MannKind Corporation delivered strong Q3 '25 results, beating EPS and revenue estimates, and shares have responded positively. The FDA accepted the supplemental New Drug Application for the FUROSCIX ReadyFlow Autoinjector, offering rapid furosemide delivery for CHF and CKD patients. I see a substantial TAM, estimating 670,000 to 1.34 million potential U.S. heart failure patients for ReadyFlow, ...
If approved, ReadyFlow Autoinjector would deliver an IV-equivalent diuretic dose (subcutaneous furosemide injection 80 mg/ml) in under 10 seconds Would potentially provide a cost-effective and convenient option to address episodes of fluid buildup at home, benefiting patients, providers and payors PDUFA target action date of July 26, 2026 WESTLAKE VILLAGE, Calif. and BURLINGTON, Mass.
MannKind Corporation ( MNKD ) Discusses Discontinuation of ICoN-1 Phase III Trial for Nebulized Clofazimine in NTM Lung Disease November 10, 2025 9:00 AM EST Company Participants Michael Castagna - CEO & Director Conference Call Participants Olivia Brayer - Cantor Fitzgerald & Co., Research Division Benjamin Burnett - Wells Fargo Securities, LLC, Research Division Faisal Khurshid - Leerink Part...
MannKind has made the decision to discontinue the ICoN-1 Phase 3 clinical trial evaluating nebulized clofazimine inhalation suspension for nontuberculous mycobacterial (NTM) lung disease, following a futility determination based on medical monitoring data This outcome does not impact the development of MNKD-102, MannKind's dry powder inhalation (DPI) formulation of clofazimine, which remains un...
$100,000 in scholarship funds to be distributed to at least 10 students living with diabetes pursuing higher education in life sciences Alfred E. Mann Charities and MannKind are partnering with The Diabetes Link to launch the effort in November for Diabetes Awareness Month DANBURY, Conn.
MannKind Corporation ( MNKD ) Q3 2025 Earnings Call November 5, 2025 9:00 AM EST Company Participants Michael Castagna - CEO & Director Christopher Prentiss - Chief Financial Officer Conference Call Participants Olivia Brayer - Cantor Fitzgerald & Co., Research Division Andreas Argyrides - Oppenheimer & Co. Inc., Research Division Yun Zhong - Wedbush Securities Inc., Research Division Brandon F...
Q3 2025 revenues of $82.1M, +17% v. Q3 2024 YTD 2025 revenues of $237.0M, +14% v.
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