FDA Priority Review and Regulatory Progress for Ziftomenib
The FDA has accepted Kura's NDA for ziftomenib in relapsed/refractory NPM1-mutant AML, granting a priority review with a PDUFA date of November 30, 2025.
Management reports ongoing collaborative and constructive interactions with the FDA, emphasizing alignment with the review timeline.
Regulatory milestones include addressing information requests and preparing for pre-approval inspections, with a focus on ensuring a successful review outcome.
Strategic Review Concludes with Focus on Portfolio Optimization and Asset Divestitures
The company completed an extended strategic review in June, reaffirming its position as a leading independent short-stay surgical provider.
Management plans to selectively partner or sell facilities to reduce leverage, accelerate cash flow, and focus on core ASC service lines.
Potential divestitures include surgical hospitals and non-core assets, with a focus on markets that can expedite leverage reduction and cash flow growth.
The company is considering partnerships with health systems, including selling stakes in assets to accelerate strategic goals.
Dafinchi
