TherapeuticsMD Inc (NASDAQ: TXMD) is having a great start to the trading session after announcing that it has received news of an approval from the United States Food and Drug Administration. Of course, this means that the company is now able to move to commercialization of the treatment, exciting investors and sending the stock toward the top. Today, we’ll talk about:
- The approval;
- what we’re seeing from the stock as a result;
- and what we’ll be watching for with regard to TXMD ahead.
TXMD Announces FDA Approval
As mentioned above, TherapeuticsMD is having an incredibly strong start to the trading session this morning after announcing United States Food and Drug Administration (FDA) approval. In a press release issued this morning, the company announced that the FDA has approved IMVEXXY (estradiol vaginal inserts). The treatment has been approved for the indication of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity. In the release, TXMD said that the condition is a symptom of vulvar and vaginal atrophy (VVA) as a result of meopause. Currently, IMVEXXY is the only product in its class to offer a 4 mcg and 10 mcg dose. In fact, the 4 mcg dose currently represents the lowest approved dose of vaginal estradiol on the market.
In a statement, Brian Bernick, MD, Chief Clinical Officer at TXMD, had the following to offer:
IMVEXXY is a bio-identical vaginal estrogen product that offers a fraction of the estrogen contained in the average doses of many existing products currently on the market… IMVEXXY is the only product specifically designed to be applicator-free. It dissolves completely without mess or additional clean-up, and can be used anytime of day. It allows women the freedom to immediately return to their normal daily activities. Studies showed that, in patients who used IMVEXXY, systemic absorption of estradiol remained within postmenopausal range.
The above statement was followed up by Robert Finizio, Chief Executive Officer at TXMD. Here’s what he had to offer:
We are excited to bring IMVEXXY to market as TherapeuticsMD’s first FDA-approved drug as we strive to be the premier Women’s Health Company… IMVEXXY reflects our long-standing corporate mission and commitment to health solutions that women want, based on the concepts of medical need, efficacy, safety, simplicity, and affordability. IMVEXXY will be offered at a price in parity with other products that have been on the market for 10 to 30 years. By ensuring patients can access IMVEXXY at an affordable price, TherapeuticsMD is doing the right thing for women.
What We’re Seeing From The Stock
As investors, one of the first lessons that we learn is that the news moves the market. In this particular case, the news proved to be overwhelmingly positive. After all, TherapeuticsMD now has an FDA approved product that it can move into commercial stages, generating revenue as a result. So, it’s no surprise to see that excited investors are sending the stock on a run for the top. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:36), TXMD is trading at $6.70 per share after a gain of $0.27 per share or 4.20% thus far today.
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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 commercialization of IMVEXXY as it now has the approval to move forward with marketing. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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