Lawsuit Overview
July 21, 2017 - The case was voluntarily dismissed.
April 17, 2017 - An investor in shares of TherapeuticsMD Inc (NYSEMKT: TXMD) filed a lawsuit in the U.S. District Court for the Southern District of Florida over alleged violations of Federal Securities Laws by TherapeuticsMD Inc in connection with certain allegedly false and misleading statements made between July 7, 2016 and April 9, 2017.
According to the complaint the plaintiff alleges on behalf of purchasers of TherapeuticsMD Inc (NYSEMKT: TXMD) common shares between July 7, 2016 and April 9, 2017, that the defendants violated Federal Securities Laws. More specifically, the plaintiff claims that between July 7, 2016 and April 9, 2017, TherapeuticsMD Inc made false and/or misleading statements and/or failed to disclose that: the Company’s New Drug Application (NDA) submission for TX-004HR was deficient, that the NDA submission for TX-004HR was not supported by the complete TX-004HR clinical program and/or the clinical program was deficient, and that the deficient NDA would likely cause a delay of the FDA’s potential approval of the TX-0004HR NDA.
Boca Raton, FL based TherapeuticsMD Inc is a women's healthcare company engaged in creating and commercializing products for women. TherapeuticsMD Inc is focused on pursuing regulatory approvals and pre-commercialization activities necessary for commercialization of its hormone therapy pharmaceutical products. TherapeuticsMD Inc reported that its annual Total Revenue declined from $20.14 million in 2015 to $19.36 million in 2016 and that its Net Loss increased from $85.08 million in 2015 to $89.88 million in 2016.
On April 10, 2017, TherapeuticsMD Inc announced receipt of a letter from the U.S. Food and Drug Administration (“FDA”stating that its ongoing review of the Company’s New Drug Application (NDA) for TX-004HR has discovered “deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time.