What happened
After providing investors with a regulatory update, shares of TherapeuticsMD (TXMD) 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."
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.
