Risk Factors Update Summary
- Dalzanemdor (SAGE-718) is being evaluated in Phase 2b development for cognition-related disorders.
- Collaboration with Biogen to commercialize ZURZUVAE for postpartum depression treatment, approved by FDA in August 2023.
- Novartis AG acquired Cadent Therapeutics, developing products for Huntington’s disease.
- Uncertainty in achieving revenue goals due to potential market acceptance challenges for ZURZUVAE.
- Collaboration with Biogen for ZURZUVAE may not lead to successful commercialization in the U.S.
- FDA issued a CRL for zuranolone NDA for MDD, requiring additional clinical trials for effectiveness.
- Milestone payment of $75.0 million received for the first commercial sale of ZURZUVAE for PPD.
- Operating expenses expected to decrease in 2024 due to strategic reorganization in August 2023.
- Cash, cash equivalents, and marketable securities were $1.753 billion as of December 31, 2023.
- Potential need for additional capital to fund future development efforts and commercialization.
Full Text Changes in Most Recent 10-K
Intended use: review the highlighted statements. These are additions to the risk factors disclosure in the most recent 10-K filing compared to the previous 10-K filing. Deleted and moved text is less important and is shown for context.
To view the full company filings, click on the following link to be taken to the SEC EDGAR database landing page for the company: https://www.sec.gov/edgar/browse/?CIK=1597553&owner=exclude
This content requires a 'Free' membership to view. Please create one here.
This content requires a 'Free' membership to view. Please create one here.