Cantor analyst William Tanner is out with a research note on shares of TherapeuticsMD Inc (NYSEMKT:TXMD), after the company provided an update regarding the New Drug Application (NDA) 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).
Following the presentation of new information (discussed in Type A meeting), TherapeuticsMD has received meeting minutes, and has formally submitted the new information associated with the TX-004HR NDA. The company expects that the new information may be sufficient to address previous concerns raised by the FDA in CRL
Tanner commented, “Until there is clarity as to which path the FDA review of TX-004 will traverse (e.g., “conventional” or dispute resolution), we believe investor interest in TXMD stock could be tepid. Because the only deficiency the FDA identified in the NDA filing was the lack of 12-month endometrial safety data, we believe approval is a matter of when and not if. It matters not, in our opinion, whether FDA failure to ask that 12-month safety study data be included in the filing was an “oversight”, as characterized by TXMD management. The fact that no safety signals have been observed in the AERS database for vaginal estrogen products, according to TXMD, leads us to believe that the FDA (existing review staff or higher-level officials if dispute resolution is pursued) could be comfortable with the conduct of a long-term safety study as part of a post-approval comittment.”
As such, Tanner reiterates an Overweight rating on TherapeuticsMD shares, with a price target of $33, which represents a potential upside of 530% from where the stock is currently trading. (To watch Tanner’s track record, click here)
As of this writing, all the 5 analysts polled by TipRanks (in the past 3 months) rate TherapeuticsMD stock a Buy. With a return potential of 270%, the stock’s consensus target price stands at $19.50.