FDA Approves Sage Therapeutics/Biogen's Zuranolone For One Type Of Depression, Rejects For Another
Portfolio Pulse from Vandana Singh
The FDA has approved Sage Therapeutics Inc (SAGE) and Biogen Inc's (BIIB) Zurzuvae (zuranolone) 50 mg for adults with postpartum depression (PPD). The drug is the first oral, once-daily, 14-day treatment for PPD and is expected to be commercially available in Q4 2023. However, the FDA rejected the drug for the treatment of adults with major depressive disorder (MDD), stating that additional studies will be needed. The stocks of both companies might fall due to the smaller patient population for PPD.
August 07, 2023 | 12:57 pm
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NEGATIVE IMPACT
Biogen's stock may fall due to the FDA's approval of Zurzuvae for only postpartum depression, which has a smaller patient population.
The FDA's approval of Zurzuvae for only postpartum depression, which has a smaller patient population, may negatively impact Biogen's stock.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100
NEGATIVE IMPACT
Sage Therapeutics' stock may fall due to the FDA's approval of Zurzuvae for only postpartum depression, which has a smaller patient population.
The FDA's approval of Zurzuvae for only postpartum depression, which has a smaller patient population, may negatively impact Sage Therapeutics' stock.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100