MannKind: Afrezza pediatric PDUFA itinakda sa Mayo 29, 2026

Ang press release ay nagsasaad ng PDUFA target action date na Mayo 29, 2026 para sa Afrezza pediatric indication. Ang pangalawang PDUFA date na Hulyo 26, 2026 ay ibinigay para sa Furoscix ReadyFlow Autoinjector. Ang parehong petsa ay mga hinaharap na milestone at hindi kumakatawan sa isang resulta.

Mahahalagang fact

Na-file: May 6, 2026, 08:03 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 First Quarter 2026 Financial Results and Provides Business Update  Q1 updates:  Q1 2026 total revenues of $90.2M, +15% vs. Q1 2025  Built out launch infrastructure and aligned field-based teams for upcoming launches  Settlement of senior convertible notes of $36.3M  Program updates:  Afrezza ® pediatric indication PDUFA date Mayo 29, 2026  Furoscix ReadyFlow ™  Autoinjector PDUFA date Hulyo 26, 2026  Nintedanib DPI (MNKD-201) for IPF advancing into Phase 2; INFLO-2 trial anticipates enrolling first patient in Q2 2026  Ralinepag DPI (MNKD-1501) announced as collaboration program with United Therapeutics, received additional $5M to support accelerated development  Conference call and webcast today at 4:30 p.m. E

SEC 8-K