Biogen-Sage's Zuranolone: FDA Says 'Yes' for PPD, 'No' for MDD
- August 05th, 2023
- 359 views
Biogen Inc. (Nasdaq: BIIB) and Sage Therapeutics, Inc. (Nasdaq: SAGE) have received U.S. Food and Drug Administration (FDA) approval for ZURZUVAE (zuranolone) 50 mg, offering a groundbreaking 14-day oral treatment for postpartum depression (PPD) in adults. ZURZUVAE addresses the common symptoms of PPD, including cognitive impairment and feelings of sadness, offering rapid improvements in depressive symptoms to affected women. The treatment is set to launch in Q4 2023, following its classification as a controlled substance by the U.S. Drug Enforcement Administration.
However, not all news was positive as the FDA issued a Complete Response Letter (CRL) for zuranolone's New Drug Application (NDA) in treating major depressive disorder (MDD). The FDA cited insufficient evidence of effectiveness and requested additional studies. Biogen and Sage are collaboratively assessing the feedback and determining their next course of action.
This development falls under a global partnership between the two companies for the joint development and commercialization of zuranolone for various psychiatric disorders, and SAGE-324 for neurological disorders. The agreement splits responsibilities and profits evenly within the U.S., with Biogen taking the lead outside the country, except for Japan, Taiwan, and South Korea. Moreover, outside the U.S., Biogen will compensate Sage through tiered royalties ranging from the high teens to low twenties.
NASDAQ temporarily halted trading for $BIIB and $SAGE prior to the official announcement.
THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY OR DIGITAL ASSET. Please consult with a professional investment advisor before purchasing or selling any securities viewed on or mentioned herein. (Read Full Disclaimer)
Tags
Post Your Comments
Want To Find Some News?
Recent Posts
-
Penguin Solutions, McCormick, and Saratoga Investment Earnings on Deck
October 05th, 2025Key Metrics: Applied Digital, Neogen, and Apogee Enterprises Earnings Due
October 05th, 2025Earnings Loom for PepsiCo, Delta Air Lines, and Levi Strauss: What to Expect
October 04th, 2025Crown Equity Holdings, Inc. Upgrades Outlook Following President Trump's Support of CBD
October 01st, 2025Earnings Spotlight: NIKE, Paychex, and Lamb Weston on the Horizon
September 28th, 2025
Member Login