Fly News Breaks for December 1, 2016
TXMD
Dec 1, 2016 | 09:51 EDT
Jefferies analyst Matthew Andrews noted that the Congressional Caucus for Women's Issues has urged the FDA to reconsider labeling of low-dose vaginal estrogen therapy for vulvovaginal atrophy and that the FDA is "clearly committed" to potentially amend their labels. A label without the warnings would be a "game-changer" for TherapeuticsMD's Yuvvexy, expanding its market to 32M women from 8M, and the drug is uniquely positioned to potentially be the first to receive such a "clean label," said Andrews, who keeps a Buy rating on the stock.
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