Edema in Adults with Chronic Heart Failure (CHF) or Chronic Kidney Disease (CKD)
MNKDMannKind CorporationCatalyst overview
Research summary
This catalyst tracks a Approved update for FUROSCIX ReadyFlow™ Auto-Injector Injection (furosemide) in Edema in Adults with Chronic Heart Failure (CHF) or Chronic Kidney Disease (CKD). The expected timing is based on the latest available company guidance and may change.
Asset acquired from acquisition of scPharmaceuticals (SCPH). 9/19/23- Positive feedback from Type C meeting. 4/24/24- Initiated PK study & enrolled 1st patient. 8/12/24- Achieved primary PK and secondary PD endpoints. 12/1/25- sNDA accepted with PDUFA date July 26, 2026. 02/26/26:- Furoscix ReadyFlow Autoinjector sNDA remains under FDA review; PDUFA target action date July 26, 2026 reiterated. 05/06/26:- Furoscix ReadyFlow autoinjector PDUFA target action date reiterated as July 26, 2026. 07/24/26:- FDA approved Furoscix ReadyFlow for adult HF/CKD edema; U.S. launch expected by end-August 2026. 08/05/26:- ReadyFlow approval and late-August commercial availability were reiterated.
Verification
Confirm timing and program details against the company announcement or filing.