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TherapeuticsMD Submits NDA for VMS Candidate, Shares Rise

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Shares of TherapeuticsMD, Inc. (TXMD - Free Report) were up 4.4% in after-market trading on Dec 28, following the submission of a new drug application (“NDA”) to the FDA for pipeline candidate, TX-001HR.

In fact, TherapeuticsMD’s share price has increased 12.5% in the past six months, outperforming the industry’s gain of 5.4%.

The NDA includes data from successfully completed pivotal phase III Replenish study. The study evaluated TX-001HR, a bio-identical hormone therapy combination of estradiol and progesterone, in post-menopausal women who suffer from moderate-to-severe vasomotor symptoms (“VMS”).

Data from the study showed that TX-001HR achieved statistically significant and clinically meaningful reduction in frequency and severity of VMS (hot flashes) from baseline compared to placebo.

TX-001HR is the first investigational bio-identical combination hormone therapy of estradiol and progesterone. The company believes there is significant demand for a bio-identical hormone therapy for treating VMS, which is currently being treated with unapproved combinations made by independent and community pharmacies.

A potential approval to TX-001HR will help patients to use proven safe and effective treatment and the cost may also get reimbursed through insurance.

The company expects a decision from the FDA on the acceptance of the NDA by March 2018.

We remind investors that last week, the FDA also accepted TherapeuticsMD’s resubmission of the NDA for TX-004HR seeking approval to treat dyspareunia. A decision is expected in May 2018.

The company currently earns from manufacture and distribution of branded and generic prescription prenatal vitamins.  Approval of the NDAs will likely boost the company’s revenues.

Zacks Rank & Stocks to Consider

TherapeuticsMD carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the pharma sector include Celldex Therapeutics, Inc. (CLDX - Free Report) , ACADIA Pharmaceuticals Inc. (ACAD - Free Report) and Corcept Therapeutics Inc. (CORT - Free Report) . All the stocks carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Celldex’s loss estimates narrowed from $1.03 to 93 cents for 2017 and from 96 cents to 90 cents in the last 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 15.36%.

ACADIA’s loss estimates narrowed from $2.42 to $2.41 for 2017 and from $1.62 to $1.59 in the last 30 days. The company came up with a positive earnings surprise in three of the trailing four quarters with an average beat of 9.95%. The company’s shares have returned 5.7% so far this year. The stock is up 8.1% so far this year.

Corcept’s earnings per share estimates have increased from 78 cents to 88 cents for 2018 over the last 60 days. The company delivered a positive earnings surprise in two of the trailing four quarters with an average beat of 14.32%. The stock is up 150.2% so far this year.

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