Sage Therapeutics announced the FDA approval of ZURZUVAE for postpartum depression (PPD) and is preparing for its launch in Q4 2023. The company is disappointed by the Complete Response Letter (CRL) from the FDA regarding zuranolone for major depressive disorder (MDD). The company is evaluating resource allocation, including pipeline prioritization and workforce reorganization, to extend its cash runway.
ZURZUVAE was approved by the FDA as the first-and-only oral treatment specifically indicated for adults with PPD and is on-track for planned launch in the fourth quarter of 2023.
Sage is evaluating resource allocation, including pipeline prioritization and a workforce reorganization with a goal of extending our cash runway.
Sage brain health pipeline provides potential for significant long-term value creation.
The company remains well capitalized with $1.0 billion of cash, cash equivalents and marketable securities as of June 30, 2023.
Sage expects that its current cash, cash equivalents and marketable securities, along with anticipated funding from ongoing collaborations and potential revenue, will support its operations into 2025. Sage is evaluating resource allocation, including pipeline prioritization and a workforce reorganization, with a goal of extending its cash runway and anticipates operating expenses will decrease in 2024.
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