MannKind: Afrezza pediatric sBLA PDUFA itinakda sa Mayo 29, 2026

Tinanggap ng FDA ang supplemental Biologics License Application para sa Afrezza sa mga bata. Nagtalaga ang ahensya ng PDUFA target action date na Mayo 29, 2026, na nagtatatag ng regulatory timeline para sa unang needle-free insulin option sa populasyong ito.

Mahahalagang fact

Na-file: Peb 26, 2026, 01:03 PM
Kaganapan: Naitakda ang petsa ng PDUFA
Direksyon: Neutral
Kumpanya: MNKDMannKind
Asset: insulin human
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · May 29, 2026 · Inaprubahan

Sipi mula sa source

EX-99.1 2 mnkd-ex99_1.htm EX-99.1 EX-99.1 MannKind Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update Conference call today at 9:00 am ET  Q4 2025 revenues of $112M, +46% vs. Q4 2024  Furoscix ® Q4 2025 net sales of $23M, +91% vs. Q4 2024  Afrezza ® Q4 2025 net sales of $23M, +25% vs. Q4 2024  2025 full year revenues of $349M, +22% vs. 2024  Successfully completed the acquisition of scPharmaceuticals Inc. (scPharma)  Program updates:  Afrezza pediatric indication PDUFA date Mayo 29, 2026  Furoscix ReadyFlow ™  Autoinjector PDUFA date Hulyo 26, 2026 DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Peb. 26, 2026 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) a biopharmaceutical company dedicated to transforming chronic disease ca

SEC 8-K