FUROSCIX ReadyFlow Autoinjector (SCP-111) was approved by the FDA on July 23, 2026 for edema in adult patients with chronic heart failure (CHF) or chronic kidney disease (CKD).
Verified against: FDA action day July 23, 2026 (NDA 209988 S-007) · Announcement July 24, 2026 (sponsor announcement) · Goal date July 26, 2026 (source not recorded on this row).
FUROSCIX ReadyFlow (furosemide) Autoinjector approved as the first and only autoinjector delivering IV-equivalent diuretic therapy for edema in adults with chronic heart failure or chronic kidney disease, two days ahead of its PDUFA goal date (Jul 24 2026).
The PDUFA goal date was July 26, 2026. The FDA approved on July 24, 2026, two days early.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Primary source: MannKind Corporation investor release, July 24, 2026
FDA record of the action: the FDA approved on July 23, 2026, per NDA 209988 S-007 (FDA letter). The sponsor announced it on July 24, 2026. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
Yes. The FDA approved the application for FUROSCIX ReadyFlow Autoinjector (SCP-111) on July 23, 2026, per the FDA's own record. The company announced it on July 24, 2026. The primary source is linked on this page.
FUROSCIX ReadyFlow Autoinjector (SCP-111) is a MannKind Corporation (MNKD) program. The FDA decision came on July 23, 2026; the company's own announcement is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), MNKD moved -33.7%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.