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TherapeuticsMD wins first US drug approval as FDA green-lights hormone treatment for vaginal pain

Analysts remain bullish about the company’s prospects, including Oppenheimer's Jay Olson

Menopause sign and stethoscope
The FDA's approval is based on the rosy results of a recent Phase 3 clinical study

TherapeuticsMD Inc, the women’s healthcare company, recorded its first US drug approval Wednesday when it announced that the US Food and Drug Administration approved its hormone treatment for vaginal pain brought on by menopause.

Imvexxy is an estrogen-based treatment used to treat vaginal pain, stemming from vaginal atrophy which comes during menopause.

The FDA’s approval of Imvexxy is based on the results of a recent Phase 3 study that evaluated the safety and efficacy of Imvexxy compared to a placebo over 12 weeks. The study demonstrated that Imvexxy provided relief of vaginal pain due to menopause as early as week two for two sets of doses of 4mcg and 10mcg respectively.

The FDA’s approval does come with a catch, however, as Imvexxy will be flagged with a warning for endometrial cancer, cardiovascular disorders, breast cancer and probable dementia.

Trading in TherapeuticsMD’s shares has been wildly volatile today, with investors reversing course after an optimistic pre-market session and sending the group’s shares down 5.9% to US$6.05 in afternoon trade due to the label warning on the drug.

But some research analysts remain quite bullish about the company’s prospects post the FDA’s approval of Imvexxy, which had been rejected by the drug regulator once before.

Oppenheimer analyst remains bullish

In response to the FDA’s approval, Jay Olson, a research analyst with Oppenheimer, argued that Imvexxy is poised to become the treatment of choice for dyspareunia, or vaginal pain often associated with sex.

“We are optimistic about the potential for Imvexxy and raise our probability of success to 100% (from 85%) with peak sales of US$350mln in 2030,” he wrote in a note.

Oppenheimer’s Olson now has an Outperform rating and price target of US$12 on TherapeuticsMD’s stock.

“We see TXMD as an underappreciated asset, and our Outperform rating is based on the potential for the company to successfully penetrate and expand the market for treatment of menopausal symptoms,” Olson added.

Another selling point of Imvexxy is that it works by providing a fraction of the estrogen contained in the average doses of many of the existing treatments. Estrogen exposure levels for a rival treatment Premarin are seventy-five times higher while another drug Estrace reports estrogen levels that are twenty-five times higher, according to Olson of Oppenheimer’s research.

“We are excited to bring Imvexxy to market as TherapeuticsMD’s first FDA-approved drug,” said Robert Finizio, chief executive officer with TherapeuticsMD, in a statement. “Imvexxy will be offered at a price in parity with other products that have been on the market for 10 to 30 years.”

Vulvar and vaginal atrophy affects as many as 32 million postmenopausal women in the US and only about 2.3 million of these women take prescription medicine to handle the pain.

-- Updates share price and adds analyst commentary --

Quick facts: TherapeuticsMD

Price: 1.48 USD

NYSEMKT:TXMD
Market: NYSEMKT
Market Cap: $402.09 m
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