BofA analyst Geoff Meacham lowered the firm’s price target on Biogen (BIIB) to $290 from $310 and keeps a Neutral rating on the shares after the company and partner Sage Therapeutics (SAGE) announced the FDA approved zuranolone for postpartum depression, or PPD, but also issued a complete response letter for the drug to treat major depressive disorder, or MDD. The FDA said there’s not enough evidence of effectiveness to support the MDD application and that an additional study or studies will be needed, notes the analyst, who also thinks zuranolone’s PPD label including a black box warning and embryo-fetal toxicity warning will “greatly limit patient uptake.” Most investors already anticipated the approval would include PPD only, but the firm expects Biogen shares to face pressure on Monday given the view that the news is “arguably the worst-case scenario.”
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Read More on BIIB:
- Sage sees cash and equivalentes enough to support operations into 2025
- Sage, Biogen receive CRL for zuranolone in major depressive disorder
- FDA Approves ZURZUVAE™ (zuranolone), the First and Only Oral Treatment Approved for Women with Postpartum Depression, and Issues a Complete Response Letter for Major Depressive Disorder
- FDA approves Zurzuvae for postpartum depression
- Biogen trading halted, news pending