As of Oct 28, 2026: Kura Oncology (KURA) announced the FDA's approval of ziftomenib on Jan 12, 2026; its PDUFA date was Nov 30, 2025. Its Quality Score is 0. Scores as of 6:48 AM ET, 15 minutes behind.

KURA FDA decision on Ziftomenib

Kura Oncology · PDUFA date

OutcomeApprovedannounced Jan 12 Quality Score0Below Average

Cash runway–not counted

The FDA's decision

Approved. Kura Oncology announced the FDA's approval of ziftomenib on Jan 12, 2026.

“Continued regulatory interactions with the FDA ahead of the November 30, 2025 PDUFA target action date for ziftomenib as a monotherapy for adult patients with relapsed or refractory NPM1 -m…”

PDUFA date, Nov 30, 2025. As Kura Oncology stated in its 8-K of Nov 4, 2025 (the filing).

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