Shares of TherapeuticsMD, Inc. (TXMD - Free Report) have declined almost 25% since Monday when it received a letter from the FDA identifying deficiencies in the new drug application (NDA) for its dyspareunia drug, TX-400HR filed last July.
The company’s shares have slightly underperformed the Zacks classified Medical – Drugs industry since the beginning of this year. TherapeuticsMD's shares declined 0.4% while the industry was down 0.2% in that period.
TX-400HR is an applicator-free vaginal estradiol softgel drug for the treatment of moderate to severe dyspareunia due to vulvar and vaginal atrophy in post-menopausal women.
Without mentioning the nature of the deficiencies, the agency notified that it is difficult to discuss labeling and post marketing requirements at this time. The FDA accepted the NDA in September last year and set a PDUFA target date of May 7, 2017 with a conditionally-approved trade name, Yuvvexy. At the same time, the FDA set a target date (Apr 9, 2017) when it would discuss proposed labeling and/or post marketing requirements/commitments with the company.
However, the regulatory agency’s inability to discuss any such requirements hints at a possible delay in the approval of the candidate. This probably raised investors' concerns, thereby sending shares down. However, the FDA clarified that this letter is not the final decision on the NDA.
TherapeuticsMD had submitted the NDA based on data from a phase III study Rejoice, which met one of its primary endpoints of statistically significant and clinically meaningful improvements in dyspareunia and vaginal dryness.
The company has another drug in its pipeline, which is being studied in a phase III study for the treatment of moderate-to-severe vasomotor symptoms due to menopause. Also, TherapeuticsMD manufactures and distributes branded and generic prescription prenatal vitamins.
We note that recently AMAG Pharmaceuticals, Inc. (AMAG - Free Report) acquired commercial rights to Intrarosa, the only FDA-approved non-estrogen product for the treatment of moderate-to-severe dyspareunia from privately held Endoceutics, Inc.
Zacks Rank & Stocks to Consider
TherapeuticsMD currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the drug sector include Grifols, S.A. (GRFS - Free Report) and Vertex Pharmaceuticals Incorporated (VRTX - Free Report) . Grifols sports a Zacks Rank #1 (Strong Buy) while Vertex carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Grifols' earnings per share estimates increased from $1.04 to $1.15 for 2017 over the last 60 days. The company’s shares have appreciated 20.3% so far this year.
Shares of Vertex have gained 55.1% this year so far, while the company’s earnings estimates for 2017 went up almost 6% in the past 60 days.
Zacks' Best Private Investment Ideas
While we are happy to share many articles like this on the website, our best recommendations and most in-depth research are not available to the public.
Starting today, for the next month, you can follow all Zacks' private buys and sells in real time. Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors. Click here for Zacks' private trades >>