On this photo illustration, the Sage Therapeutics logo of a biopharmaceutical company seen on a smartphone and on a pc screen.
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Shares of Sage Therapeutics fell greater than 50% on Monday after the Food and Drug Administration approved the biotech company’s oral drug zuranolone for postpartum depression, but not for major depressive disorder, an even bigger potential market.
Shares of Biogen, which jointly developed the treatment with Sage, were up modestly.
The FDA’s approval late Friday made zuranolone the primary oral treatment for postpartum depression, a typical complication that affects 1 in 8 women during and after pregnancy and hinders their ability to operate normally.
The 2 firms also applied for approval of zuranolone for major depressive disorder, also referred to as clinical depression. However the FDA said they didn’t provide enough evidence of the drug’s effectiveness in treating the condition, which affects a much larger population of patients.
Clinical depression afflicts roughly 17.3 million American adults, or about 7% of the people ages 18 and older, in a given yr.
Zuranolone had the potential for $1 billion in peak sales, compared with $250 million to $500 million for postpartum depression, Jefferies analyst Michael Yee said in a research note Sunday.
He said clinical depression “was really the large upside driver here” for the businesses, while postpartum depression is “much smaller and will not be hugely profitable.”
Wells Fargo analyst Mohit Bansal also said the clinical depression market contributed to 85% of the firm’s future sales estimates for zuranolone. But “there might be a silver lining because the pricing power could also be higher” in postpartum depression, he wrote in a Sunday research note.Â
Sage and Biogen haven’t disclosed zuranolone’s price for postpartum depression treatment.
The FDA said additional studies is likely to be required to support the drug’s approval for clinical depression.Â
But Yee noted that Biogen is unlikely to “quickly move forward on one other late-stage study” on the drug for clinical depression for the reason that company is specializing in saving costs and recently announced layoffs.
