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Tuesday, February 4, 2020
TherapeuticsMD Inc. (TXMD)
Low-dose Bijuva NDA filed, Approval is Anticipated in Q4 2020
(current) TherapeuticsMD, Inc. is a women’s healthcare company focused on developing and commercializing products targeted exclusively for women. It manufactures and distributes branded and generic prescription prenatal vitamins, as well as over-the-counter vitamins and cosmetics, under our vitaMedMD’ and BocaGreenMD’ brands. The company is currently developing advanced hormone therapy pharmaceutical products designed to alleviate the symptoms of and reduce the health risks resulting from menopause-related hormone deficiencies. It is also evaluating various other potential indications for our hormone technology, including oral contraception, preterm birth, vulvar and vaginal atrophy, and premature ovarian failure.
Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Supplement new drug application for Bijuva is submitted. Bijuva is the first and only FDA approved (on October 28 of 2018) hormone therapy of bio-identical estradiol in combination with bio-identical progesterone (P+E, 1 mg/100 mg) for the treatment of moderate to severe vasomotor symptoms due to menopause. The new drug application (NDA) prior-approval efficacy supplement was submitted to the U.S. Food and Drug Administration (FDA) for the lower dose (0.5 mg/100 mg) capsules of Bijuva. The company anticipates a decision by the FDA in Q4 2020. We think this will provide options and dose flexibility for patients.
Commercial uptake continues to grow. The company has three commercial products, all launched within the past 1.5 years. The company is primarily focused on the first commercial product Imvexxy that reached $4.77 mm sales in Q3 2019, while Bijuva and Annovera reached $0.49mm and $0.40mm. We think the product uptake continues to grow for…
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This research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
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