What More Can Support Biogen/Sage's Zuranolone Resubmission: Analysts See Uncertain Road Ahead
Portfolio Pulse from Vandana Singh
The FDA approved Sage Therapeutics Inc and Biogen Inc's Zurzuvae for adults with postpartum depression but issued a Complete Response Letter for the New Drug Application for zuranolone for major depressive disorder. Analysts from Wedbush, William Blair, Needham, Truist Securities, and HC Wainwright have expressed concerns about the effectiveness of zuranolone and the potential need for additional studies. Price targets for both companies have been lowered, and SAGE shares are down 52.30%.
August 07, 2023 | 5:44 pm
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NEGATIVE IMPACT
Biogen, in partnership with Sage Therapeutics, received a Complete Response Letter from the FDA for zuranolone for major depressive disorder. Analysts have lowered the price target for Biogen.
The FDA's Complete Response Letter for zuranolone, a drug developed in partnership with Sage Therapeutics, indicates that the drug did not provide substantial evidence of effectiveness for the treatment of major depressive disorder. This has led to a lowered price target for Biogen from analysts.
CONFIDENCE 100
IMPORTANCE 100
RELEVANCE 100
NEGATIVE IMPACT
Sage Therapeutics received a Complete Response Letter from the FDA for zuranolone for major depressive disorder, leading to lowered price targets and a significant drop in share price.
The FDA's Complete Response Letter indicates that zuranolone did not provide substantial evidence of effectiveness for the treatment of major depressive disorder. This has led to lowered price targets from analysts and a significant drop in Sage's share price.
CONFIDENCE 100
IMPORTANCE 100
RELEVANCE 100