TherapeuticsMD Inc. shares dropped 7% in premarket trade on Wednesday after the company said the Food and Drug Administration will re-review its therapy by the end of May. The FDA classified the resubmission as a “class 2 response” rather than a class 1 response, giving it a longer timeline for FDA review, because “the additional endometrial safety information submitted to the [New Drug Application] for TX-004HR on September 14, 2017 was outside of an official review cycle.” If the therapy is approved according to the FDA’s timeline, TherapeuticsMD said it plans a launch in the third quarter of 2018, which could be as early as July 2018. “The wait continues,” said Stifel analyst Annabel Samimy, who had previously expected a class 1 review, which has a two-month timeline (relative to a class 2 review’s six-month timeline), adding “we continue to believe in the approvability of TX-004HR.” TX-004HR is intended to treat pain during sexual intercourse that is caused by a symptom of menopause. The FDA previously failed to approve the therapy in May, citing a need for more long-term safety data. Company shares have declined 2% over the last three months, compared with a nearly 7% rise in the S&P 500 and a 10.5% rise in the Dow Jones Industrial Average .
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