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2 clusters · 7 sources · 5 days · First seen 14 days ago · Last updated 9 days ago

MannKind Furoscix ReadyFlow approval

Entities: US Food and Drug Administration · Furoscix ReadyFlow · heart failure · MannKind Corp. · Chronic Kidney Disease

Overview

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.

Clinical data from a trial of 21 healthy volunteers showed urine output, sodium and potassium excretion comparable to standard IV 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 United States by the end of August 2026 and plans pharmacy distribution shortly thereafter.

The company also announced the acquisition of scPharmaceuticals for up to $360 million, expanding its pipeline beyond the Furoscix platform.

Claims

What the coverage asserts, and how well corroborated each claim is across sources.

[● 4 SOURCES] The Furoscix ReadyFlow autoinjector delivers furosemide subcutaneously in about ten seconds. (MannKind product description and FDA briefing)
[● 3 SOURCES] The US FDA approved the Furoscix ReadyFlow autoinjector for adult patients with heart failure or chronic kidney disease on July 24, 2026. (FDA approval announcement)
[● 3 SOURCES] The autoinjector achieved equivalent urine output, sodium excretion, and potassium excretion at 6, 8 and 12 hours compared with intravenous furosemide. (Clinical Therapeutics study data)
[● 2 SOURCES] The earlier Furoscix On‑Body Infuser was FDA‑approved in 2022 and delivered furosemide over five hours. (Company product history)
[● 2 SOURCES] MannKind expects the ReadyFlow device to be commercially available in the United States by the end of August. (Company rollout plan)
[○ 1 SOURCE] A trial with 21 healthy volunteers showed the ReadyFlow injection had 107.3% bioavailability (90% CI, 103.9‑110.8). (Phase‑1 pharmacokinetic study)
[○ 1 SOURCE] Adverse events were mainly localized injection‑site reactions; systemic events matched the known safety profile of oral and IV furosemide. (Study safety results)
[○ 1 SOURCE] MannKind agreed to acquire scPharmaceuticals for up to $360 million, paying $5.35 per share plus a $1 contingent value right. (Company acquisition announcement)

Timeline

9 days ago

[HEALTH] 4 sources
MannKind's Furoscix ReadyFlow autoinjector receives US FDA approval
MannKind's Furoscix ReadyFlow autoinjector, delivering furosemide in 10 seconds, has been FDA‑approved for home use in heart‑failure and CKD patients, with comparable efficacy to IV dosing and expected US roll‑
14 days ago

[BUSINESS] 4 sources
MannKind secures $50M financing and FDA approval for Furoscix ReadyFlow auto‑injector
MannKind raised $50 M and received FDA approval for its Furoscix ReadyFlow auto‑injector, a fast subcutaneous furosemide treatment for edema in heart‑failure and kidney‑disease patients, with US rollout slated

Sources

consultantlive.com · drugdeliverybusiness.com · mix929.com · newsable.asianetnews.com · seekingalpha.com · thesheffieldpress.com · wixx.com

This summary has been updated 1 time: see revision history