Biotech Halted As FDA Panel Considers Postpartum Depression Drug
Summary
XThe FDA seems inclined to approve the postpartum depression treatment, known in studies as brexanolone, RBC Capital Markets analyst Brian Abrahams said in a report to clients."Given the discussion focused more on labeling/monitoring rather than overall benefit/risk, we see a high likelihood of approval, though continue to believe panelists will agree with FDA that home infusion is likely not warranted yet," Abrahams said Friday.Raymond James analyst Laura Chico noted the FDA "appears slanted toward requiring a health care professional to monitor the entirety of the infusion."While it doesnt necessarily eliminate the possibility of home infusions, the agency indicates primary caregivers are unlikely to be suitable choices," she said in a recent note to clients."Although our Sage valuation is tilted more toward SAGE-217 than Zulresso, we do think this first approval represents an important validation of not only the companys capabilities, but also to build the infrastructure to support SAGE-217 commercialization," she said.