TherapeuticsMD Submits NDA For VMS Candidate, Shares Rise
Zacks Investment Research | Dec 28, 2017 09:55PM ET
Shares of TherapeuticsMD, Inc. (NASDAQ:TXMD) were up 4.4% in after-market trading on Dec 28, following the submission of a new drug application (“NDA”) to the FDA for pipeline candidate, TX-001HR.
In fact, TherapeuticsMD’s share price has increased 12.5% in the past six months, outperforming the industry ’s gain of 5.4%.
The NDA includes data from successfully completed pivotal phase III Replenish study. The study evaluated TX-001HR, a bio-identical hormone therapy combination of estradiol and progesterone, in post-menopausal women who suffer from moderate-to-severe vasomotor symptoms (“VMS”).
Data from the study showed that TX-001HR achieved statistically significant and clinically meaningful reduction in frequency and severity of VMS (hot flashes) from baseline compared to placebo.
TX-001HR is the first investigational bio-identical combination hormone therapy of estradiol and progesterone. The company believes there is significant demand for a bio-identical hormone therapy for treating VMS, which is currently being treated with unapproved combinations made by independent and community pharmacies.
A potential approval to TX-001HR will help patients to use proven safe and effective treatment and the cost may also get reimbursed through insurance.
The company expects a decision from the FDA on the acceptance of the NDA by March 2018.
We remind investors that last week, the FDA also accepted TherapeuticsMD’s resubmission of the NDA for TX-004HR seeking approval to treat dyspareunia. A decision is expected in May 2018.
The company currently earns from manufacture and distribution of branded and generic prescription prenatal vitamins. Approval of the NDAs will likely boost the company’s revenues.
TherapeuticsMD, Inc. Price
Original post
Get The News You Want
Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.