Sage Therapeutics stock plunges 48% after FDA decision on postpartum depression drug

Shares of Sage Therapeutics fell astir 50% connected Monday aft the Food and Drug Administration approved the biotech company's oral cause Zuranolone for postpartum depression, but not for major depressive disorder, a bigger imaginable market.

Shares of Biogen, which jointly developed the attraction with Sage, were astir flat.

The FDA's support precocious Friday made Zuranolone the archetypal oral attraction for postpartum depression, a communal complication that affects 1 successful 8 women during and aft gestation and hinders their quality to relation normally.

The 2 companies besides applied for support of Zuranolone for large depressive disorder, besides known arsenic objective depression. But the FDA said they did not supply capable grounds of the drug's effectiveness successful treating the condition, which affects a overmuch larger colonisation of patients.

Clinical slump affects astir 17.3 cardinal American adults, oregon astir 7% of the radical ages 18 and older, successful a fixed year.

Zuranolone had the imaginable for $1 cardinal successful highest sales, compared with $250 cardinal to $500 cardinal for postpartum depression, Jefferies expert Michael Yee said successful a probe enactment Sunday.

He said objective slump "was truly the large upside operator here" for the companies, portion postpartum slump is "much smaller and whitethorn not beryllium hugely profitable."

Wells Fargo expert Mohit Bansal besides said the objective slump marketplace contributed to 85% of the firm's aboriginal income estimates for Zuranolone. But "there could beryllium a metallic lining arsenic the pricing powerfulness whitethorn beryllium higher" successful postpartum depression, helium wrote successful a Sunday probe note. 

Sage and Biogen person not disclosed Zuranolone's terms for postpartum slump treatment.

The FDA said further studies mightiness beryllium required to enactment the drug's support for objective depression. 

But Yee noted that Biogen is improbable to "quickly determination guardant connected different late-stage study" connected the cause for objective slump since the institution is focusing connected saving costs and precocious announced layoffs.