TherapeuticsMD Inc (NASDAQ: TXMD) shares were fairly flat Friday, after the company reported the Food and Drug Administration’s acceptance of a New Drug Application for TX-001HR.
The company, based out of Boca Raton, Florida, touted TX-001HR as the company’s investigational bio-identical hormone therapy combination of estradiol and progesterone in a single, oral softgel for the treatment of moderate-to-severe vasomotor symptoms due to menopause.
The FDA in its 74-day letter stated that the application is sufficiently complete to permit a substantive review and that, at this time, the FDA has not identified any potential review issues.
The FDA noted that the filing review is only a preliminary evaluation of the application and is not indicative of deficiencies that may be identified during the FDA’s review. The PDUFA target action date for the completion of the FDA's review is October 28.
“The acceptance of the NDA for TX-001HR is another important milestone for TherapeuticsMD and reaffirms the strength and commitment of our organization,”said TherapeuticsMD CEO Robert G. Finizio.
“If approved, TX-001HR has the potential to be the first and only combination of bio-identical estradiol and bio-identical progesterone in a single, oral softgel to meet the needs of patients, physicians, and pharmacies as an FDA-approved, third-party reimbursed treatment option for women suffering from moderate-to-severe vasomotor symptoms due to menopause.”
The shares were unchanged not long before Friday’s closing bell at $5.38, within a 52-week trading range of $3.50 to $8.30
