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TherapeuticsMD’s Rejoice Study Data Published in Journal


TherapeuticsMD, Inc. TXMD announced the publication of two manuscripts detailing with the results of the company’s pivotal phase III study (Rejoice) in Menopause: The Journal of The North American Menopause Society.

TherapeuticsMD’s share price has declined 27.3% in the past one year, while the Zacks classified Medical-Drugs industry declined 10.3%.

The randomized, controlled phase III study was conducted to evaluate the safety and efficacy of one of its lead pipeline candidate, TX-004HR, in postmenopausal women suffering from moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar vaginal atrophy (VVA). The study assessed the effect of three doses of TX-004HR (4 mcg, 10 mcg and 25 mcg) compared to placebo from baseline to week 12.

Both the manuscripts reviewed the positive TX-004HR data across all pre-specified primary and secondary endpoints in the study, along with data from a pharmacokinetic sub-study illustrating the low systemic absorption of TX-004HR. The candidate was found to be well-tolerated with a favorable safety profile. No clinically significant differences in adverse events were observed between treatment and placebo groups.

We note that TX-004HR is currently FDA review with a response expected by May 7, 2017. Approval would be a big boost for the company.
According to the press release issued by the company, an estimated 32 million women are currently suffering from symptoms of VVA in the U.S., and only 2.3 million (7%) are presently being treated with prescription therapy.

Zacks Rank & Key Picks

TherapeuticsMD currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include Sucampo Pharmaceuticals, Inc. SCMP, Epizyme, Inc. EPZM and Kite Pharma, Inc. KITE. While Sucampo sports a Zacks Rank#1 (Strong Buy), Epizyme and Kite Pharma hold a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Sucampo’s earnings estimates were stable at $1.22 for 2016, but have increased from $1.58 to $1.74 for 2017 over the last 60 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 35.55%.

Kite Pharma’s loss estimates narrowed 2.1% and 0.2% in 2016 and 2017, respectively over last 60 days. The company posted a positive surprise in two of the four trailing quarters, with an average beat of 7.89%.

Epizyme’s loss estimates narrowed 3% and 2.4% in 2016 and 2017, respectively over last 60 days. The company posted a positive surprise in the trailing four quarters, with an average beat of 14.03%. Its share price was up 11.9% in the past one year.

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