Welcome to our dedicated page for Mannkind news (Ticker: MNKD), a resource for investors and traders seeking the latest updates and insights on Mannkind stock.
MannKind Corporation (Nasdaq: MNKD) generates frequent news across product, clinical, regulatory, and corporate fronts as it advances therapies for cardiometabolic and orphan lung diseases. News coverage for MNKD often centers on its commercial products Afrezza, FUROSCIX, V-Go, and Tyvaso DPI–related collaborations, as well as updates on its inhaled and subcutaneous pipeline.
Investors and healthcare observers following MNKD news can expect announcements on U.S. Food and Drug Administration (FDA) milestones, including supplemental Biologics License Applications and supplemental New Drug Applications. Recent examples include FDA acceptance for review of an sBLA for Afrezza in children and adolescents with type 1 or type 2 diabetes, and acceptance of an sNDA for the FUROSCIX ReadyFlow Autoinjector for edema in adults with chronic heart failure or chronic kidney disease.
MannKind’s news flow also covers clinical trial progress and portfolio decisions in orphan lung diseases. The company has reported on initiation of nintedanib DPI (MNKD-201) studies for idiopathic pulmonary fibrosis, as well as the discontinuation of the Phase 3 ICoN-1 trial of nebulized clofazimine (MNKD-101) for refractory nontuberculous mycobacterial lung disease following a futility analysis. Updates on pre-clinical programs such as bumetanide DPI and MNKD-102 are also featured in its communications.
Corporate and financial news items include quarterly earnings results, revenue breakdowns across royalties, collaborations, and product sales, and strategic transactions. A notable example is MannKind’s acquisition of scPharmaceuticals, which brought FUROSCIX fully into its portfolio and expanded its presence in cardiometabolic care. The company also issues releases about investor conference presentations and community initiatives, such as the Centennial Al Mann Scholarship for students living with diabetes.
This news page aggregates these developments so readers can review regulatory decisions, trial outcomes, business combinations, and financial updates related to MannKind in one place.
MannKind (NASDAQ: MNKD) will present new clinical and real‑world data on Afrezza inhaled insulin at ATTD 2026 in Barcelona, March 11–14, 2026. Presentations include two oral sessions and a poster covering post‑prandial glucose control and pediatric dosing/titration from the INHALE‑1 study.
The company noted pediatric dosing began at an approximately 2:1 conversion from rapid‑acting insulin analogs in INHALE‑1. A supplemental BLA for Afrezza in children ages 4–17 is under FDA review with a PDUFA target action date of May 29, 2026.
MannKind (Nasdaq: MNKD) announced settlement of the remaining $36.3 million aggregate principal amount of 2.50% convertible senior notes, all tendered for conversion prior to the March 1, 2026 maturity.
The company settled on March 4, 2026 using $35.5 million in cash and issuance of 569,023 shares of common stock.
MannKind (Nasdaq: MNKD) will participate in two investor conferences in Miami on March 10–11, 2026. CEO Michael Castagna, PharmD, and CFO Chris Prentiss will do fireside chats and 1x1 investor meetings.
Live audio webcasts and recorded sessions will be available on the company's investor website for about 90 days.
MannKind (Nasdaq: MNKD) reported Q4 2025 revenue of $112M, up 46% year-over-year, and full year 2025 revenue of $349M, up 22% vs. 2024. Furoscix and Afrezza each generated about $23M in Q4 2025.
The company completed the scPharma acquisition, holds $176M in cash and investments, and flagged two FDA PDUFA dates: Afrezza pediatric on May 29, 2026 and Furoscix ReadyFlow on July 26, 2026. Nintedanib DPI Phase 1b topline data expected in 2H 2026.
MannKind (Nasdaq: MNKD) announced CEO Michael Castagna, PharmD, will present business updates at the Oppenheimer 36th Annual Healthcare Life Sciences Conference on Thursday, February 26, 2026 at 11:20 a.m. ET.
A webcast link will be available on the company website and recorded versions will be posted for approximately 90 days.
MannKind (Nasdaq: MNKD) said it will release its fourth quarter and full year 2025 financial results before market open on Thursday, February 26, 2026. A live webcast reviewing results and providing a business update will begin at 9:00 a.m. ET.
The webcast will be accessible via MannKind's investor website link and a replay will be available within 24 hours and remain accessible for about 90 days.
MannKind (NASDAQ: MNKD) announced first patient enrollment in INHALE-1ST, a single-arm U.S. study evaluating initiation of Afrezza inhaled insulin with once-daily basal insulin in youth aged 10 to <18 years newly diagnosed with type 1 diabetes.
About 100 patients across ~10 sites will be followed 13 weeks (plus optional extension to 26 weeks); primary endpoint is ≥70% time-in-range (70–180 mg/dL) by CGM. An Afrezza pediatric sBLA is under FDA review with a PDUFA date of May 29, 2026.
MannKind (Nasdaq: MNKD) announced that the U.S. Food and Drug Administration approved an update to the Afrezza prescribing information on January 26, 2026 to provide starting mealtime dose guidance when switching adult patients from subcutaneous mealtime insulin (multiple daily injections or insulin pump boluses) to inhaled Afrezza.
The label revision includes a conversion table mapping current injected mealtime doses to recommended Afrezza starting doses (e.g., up to 3 units → 4 units; 4–5 → 8 units; 6–7 → 12 units; 8+ → 16 units). The change was supported by modeling and in vivo data from the Dose Optimization study and the INHALE-3 trial showing improved postprandial glucose outcomes with the approved conversion doses.
MannKind (Nasdaq: MNKD) provided business updates and outlined 2026 growth drivers including commercial momentum, recent acquisition activity, and clinical progress.
Key points: a record fourth quarter with net revenue >$100 million, acquisition of scPharmaceuticals, multiple FDA review acceptances with PDUFA dates (Afrezza label update Jan 23, 2026; Afrezza pediatric sBLA May 29, 2026; FUROSCIX ReadyFlow sNDA July 26, 2026), first patient enrolled in INFLO-1 (nintedanib DPI) in Dec 2025, and ongoing collaborations with United Therapeutics including a planned Tyvaso DPI bridging study.
MannKind (Nasdaq: MNKD) announced FDA approval of FUROSCIX On-body Infusor for pediatric patients weighing 43 kg or more and reported issuance of five U.S. patents for the FUROSCIX ReadyFlow Autoinjector, extending IP protection potentially through 2040. The ReadyFlow autoinjector is under FDA review with a PDUFA target action date of July 26, 2026 and, if approved, would deliver an IV-equivalent subcutaneous furosemide dose (80 mg/mL) in under 10 seconds. The pediatric sNDA fulfillment completes post-marketing Pediatric Research Equity Act requirements for FUROSCIX, which previously had adult approvals for CHF (2022) and CKD (2025).