Please ensure Javascript is enabled for purposes of website accessibility

Why TherapeuticsMD Inc Is Getting Clobbered

By Brian Feroldi - Updated Jul 17, 2017 at 12:00PM

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

Shares tumble after the company failed to produce upbeat regulatory news.

What happened

After providing investors with a regulatory update, shares of TherapeuticsMD (TXMD -1.09%) swooned 10% as of 11:22 a.m. EDT on Monday.

So what

Management at the women's health company told investors that it has received the minutes from its recent meeting with the FDA where it formally discussed the resubmission process for TX-004HR, the company's hopeful treatment for dyspareunia. During its meeting, the company shared additional information with the FDA that they hoped would alleviate the agency's concerns raised in their rejection letter. As a result, many investors were hoping that the company would be able to provide a formal timeline for next steps in this update.

Unfortunately, investors learned today that the FDA is still not willing to provide the company with a formal timeline for the drug's resubmission. However, management did share that it "expects to have additional clarity on the pathway forward for the NDA for TX-004HR in the coming weeks."

the waiting game continues.

Image source: Getty Images.

Traders are viewing this update as bad news and are selling off shares today as a result. That negative view makes sense since just a few days ago, shares rose by double-digits after an analyst upgraded the stock to outperform based on the belief that this meeting with the FDA would result in a quick turnaround time for resubmission. 

Now what

There's not much that long-term investors can do at this point beyond simply continuing to wait for yet another update from the company. Since the FDA's rejection of TX-004HR had nothing to do with the drug's chemistry, efficacy, or manufacturing, there is still ample reason to believe that it is only a matter of time before TherapeuticsMD can resolve this issue and move forward. However, how long that process might take is still anyone's guess. For that reason, I'm content to keep my money invested elsewhere while we wait for this drama story to continue to unfold. 

Brian Feroldi has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. 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

TherapeuticsMD, Inc. Stock Quote
TherapeuticsMD, Inc.
$9.05 (-1.09%) $0.10

*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 08/11/2022.

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.