TherapeuticsMD met with FDA officials one month ago but is still waiting for a resolution to the agency’s rejection of its estrogen therapy for postmenopausal women known as TX-004HR. The “regulatory update” announced Monday with no clear plan forward was not well received by investors. TherapeuticsMD shares are down 11 percent.

TX-004HR is a capsule filled with estradiol (bioidentical estrogen) that menopausal women insert into their vaginas to deal with the bothersome vaginal changes — dryness, itching, pain during sex — that can occur when the body’s own estrogen levels fall.

Unlock this article by subscribing to STAT Plus and enjoy your first 30 days free!

GET STARTED

What is it?

STAT Plus is a premium subscription that delivers daily market-moving biopharma coverage and in-depth science reporting from a team with decades of industry experience.

What's included?

  • Authoritative biopharma coverage and analysis, interviews with industry pioneers, policy analysis, and first looks at cutting edge laboratories and early stage research
  • Subscriber-only networking events and panel discussions across the country
  • Monthly subscriber-only live chats with our reporters and experts in the field
  • Discounted tickets to industry events and early-bird access to industry reports

Leave a Comment

Please enter your name.
Please enter a comment.

Sign up for our Daily Recap newsletter

A roundup of STAT’s top stories of the day in science and medicine

Privacy Policy