MannKind's ReadyFlow Autoinjector: A Game Changer For Heart Failure Patients

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, with significant revenue implications.

Seeking Alpha • Dec 3, 2025

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 Failure or Chronic Kidney Disease

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.

GlobeNewsWire • Dec 1, 2025

MannKind to Present at the Jefferies Global Healthcare Conference

DANBURY, Conn. and WESTLAKE VILLAGE, Calif.

GlobeNewsWire • Nov 11, 2025

MannKind Corporation (MNKD) Discusses Discontinuation of ICoN-1 Phase III Trial for Nebulized Clofazimine in NTM Lung Disease Transcript

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 Partners LLC, Research Division Brandon Folkes - H.C. Wainwright & Co, LLC, Research Division Presentation Operator Good morning, and welcome to MannKind Corporation's investor call to discuss a clinical trial update.

Seeking Alpha • Nov 10, 2025

MannKind Provides Update on Phase 3 ICoN-1 Trial of Nebulized Clofazimine for NTM Lung Disease

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 under consideration for future clinical advancement MannKind extends its sincere gratitude to the study participants, investigators, advisors, and clinical site teams for their invaluable contributions to the ICoN-1 study MannKind will host a conference call today at 9:00 AM EST to discuss this update in more detail DANBURY, Conn. and WESTLAKE VILLAGE, Calif.

GlobeNewsWire • Nov 10, 2025

MannKind Commemorates Alfred E. Mann's 100th Birthday with New Scholarship Program Supporting Young Adults Living with Diabetes

$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.

GlobeNewsWire • Nov 6, 2025

MannKind Corporation (MNKD) Q3 2025 Earnings Call Transcript

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 Folkes - H.C. Wainwright & Co, LLC, Research Division Anthony Petrone - Mizuho Securities USA LLC, Research Division Presentation Operator " Michael Castagna CEO & Director " Christopher Prentiss Chief Financial Officer " Olivia Brayer Cantor Fitzgerald & Co., Research Division " Cantor Fitzgerald & Co., Research Division Unknown Analyst " Andreas Argyrides Oppenheimer & Co. Inc., Research Division " Oppenheimer & Co. Inc., Research Division Yun Zhong Wedbush Securities Inc., Research Division " Wedbush Securities Inc., Research Division Brandon Folkes H.C.

Seeking Alpha • Nov 5, 2025

MannKind Corporation Reports Third Quarter 2025 Financial Results and Provides Business Update

Q3 2025 revenues of $82.1M, +17% v. Q3 2024 YTD 2025 revenues of $237.0M, +14% v.

GlobeNewsWire • Nov 5, 2025

MannKind (MNKD) Reports Q3 Earnings: What Key Metrics Have to Say

Although the revenue and EPS for MannKind (MNKD) give a sense of how its business performed in the quarter ended September 2025, it might be worth considering how some key metrics compare with Wall Street estimates and the year-ago numbers.

Zacks Investment Research • Nov 5, 2025

MannKind (MNKD) Tops Q3 Earnings and Revenue Estimates

MannKind (MNKD) came out with quarterly earnings of $0.03 per share, beating the Zacks Consensus Estimate of $0.01 per share. This compares to earnings of $0.04 per share a year ago.

Zacks Investment Research • Nov 5, 2025