Full Press Release Details
TherapeuticsMD, Inc. 8-K
TherapeuticsMD Announces Filing Timeline
for Yuvvexy (TX-004HR) New Drug Application
BOCA RATON, Fla., June 29,
2016 - TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women's healthcare company, announced today that it
expects that the New Drug Application (NDA) for Yuvvexy, the conditionally approved trade name for the Company's TX-004HR
drug candidate, will be submitted to the Food and Drug Administration (FDA) on or before July 15, 2016. The NDA is being finalized
in Electronic Common Technical Document (eCTD) format and will be submitted to the FDA following electronic publishing activities
and technical document validation. Yuvexxy is an applicator-free, vaginal, estradiol softgel capsule being proposed for the
treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA)
due to menopause. TherapeuticsMD completed the phase 3 Rejoice Trial for Yuvvexy in December 2015.
About TherapeuticsMD, Inc.
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's clinical development pipeline includes two phase 3 products. The company also
manufactures and distributes branded and generic prescription prenatal vitamins as well as over-the-counter vitamins under the
vitaMedMD and BocaGreenMD brands.
Forward-Looking Statements
This press release by TherapeuticsMD,
Inc. may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating
to TherapeuticsMD's objectives, plans and strategies as well as statements, other than historical facts, that address activities,
events or developments that the company intends, expects, projects, believes or anticipates will or may occur in the future. These
statements are often characterized by terminology such as "believes," "hopes," "may," "anticipates,"
"should," "intends," "plans," "will," "expects," "estimates,"
"projects," "positioned," "strategy" and similar expressions and are based on assumptions and
assessments made in light of management's experience and perception of historical trends, current conditions, expected future
developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the
date of this press release, and the company undertakes no duty to update or revise any such statements, whether as a result of
new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject
to risks and uncertainties, many of which are outside of the company's control. Important factors that could cause actual
results, developments and business decisions to differ materially from forward-looking statements are described in the sections
titled "Risk Factors" in the company's filings with the Securities and Exchange Commission, including its most
recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K, and include the following:
the company's ability to maintain or increase sales of its products; the company's ability to develop and commercialize
its hormone therapy drug candidates and obtain additional financing necessary therefor; the length, cost and uncertain results
of the company's clinical trials; the potential of adverse side effects or other safety risks that could preclude the approval
of the company's hormone therapy drug candidates; the company's reliance on third parties to conduct its clinical trials,
research and development and manufacturing; the availability of reimbursement from government authorities and health insurance
companies for the company's products; the impact of product liability lawsuits; the influence of extensive and costly government
regulation; the volatility of the trading price of the company's common stock and the concentration of power in its stock
ownership. PDF copies of the company's historical press releases and financial tables can be viewed and downloaded at its
Director of Investor Relations