Last Thursday, TherapeuticsMD (TXMD) announced that it has entered into discussions with the FDA regarding the proposed label for TX-001, the company’s experimental estrogen plus progesterone (E+P) formulation for the treatment of vasomotor symptoms (VMS) associated with menopause.
Cantor analyst William Tanner sees the announcement as a clear positive and continues to expect TX-001 to be approved on its October 28 PDUFA date. More broadly on TX-001, the analyst sees the product as the largest of the company’s three opportunities with the drug targeting both the traditional, FDA-approved separate estrogen and progesterone market as well as the compounded hormone replacement space.
Tanner wrote, “We met with management and they explained that the labeling disclosure was intended to take the topic off the table for conversations with investors. Because TXMD management seems to be given little benefit of the doubt by the market, we believe that decision makes abundant sense as remaining mum might lead to the possibly erroneous conclusion that the drug is not on track for approval. Management also noted that the announcement carried a disclaimer about no assurance of FDA approval.”
“In our experience, management teams typically eschew commenting on whether such discussions have occurred so as not to create the expectation that approval could occur over the nearer term (usually the PDUFA date). If there is a delay in FDA approval beyond the PDUFA date of October 28, we believe the market’s reaction will be swift and harsh and that management credibility could suffer greatly,” Tanner added.
Net net, Tanner reiterates an Overweight rating on TXMD shares, with a price target of $27, as “3 approvals and ample cash should close out 2018 on a high note.” (To watch Tanner’s track record, click here)
Wall Street agrees with Tanner that this biotech player is one to watch, as TipRanks analytics exhibit TXMD as a Strong Buy. Out of 7 analysts polled in the last 12 months, all 12 are bullish on TherapeuticsMD stock. With a return potential of nearly 170%, the stock’s consensus target price stands at $16.00. (See TXMD’s price targets and analyst ratings on TipRanks)