Key Points
A top regulator said it wouldn’t convene an advisory committee to discuss the biotech’s latest application.
This is for the company’s leading pipeline drug, troriluzole.
10 stocks we like better than Biohaven ›
On a very good Friday for the stock market, Biohaven‘s (NYSE: BHVN) performance was exceptional. The clinical-stage biotech’s share price inflated by over 6% that trading session thanks to regulatory news it delivered in the morning. Even the surging S&P 500 index couldn’t come close to that kind of increase, with its 1.5% gain on the day.
Regulatory progress
Biohaven revealed in a filing with the Securities and Exchange Commission (SEC) that it has been updated on the progress of its New Drug Application (NDA) for troriluzole. The company said that the Food and Drug Administration (FDA) informed it that an advisory committee meeting to discuss the submission at the regulator was no longer necessary.
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.
Troriluzole is a drug that targets spinocerebellar ataxia, a cluster of inherited and progressive neurological disorders that affect the body’s movement. The development and regulatory application process for the drug has been halting, with the FDA initially refusing to accept the company’s filing. Biohaven ran a new late-stage clinical trial and is using its data for the current NDA.
Although the cancellation of the advisory meeting implies the regulator has, in effect, already reached a decision, it might not necessarily be one favorable to the company. Investors are best advised to wait until the actual decision is rendered to make a decision on whether or not to buy this stock.
Good chance for success, apparently
Having said that, according to research from RBC Capital Markets analyst Leonid Timashev cited by Investor’s Business Daily, around two-thirds of applications where an advisory committee meeting is cancelled ultimately won approval (from 2019 until the present). Given that, the market’s very bullish reaction to the news is understandable.
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 $650,499!* Or when Nvidia made this list on April 15, 2005… if you invested $1,000 at the time of our recommendation, you’d have $1,072,543!*
Now, it’s worth noting Stock Advisor’s total average return is 1,045% — a market-crushing outperformance compared to 182% for the S&P 500. Don’t miss out on the latest top 10 list, available when you join Stock Advisor.
See the 10 stocks »
*Stock Advisor returns as of August 18, 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.
