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TherapeuticsMD Comments on Media Reports Regarding TX-004HR


TherapeuticsMD, Inc. (NASDAQ:TXMD), an innovative women's healthcare
company, today commented on media reports that TX-004HR, the company's
investigational applicator-free estradiol vaginal softgel capsule for
the treatment of moderate-to-severe vaginal pain during sexual activity
(dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to
menopause, has been approved by the U.S. Food and Drug Administration

As previously announced, the New Drug Application (NDA) for TX-004HR has
a Prescription Drug User Fee Act (PDUFA) target action date of May 29,
2018. Contrary to media reports, the Company has not been informed by
the FDA about the review status of the NDA. The Company anticipates FDA
action will occur on the scheduled PDUFA target action date and will
announce such action at that time.

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 late stage clinical pipeline includes two product
candidates that have completed phase 3 trials and are awaiting approval
by the FDA: TX-001HR for treatment of moderate-to-severe vasomotor
symptoms (VMS) due to menopause and TX-004HR for treatment of
moderate-to-severe vaginal pain during sexual activity (dyspareunia), a
symptom of vulvar and vaginal atrophy (VVA) due to menopause. The
Company also manufactures and distributes branded and generic
prescription prenatal vitamins under the vitaMedMD® and BocaGreenMD®

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 resolve the deficiencies
identified by the FDA in the company's new drug application for its
TX-004HR product candidate and the time frame associated with such
resolution; whether the FDA will approve the amended NDA for the
company's TX-004HR product candidate and whether such approval will
occur by the PDUFA target action date; whether the FDA will approve the
NDA for the company's TX-001HR product candidate and whether such
approval will occur by the PDUFA target action date; 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; whether the company
be able to comply with the covenants and conditions under its term loan
agreement; the length, cost and uncertain results of the company's
clinical trials, including any additional clinical trials that the FDA
may require in connection with TX-004HR; 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 website:

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