Please ensure Javascript is enabled for purposes of website accessibility

Why Flexion Therapeutics Bolted Higher Today

By George Budwell – Feb 17, 2016 at 10:37AM

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

The biopharma's lead product candidate has bounced back from an earlier clinical setback.

Image source: Flickr user Steven Depolo.

What: Shares of Flexion Therapeutics (FLXN) gained more than 22% in early morning trading today after announcing that its lead drug candidate, Zilretta (FX006), met its primary endpoint in a late-stage trial for moderate to severe osteoarthritis (OA) knee pain. Specifically, at week 12 in a large, randomized study, the drug reportedly generated significant and durable pain relief when pitted against patients taking placebo.  

So what: According to Flexion, Zilretta stands to serve a target market of over 12 million patients in the U.S. alone, implying that the drug has the potential to generate at least several hundred million in peak sales if approved. 

Now what: Based on these highly significant late-stage results, Flexion now plans on submitting a New Drug Application for Zilretta in the second half of 2016. So, with a Fast Track designation from the U.S. Food and Drug Administration in hand, Zilretta could be on the market by early 2017, if all goes as planned.

Having said that, Zilretta's forthcoming regulatory review is far from a slam dunk, given that it missed the same primary endpoint in a smaller mid-stage trial last September. That's why I don't personally plan on picking up any shares of this small-cap biopharma just yet. 

George Budwell has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

Invest Smarter with The Motley Fool

Join Over 1 Million Premium Members Receiving…

  • New Stock Picks Each Month
  • Detailed Analysis of Companies
  • Model Portfolios
  • Live Streaming During Market Hours
  • And Much More
Get Started Now

Stocks Mentioned

Flexion Therapeutics, Inc. Stock Quote
Flexion Therapeutics, Inc.

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

Related Articles

Motley Fool Returns

Motley Fool Stock Advisor

Market-beating stocks from our award-winning analyst team.

Stock Advisor Returns
S&P 500 Returns

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 09/26/2022.

Discounted offers are only available to new members. Stock Advisor list price is $199 per year.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.