Last Friday, TherapeuticsMD Inc (NASDAQ:TXMD) met with the FDA to discuss next steps in the review of the company’s TX-004 New Drug Application (NDA) for vulvar vaginal atrophy (VVA). Today, as part of its earnings announcement, TherapeuticsMD disclosed the meeting outcome/plans. The company said the FDA has agreed to the resubmission of the NDA without the need for an additional pre-approval study, sending shares up nearly 35% (as of this writing).
Cantor analyst William Tanner commented, “Based on the recent meeting with the FDA, we believe TX-004 is clearly on the path to approval and believe it will be an important new treatment for vulvar vaginal atrophy (VVA). We believe investor confidence in the viability of the entire enterprise, not just the asset, should increase with today’s announcement. We believe 2018 is setting up to be an important year for the company with two FDA approvals possible and the launch of a major product likely.”
“Notwithstanding today’s positive announcement, we are mindful that some investors may have had less-than-satisfying experiences with the stock. At the current market valuation, our model implies a forecast for TX-004 sales of approximately $200 million, as compared to our forecast of $900 million,” the analyst added.
As such, Tanner reiterates an Overweight rating on TXMD shares, with a $32 price target, which implies an upside of nearly 450% from current levels.
Wall Street agrees with Tanner that this biotech firm is one to watch, as TipRanks analytics exhibit TXMD as a Strong Buy. Out of 6 analysts polled in the last 3 months, 5 are bullish on TherapeuticsMD stock while 1 remains sidelined. With a return potential of 162%, the stock’s consensus target price stands at $15.50.
TherapeuticsMD is a healthcare company, which focuses on developing and commercializing products for women. Its technology, SYMBODA, develops advanced hormone therapy pharmaceutical products to enable delivery of bio-identical hormones through a variety of dosage forms and administration routes. The company also manufactures and distributes branded and generic prescription prenatal vitamins, as well as over-the-counter vitamins under the vitaMedMD and BocaGreenMD brands.