Record mula sa primary source
MateryalNaitakda ang petsa ng PDUFA
Kura Oncology: ziftomenib PDUFA itinakda sa Nob 30, 2025 (R/R NPM1-m AML)
Kinumpirma ng 8-K na itinakda ng FDA ang target action date na Nobyembre 30, 2025 para sa ziftomenib monotherapy sa relapsed/refractory NPM1-m AML. Ito ang susunod na regulatory milestone para sa asset bago ang posibleng pag-apruba.
Mahahalagang fact
- Na-file
- Nob 4, 2025, 11:35 AM
- Kaganapan
- Naitakda ang petsa ng PDUFA
- Direksyon
- Neutral
- Kumpanya
KURAKura Oncology- Asset
- ziftomenib
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- Kalendaryo
- Desisyon ng FDA (PDUFA) · Nob 30, 2025 · Walang naitalang resulta
Sipi mula sa source
EX-99.1 2 kura-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Kura Oncology Reports Third Quarter 2025 Financial Results – KOMET 017 Phase 3 trials to evaluate ziftomenib in combination with intensive and non-intensive chemotherapy in frontline AML are accelerating; ziftomenib being investigated in settings representing more than 50% of AML patients – – Two oral presentations at 2025 ASH Annual Meeting on ziftomenib in combination with venetoclax / azacitidine chemotherapy in frontline and R/R NPM1 -m AML – – Clinical data at ESMO 2025 Congress highlight promise of second strategic program – FTIs darlifarnib and tipifarnib show promising safety profile and clinical activity with targeted therapies in solid tumors – – $609.7 million in pro forma cash, together with anticipated collaboration
Higit pa tungkol sa asset na ito
Kapansin-pansin
Ago 12, 2026
08:10 PM
KURAKura OncologyKura Oncology, iniulat ang pinansyal na resulta sa 2Q 2026; $9.1M na kita mula sa KOMZIFTI