TherapeuticsMD, Inc

Robbins Arroyo LLP: TherapeuticsMD, Inc. (TXMD) Misled Shareholders According to a Recently Filed Class Action

Robbins Arroyo LLP announces that a class action complaint was filed against TherapeuticsMD, Inc. (NYSE MKT: TXMD) in the U.S. District Court for the Southern District of Florida. The complaint is brought on behalf of all purchasers of TherapeuticsMD securities between July 7, 2016 and April 9, 2017, for alleged violations of the Securities Exchange Act of 1934 by TherapeuticsMD’s officers and directors. TherapeuticsMD operates as a women’s health care product company. One of the company’s lead product candidates is known as TX-004HR.

TherapeuticsMD Accused of Misleading Investors About Its Clinical Program

According to the complaint, on July 7, 2016, the company announced that it had filed its New Drug Application (“NDA”) for TX-004HR with the U.S. Food and Drug Administration (“FDA”) seeking approval of TX-004HR for the treatment of moderate to severe dyspareunia. The company subsequently stated that it was making excellent progress and that it was encouraged by its positive pivotal Phase 3 Rejoice Trial designed to assess the safety and efficacy of TX-004HR. The complaint alleges that the company failed to inform investors that its NDA submission was deficient and was not supported by the complete TX-004HR clinical program, which would likely cause a delay of the FDA’s potential approval of the NDA.

On April 10, 2017, TherapeuticsMD issued a press release revealing that, as part of its ongoing review of the NDA, the FDA “identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time.” The company further stated that the letter did not specify the deficiencies and that the company was not aware of the nature of the deficiencies. TherapeuticsMD noted that the FDA had previously set a target date of April 9, 2017, for communicating to the company proposed labeling and postmarketing requirements and commitments. On this news, TherapeuticsMD’s stock fell $1.50 per share, or nearly 20%, to close at $6.20 per share on April 10, 2017.

TherapeuticsMD Shareholders Have Legal Options

Concerned shareholders who would like more information about their rights and potential remedies can contact attorney Leonid Kandinov at (800) 350-6003, or you can complete the form below and we will contact you directly.

 

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