TherapeuticsMD, Inc. (NYSEMKT:TXMD) Files An 8-K Regulation FD Disclosure
Item 7.01.
| Regulation FD Disclosure. |
On May 8, 2017, TherapeuticsMD, Inc., a Nevada corporation
(TherapeuticsMD or the “Company”), issued a press release
announcing that the Company received a Complete Response Letter
(CRL) from the U.S. Food and Drug Administration (the FDA)
regarding the Companys New Drug Application (the NDA) for
TX-004HR, the Companys investigational applicator-free estradiol
vaginal softgel 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. A copy of
the press release is furnished as Exhibit 99.1 to this Current
Report on Form 8-K and is incorporated in this Item 7.01 by
reference.
The information in Items 7.01 and 9.01 of this Current Report on
Form 8-K (including the exhibit) is furnished and shall not be
deemed to be filed for the purposes of Section 18 of the
Securities Exchange Act of 1934, as amended (the Exchange Act),
or otherwise subject to the liabilities of that section. The
information in Items 7.01 and 9.01 of this Current Report shall
not be incorporated by reference into any filing under the
Securities Act of 1933, as amended, or the Exchange Act, whether
made before or after the date of this Current Report, regardless
of any general incorporation language in the filing.
| Item 8.01. | Other Events. |
As described above, TherapeuticsMD received a CRL from the FDA
regarding the Companys NDA for TX-004HR, the Companys
investigational applicator-free estradiol vaginal softgel 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.
In the CRL, the only approvability concern raised by the FDA was
the lack of long-term endometrial safety data for TX-004HR beyond
the 12 weeks studied in the pivotal phase 3 Rejoice Trial. No
cases of endometrial hyperplasia were observed in the Rejoice
Trial at the end of week 12 for all the doses studied and
included in the NDA.
The CRL did not identify any issues related to the efficacy of
TX-004HR and did not identify any approvability issues related to
chemistry, manufacturing, and controls.
The Company intends to meet with the FDA as soon as possible to
discuss the concerns raised by the FDA.
This report by TherapeuticsMD, Inc. may contain forward-looking
statements. Forward-looking statements may include, but are not
limited to, statements relating to TherapeuticsMDs 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 managements
experience and perception of historical trends, current
conditions, expected future developments and other factors
believed to be appropriate. Forward-looking statements in this
report are made as of the date of this report, 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 companys 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 companys 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 companys ability to resolve the
deficiencies identified by the FDA in the companys new drug
application for its TX-004HR product candidate and the time frame
associated with such resolution; whether the company will be able
to prepare an amended NDA for its TX-004HR product candidate and,
if prepared, whether the FDA will accept and approve the NDA; the
companys ability to maintain or increase sales of its products;
the companys ability to develop and commercialize its hormone
therapy drug candidates and obtain additional financing necessary
therefor; whether the company will be able to prepare an NDA for
its TX-001HR product candidate and, if prepared, whether the FDA
will accept and approve the NDA; the length, cost and uncertain
results of the companys clinical trials; the potential of adverse
side effects or other safety risks that could preclude the
approval of the companys 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 companys products; the impact
of product liability lawsuits; the influence of extensive and
costly government regulation; the volatility of the trading price
of the companys common stock and the concentration of power in
its stock ownership.
| Item 9.01. | Financial Statements and Exhibits. |
| (d) | Exhibits. |
| Exhibit Number | Description | |||
| 99.1 |
Press Release from TherapeuticsMD, Inc., dated May 8, 2017, entitled TherapeuticsMD Receives Complete Response Letter from FDA for TX-004HR New Drug Application. |
About TherapeuticsMD, Inc. (NYSEMKT:TXMD)
TherapeuticsMD, Inc. is a women’s healthcare company engaged in creating and commercializing products for women. The Company is focused on pursuing regulatory approvals and pre-commercialization activities necessary for commercialization of its hormone therapy pharmaceutical products. Its drug candidates used in clinical trials are designed to alleviate symptoms of and reduce health risks resulting from menopause-related hormone deficiencies, including hot flashes, osteoporosis and vaginal discomfort. With its SYMBODA technology, it is developing hormone therapy pharmaceutical products to enable delivery of bio-identical hormones through dosage forms and administration routes. Its product line includes vitaTrue, vitaPearl, vitaMedMD Plus, vitaMedMD One Prenatal Multivitamin, vitaMedMD Plus Rx Prenatal Multivitamin, vitaMedMD One Rx Prenatal Multivitamin, vitaMedMD Iron 21/7, vitaMedMD Vitamin D3 50,000 IU, BocaGreenMD Prena1 Pearl and BocaGreenMD Prena1 Chew. TherapeuticsMD, Inc. (NYSEMKT:TXMD) Recent Trading Information
TherapeuticsMD, Inc. (NYSEMKT:TXMD) closed its last trading session up +0.16 at 4.67 with 2,926,295 shares trading hands.