TXMD Surges on Yuvvexy News
TherapeuticsMD's management team met with the FDA last Friday, to discuss the resubmission process for the drug, TX-004HR. The drug, also called Yuvvexy, is a possible treatment for dyspareunia, or moderate-to-severe vaginal pain during sexual intercourse.
The company had previously received a complete response letter, which is the FDA's equivalent of a rejection letter, for Yuvvexy because its application lacked long-term safety data. The resubmission process can be lengthy and expensive, but the stated today that the FDA has agreed to accept Yuvvexy resubmission without the need to run any additional pre-approval studies.
Given the breathe of fresh air, the company plans to move forward with the resubmission process within the coming weeks. If everything goes well, Yuvvexy could be approved within 2-6 months afterward.
TherapeuticsMD reported a net loss for the quarter of $14.7 million, but losses are typically the norm for companies developing drugs until they mature. The good news is the company has over $148 million in cash and no debt.
As far as the market, trading has been somewhat choppy but the bulls are showing continued strength. The Dow is up 18 points to 23,558 while the S&P 500 is gaining 4 points to 2,591. The Nasdaq is higher by 20 points to 6,785 and the Russell 2000 is adding 4 points to 1,499.