Sage Gets More Time For Zulresso Launch Preparations With Delay Of US FDA Approval
After an advisory committee recommended approval for the postpartum depression treatment if administered under a REMS program at certified centers, Sage submitted a proposed REMS, causing the agency to extend the PDUFA date three months.
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Datamonitor projects the newly US FDA-approved esketamine product for treatment-resistant depression will reach sales of almost $2bn in the US, Japan and five major European markets.
Anthos premiers with $250m from Blackstone and cardiovascular disease assets and expertise from Novartis, while Maze brings in $191m for drugs that target gene modifiers. In public company financings, Sage raises $575m ahead of Zulresso approval decision.
Highlights from the past year's financings include BeiGene's $800m follow-on offering in the US and $903m Hong Kong IPO, Moderna's $560m Series G round and $604m IPO, and Allogene's $300m Series A and $373m IPO.