TherapeuticsMD, Inc. (NASDAQ: TXMD) is a healthcare company that develops and commercialize products exclusively for women. The company is in the development of advanced hormone therapy products that deliver bio-identical hormones through numerous administration techniques.
The company announced that their product candidates, TX-001HR (application submission) and TX-004HR (resubmission) is expected in the short-term future. TX-004HR is the Company’s investigational applicator-free estradiol vaginal soft-gel 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.
“We appreciate the hard work and collaborative effort by the FDA in moving TX-004HR one step closer to approval,” said TherapeuticsMD CEO Robert G. Finizio. “We are extremely pleased with the FDA’s position that an additional pre-approval safety study is no longer necessary for the resubmission of the NDA for TX-004HR.”
“We continue to focus on advancing our pipeline of novel hormone therapies and, if approved, bringing new, differentiated treatment options to women suffering from symptoms of menopause,” said TherapeuticsMD CEO Robert G. Finizio.
Share value of TherapeuticsMD reached an intraday high of $6.85 with over 30 million shares traded. Following the announcement this morning, shares of the company reached a high of $9.46 on pre-market trading.