TherapeuticsMD (NSDQ:TXMD) has submitted its bio-identical hormone therapy to the FDA for approval as a treatment for moderate-to-severe vasomotor symptoms due to menopause.
The company’s investigational combination of estradiol and progesterone is delivered in a single, oral soft-gel capsule.
Shares in TherapeuticsMD fell earlier this month after the company announced that the FDA accepted its resubmitted application for TX-004HR, an applicator-free estradiol vaginal soft-gel capsule for the treatment of dyspareunia.
The company’s shares took a hit presumably because it revealed that its resubmitted application is a Class 2 response. A Class 1 response would have quickened the timeline for potential approval but as a Class 2 response, the FDA can take up to six months to make a decision.
TXMD shares were trading at $6.01 apiece in early morning activity today, up +1.4%.
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