Notable Calls reports that, according to Goldman Sachs, 70 members of Congress (mostly female) have sent a letter to the FDA emphasizing their support for increasing patient access to TherapeuticsMD's (TXMD -2.2%) Yuvvexy (estradiol softgel capsule) for the potential treatment of women with moderate-to-severe dyspareunia (vaginal pain during intercourse).
According to sell-side shop Jefferies, more patients will have access to the product, once approved, if the Black Box warning is removed from the label, a realistic objective considering the low-dose non-systemic estradiol formulation in the product. Jefferies believes this would expand the available market to 32M from 8M.
The company's marketing application is currently under FDA review with an action date (PDUFA) of May 7, 2017.
Previously: TherapeuticsMD's TX-004 HR successful in late-stage trial in dyspareunia (Dec. 7, 2015)