TherapeuticsMD Inc (NYSEMKT: TXMD) is off to an incredibly rough start in the pre-market hours this morning, and for good reason. The company provided an update with regard to their activity with the United States Food and Drug Administration surrounding TX-004HR. Unfortunately, the update simply wasn't what investors were expecting. In fact, Adam Feuerstein tweeted that the “update didn't read well.” As a result, fear struck investors, leading to declines in the value of the stock and prompting our friends at Trade Ideas to alert us to the movement. At the moment (8:50), TXMD is trading at $5.00 per share after a loss of $0.63 per share (11.19%) thus far today.
TXMD Provides Regulatory Update
As mentioned above, TherapeuticsMD issued a PR today, updating investors with regard to conversations it's having with the FDA surrounding TX-004HR. TX-004HR is the company's investigational applicator-free estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse.
In the PR, TXMD said that it participated in a Type A Post-Action Meeting with the Division of Bone, Reproductive, and Urologic Products of the United States Food and Drug Administration on Friday. The purpose of the meeting was to discuss the Complete Response Letter, or simply CRL, that was received surrounding the treatment. Through the meeting, TXMD said that it had presented new information that they believe could address concerns by the FDA in the CRL and possibly help to push TX-004HR to NDA approval.
In the PR, investors learned that TherapeuticsMD has received the minutes of the meeting, and upon the request of the FDA, has formally submitted the new information for consideration. The PR goes on to explain that productive dialogue is continuing with the FDA but there has not been a formal timeline offered with regard to the conclusion of the review. However, the most interesting line in the TXMD PR reads as follows:
“The Company looks forward to working with the FDA to address its concerns regarding the NDA for TX-004HR and reserves the right to pursue the FDA's formal dispute resolution process if a reasonable timeline to address such concerns cannot be established.”
With the line above, Feuerstein may have hit the nail on the head. The PR reads like there may be a hefty debate surrounding the TXMD CRL, one that could be a signal that the treatment isn't going to be approved, or at least isn't going to be approved any time soon.
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What We'll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on TXMD. In particular, we're interested in following the company through the process of working to get TX-004HR to market. While things don't look so great right now, anything can happen moving forward. We'll continue to follow the story closely and bring the news to you as it breaks!
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