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[usasingh1]

$TXMD In July, TherapeuticsMD submitted a New Drug Application with the FDA for Yuvvexy, the conditionally approved trade name for TX-004HR, the company’s applicator-free vaginal estradiol softgel drug candidate for the treatment of moderate- to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy due to menopause. The NDA is supported by the complete Yuvvexy clinical program, including positive results of the recently completed phase 3 Rejoice Trial. The submission included all three doses of Yuvvexy (4 mcg, 10 mcg and 25 mcg) that were evaluated in the Rejoice Trial. Based on a traditional FDA timeline, the company should hear back by September 7th on whether the agency will reject or accept the application for review. Separately, the company anticipates 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