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.

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