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MannKind Furoscix ReadyFlow approval
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2026-07-29 16:21 UTC → 2026-07-29 23:50 UTC ·
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MannKind Corporation secured a $50 million private placement and received FDA approval for its Furoscix ReadyFlow auto‑injector in late July 2026. The financing, led by Frazier Life Sciences, will fund general corporate purposes and includes a $45 million contingent‑value‑rights payment linked to regulatory clearance. The FDA cleared the sub‑cutaneous device, which delivers an 80 mg/mL dose of furosemide in under 10 seconds, offering an at‑home alternative to IV therapy for adults with heart failure or chronic kidney disease. The company plans a U.S. commercial launch by August 2026, with the product expected to reach pharmacies by the end of that month. Clinical data from a trial of 21 healthy volunteers showed urine output output, sodium and electrolyte potassium excretion comparable to standard IV treatment. A peripheral mention of a Taiwanese blood‑based TB biosensor appeared furosemide at 6, 8 and 12 hours, with bioavailability around 107 % and safety limited to local injection‑site reactions and expected systemic effects. MannKind expects commercial availability in the same release, but the core development remains United States by the approval end of August 2026 and financing plans pharmacy distribution shortly thereafter. The company also announced the acquisition of scPharmaceuticals for up to $360 million, expanding its pipeline beyond the Furoscix ReadyFlow system. platform.
Versions
- 2026-07-29 23:50 UTC MannKind Furoscix ReadyFlow approval
- 2026-07-29 16:21 UTC MannKind Furoscix ReadyFlow approval
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