TherapeuticsMD’s (TXMD) TX-004 Takes a Step Forward to FDA Approval, Says Cantor


TherapeuticsMD (NASDAQ:TXMD) investors have a smile on their faces Wednesday, after the drug maker disclosed that it has entered into negotiations with the FDA regarding the proposed label for TX-004HR, the Company’s investigational applicator-free estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia).

Cantor analyst William Tanner views the disclosure as a tacit sign that the drug will be approved.

As such, Tanner reiterates an Overweight rating on shares of TherapeuticsMD, with a $28 price target, which implies a potential upside of 394% from today’s closing price. (To watch Tanner’s track record, click here)

Tanner wrote, “TXMD’s decision to disclose that the company is in label negotiations with the FDA regarding vulvar vaginal atrophy (VVA) treatment TX-004 is risky, in our view, if the company does not have extreme confidence the drug will be approved on or around the May 29th PDUFA date. The announcement is unconventional, in our view, as companies tend to eschew commenting about such activities so as not to influence investors’ anticipation one way or the other. Notwithstanding data that suggest systemic exposure is absent, at least with the 4mcg and 10mcg doses, we would be surprised if the FDA labels the drug without the estrogen class black box warning. Provision of such a “clean” label would be a major positive for investor sentiment as we believe a perception could arise that the drug could be a dominant commercial force in the VVA market by that differentiation alone.”

Tanner is not the only fan of the biotech company on Wall Street, as TipRanks analytics exhibit TXMD as a Strong Buy. Based on 8 analysts polled in the last 12 months, seven rate a Buy on TherapeuticsMD stock while only one issues a Hold. The 12-month average price target stands at $$15.67, marking a 176% upside.