FUROSCIX ReadyFlow Autoinjector (SCP-111)
- Indication
- Edema in adult patients with chronic heart failure (CHF) or chronic kidney disease (CKD)
- Stage
- phase5
- Event
- Regulatory Decision
- Details
Feb. 26, 2026: MannKind Corporation (Nasdaq: MNKD) reported Q4 and full-year 2025 results and provided 2026 catalyst updates, following completion of its acquisition of scPharmaceuticals (scPharma) on Oct. 7, 2025.
Furoscix (furosemide injection): Q4 2025 net sales were $23.2M (91% increase vs. Q4 2024 as reported by scPharma). FDA accepted a supplemental NDA for Furoscix ReadyFlow Autoinjector; PDUFA target action date is July 26, 2026.
Afrezza (insulin human) Inhalation Powder: Q4 2025 net sales were $22.9M (+25% vs. Q4 2024). FDA accepted a supplemental BLA for a pediatric indication; PDUFA target action date is May 29, 2026. The company also notes an FDA-approved updated Afrezza label in Q1 2026 with starting-dose guidance when switching from MDI or insulin pump mealtime therapy, and that Afrezza launched in India by Cipla.
Nintedanib DPI (MNKD-201): Phase 1b INFLO-1 enrollment is underway with topline data expected in 2H 2026; a Phase 2 IPF trial (INFLO-2) was initiated with first patient planned in Q2 2026.
Other programs: MNKD-1501 formulation work under an expanded United Therapeutics collaboration; Bumetanide DPI (MNKD-701) entered preclinical development.
- Source
- View catalyst source ↗