TherapeuticsMD Submits NDA to FDA, Shares Jump

TherapeuticsMD Inc (NASDAQ: TXMD) rose in Friday trading after the company reported the submission of New Drug Application for TX-001HR to the U.S. Food and Drug Administration.

The company, based in Boca Raton, Florida, filed the application for approval of TX-001HR, the company’s investigational bio-identical hormone therapy combination of estradiol and progesterone in a single, oral softgel for the treatment of moderate-to-severe vasomotor symptoms due to menopause.

A news released put out Thursday indicates that the NDA submission is supported by the complete TX-001HR clinical program, including positive results of the recently completed phase 3 Replenish Trial.

The Company expects to learn of the acceptance of the NDA upon receipt of the Filing Review Notification from the FDA, approximately 74 days after the NDA submission.

TherapeuticsMD, Inc. is an innovative healthcare company focused on developing and commercializing products exclusively for women. With its SYMBODA™ technology, TherapeuticsMD is developing advanced hormone therapy pharmaceutical products to enable delivery of bio-identical hormones through a variety of dosage forms and administration routes.

The Company also manufactures and distributes branded and generic prescription prenatal vitamins under the vitaMedMD® and BocaGreenMD® brands.

The company’s late stage clinical pipeline includes two phase 3 product candidates: TX-001HR and TX-004HR for treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause.

The company’s stock gained 17 cents Friday morning, or 2.9%, to $6.10, within a 52-week trading range of $3.50 to $8.30.