No ad com suggests positive potential outcome for Sage’s zura, says BofA

BofA analyst Tazeen Ahmad notes that Sage Therapeutics (SAGE) and partner Biogen (BIIB) announced that the FDA is not planning to hold an advisory committee, or ad com, in relation to zuranolone’s application review, which the analyst says suggests a positive potential outcome. Zura is currently being reviewed by the agency under priority review for approval in PPD and MDD with a PDUFA action date of August 5, notes the analyst, who was "not surprised by the update," but always assumed the possibility of an ad com given the "relatively moderate benefit" seen in the phase 3 WATERFALL trial in MDD. The analyst, who notes that Sage is its top small cap pick of the year, maintains a Buy rating and $55 price target on the shares ahead of zura’s PDUFA outcome.