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TherapeuticsMD's (TXMD) ACOG Meeting Presentation Encouraging; Noble Financial Affirms 'Buy' Rating

May 29, 2015 8:29 AM EDT
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Price: $2.29 +1.78%

Rating Summary:
    10 Buy, 4 Hold, 1 Sell

Rating Trend: = Flat

Today's Overall Ratings:
    Up: 13 | Down: 11 | New: 11
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Noble Financial affirms TherapeuticsMD, Inc. (NYSE: TXMD) at Buy with a price target of $15 following the company's recent presentation at the 63rd Annual Clinical and Scientific American College of Obstetricians and Gynecologist 2015 (ACOG) meeting.

Analyst Nathan Cali noted the following key points from the presentation:

  • The study set out to measure annual disease incidence between the years 2006 through 2012 among women 46 years and older using topical unopposed estrogen, women who used systematic (oral) estrogen's were excluded from the study
  • Incidence rates; 9.96, 10.25 and 9.96 per 10,000 women, in women that received >4 prescriptions, 1-3 prescriptions or no prescriptions, respectively; indicating that unopposed topical vaginal estrogen not associated with increased cancer risk
  • Importance of data; upon approval VagiCap lowest effective dose topically delivered estrogen (4mcg), data supports position for potential labeling change, VagiCap 10mcg (PK) showed signifacntly lower circulating estrogen compared to Vagifem, the RLD
  • Specifically the FDA has suggested that there is an increased risk of endometrial cancer in women with a uterus who use unopposed estrogen, although this study was limited by retrospective data, it contradicts the box warning from the FDA

Cali also offered the following commentary: The data presented at ACOG is encouraging for the safety profile of topically delivered estrogens. Dr. Gunnison from the Kaiser Permanente Center in Santa Clara California, who presented the results, indicated the importance of this data, since women choose to use topical estrogens because of concerns around potential adverse events from systematic estrogens. Locally acting estrogen products administered intravaginally are not intended to deliver higher levels of blood concentrations. Estrogen drug products are well absorbed through the skin, mucous membranes. The vaginal delivery of estrogens circumvents first-pass metabolism and potential systematic effects of circulating estrogens. In our view further validation from the scientific community expands the opportunity for TherapeuticsMD VagiCap soft gel formulation, and even possibly the removal or adjustment to the black box labeling for topically delivered estrogens. The company plans to present data from a 4mcg dose before the end of 2015 and if successful could provide the lowest effective approved dose of locally delivered estrogen.

For an analyst ratings summary and ratings history on TherapeuticsMD click here. For more ratings news on TherapeuticsMD click here.



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