MannKind Announces U.S. FDA Accepts for Review its Supplemental New Drug Application (sNDA) of FUROSCIX ReadyFlow™ Autoinjector for the Treatment of Edema in Adults with Chronic Heart Fail...
MannKind Corporation (MNKD)
Last mannkind corporation earnings: 2/25 08:00 am
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Source: GlobeNewswire
If approved, ReadyFlow Autoinjector would deliver an IV-equivalent diuretic dose (subcutaneous furosemide injection 80 mg/ml) in under 10 secondsWould potentially provide a cost-effective and convenient option to address episodes of fluid buildup at home, benefiting patients, providers and payorsPDUFA target action date of July 26, 2026 WESTLAKE VILLAGE, Calif. and BURLINGTON, Mass., Dec. 01, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today announced that the U.S. Food and Drug Administration (FDA) has accepted the sNDA seeking approval for FUROSCIX ReadyFlow™ Autoinjector (SCP-111), developed to deliver a subcutaneous furosemide injection in under 10 seconds as an investigational alternative to the FDA-approved FUROSCIX® (furosemide) On-body Infusor for treatment of edema in adult patients with chronic heart failure (CHF) or chronic kidney disease (CKD). The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of July 26, 2026
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News
- Reassessing MannKind (MNKD) Valuation After Recent Share Price Reset [Yahoo! Finance]Yahoo! Finance
- MannKind (NASDAQ:MNKD) was given a new $9.00 price target on by analysts at Truist Financial Corporation.MarketBeat
- MannKind (NASDAQ:MNKD) is now covered by analysts at Truist Financial Corporation. They set a "buy" rating on the stock.MarketBeat
- MannKind (NASDAQ:MNKD) is now covered by analysts at Leerink Partners. They set an "outperform" rating and a $7.00 price target on the stock.MarketBeat
- MannKind to Present at the Jefferies Global Healthcare Conference [Yahoo! Finance]Yahoo! Finance
MNKD
Earnings
- 11/5/25 - Beat
MNKD
Sec Filings
- 12/4/25 - Form 4
- 12/4/25 - Form 4
- 12/2/25 - Form 144
- MNKD's page on the SEC website