MannKind: FDA nagtakda ng Mayo 29, 2026 PDUFA para sa Afrezza pediatric sBLA

Tinanggap ng FDA ang supplemental BLA para sa Afrezza sa populasyon ng bata (4-17 taong gulang) at nagtalaga ng PDUFA target action date na Mayo 29, 2026. Ito ay nagtatatag ng pormal na timeline ng regulatory review para sa pagpapalawak ng label ng Afrezza sa mas batang mga pasyente.

Mahahalagang fact

Na-file: Nob 5, 2025, 01:03 PM
Kaganapan: Naitakda ang petsa ng PDUFA
Direksyon: Positibo
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 CORPORATION REPORTS THIRD QUARTER 2025 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE Conference call today at 9:00 am ET • Q3 2025 revenues of $82.1M, +17% v. Q3 2024 • YTD 2025 revenues of $237.0M, +14% v. YTD 2024 • Completed acquisition of scPharmaceuticals on October 7, accelerating MannKind’s revenue growth with FUROSCIX ® • Program updates: o sBLA for Afrezza ® in pediatric population accepted for FDA review; PDUFA date of May 29, 2026 o FUROSCIX ReadyFlow™ Autoinjector sNDA submitted to the FDA o MNKD-101 NTM global Phase 3 trial (ICoN-1) achieved interim enrollment target ahead of schedule o MNKD-201 IPF Phase 2 trial (INFLO) initiated and expect to enroll first patient in Q1 2026 DANBURY, Conn. and WESTLAKE VILLAGE, Ca

SEC 8-K