $620,719!* Or when Nvidia made this list on April 15, 2005… if you invested $1,000 at the time of our recommendation, you’d have $829,511!*
Now, it’s worth noting Stock Advisor’s total average return is 959% — a market-crushing outperformance compared to 170% for the S&P 500. Don’t miss out on the latest top 10 list, available when you join Stock Advisor.
*Stock Advisor returns as of May 12, 2025
Eric Volkman has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.