- Announced acceptance of a New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA) for TX-004HR (conditionally-approved trade name Yuvvexy™), the company's investigational applicator-free estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause. The NDA is supported by the complete TX-004HR clinical program, including positive phase 3 results with all three doses of TX-004HR (4 mcg, 10 mcg and 25 mcg) that were evaluated in the Rejoice Trial. The FDA's Prescription Drug User Fee Act (PDUFA) target action date for the NDA is May 7, 2017.
- Anticipate topline results in the fourth quarter of 2016 for the ongoing Replenish Trial, a phase 3 clinical trial of the company's TX-001HR product candidate, which, if approved, would be the first and only FDA-approved bio-identical combination of estradiol and progesterone for the treatment of moderate-to-severe vasomotor symptoms due to menopause.
- Net revenue from the company's prescription prenatal vitamin business increased 7 percent to approximately $5.5 million for the third quarter of 2016, compared with approximately $5.2 million for the third quarter of 2015.
- Net loss was approximately $25.0 million for the third quarter of 2016, compared with approximately $19.5 million for the third quarter of 2015.
- Ended the quarter with approximately $147.5 million in cash and no debt.
- Supported nine presentations at annual meetings of the International Menopause Society (IMS) and North American Menopause Society (NAMS), including reports on the positive results from the TX-004HR clinical development program and new data that further identify women's perceptions of VVA and available treatment options.
- Grew the company's intellectual property portfolio to a current total of 149 patent filings, including 82 international filings, with 17 issued U.S. patents.
- Strengthened relationships with medical, pharmacy, patient and industry organizations internationally.
TherapeuticsMD, Inc. (NYSE MKT:TXMD), an innovative women's healthcare company, today announced its third quarter financial results for the quarter ended September 30, 2016. Third Quarter and Recent Developments