Data at ADA 2026 Highlights Key Findings from Clinical and Real‑World Studies of MannKind’s Afrezza® (Inhaled Insulin) Across Pediatric Care, Pregnancy, and Use with Automated Insulin Delivery (AID) Systems
Rhea-AI Summary
MannKind (Nasdaq: MNKD) reported new Afrezza and FUROSCIX data to be presented at the ADA 2026 Scientific Sessions. Findings cover pediatric use after recent FDA approval, gestational diabetes, use with automated insulin delivery (AID) systems, pharmacodynamic comparisons with lispro, real‑world safety, access, and heart‑failure outcomes.
Pediatric analyses from INHALE-1 showed non‑inferior HbA1c versus rapid‑acting analogs (RAA) and higher treatment satisfaction in youth achieving HbA1c <8%. Additional studies suggest comparable efficacy in gestational diabetes, earlier pharmacodynamic effect versus lispro, no increased lung cancer incidence, and lower FUROSCIX-related hospitalization rates versus standard care.
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News Market Reaction – MNKD
On the day this news was published, MNKD gained 0.88%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 03 | IPF trial milestones | Positive | -2.0% | Reported Phase 1b randomization completion and first Phase 2 enrollment for nintedanib DPI. |
| May 29 | Approval call | Positive | +3.6% | Conference call scheduled to discuss newly granted Afrezza pediatric approval. |
| May 29 | FDA pediatric approval | Positive | +3.6% | Afrezza approved as first inhaled mealtime insulin for children and adolescents 6+. |
| May 27 | Investor conference | Neutral | +2.5% | Announcement of CEO participation in Jefferies Global Healthcare Conference fireside chat. |
| May 27 | ADA data preview | Positive | +0.6% | Preview of multiple ADA 2026 posters on Afrezza and FUROSCIX, plus pediatric PDUFA date. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent fundamentally positive news (notably Afrezza pediatric approval) has more often been met with modest price gains, though the June 3 IPF trial milestone saw a negative reaction, showing occasional divergence.
Over recent weeks, MannKind has progressed multiple catalysts. On May 29, Afrezza received FDA pediatric approval, with the stock rising about 3.57% alongside a related conference call. On May 27, the company previewed ADA 2026 data, including Afrezza and FUROSCIX analyses, with a smaller 0.57% gain and a positive reaction to a Jefferies conference appearance. The June 3 IPF nintedanib DPI trial milestone, however, coincided with a -2.04% move, illustrating that clinically positive developments do not always translate into immediate share appreciation.
Key Terms
hba1c medical
rapid‑acting analogs medical
gestational diabetes medical
automated insulin delivery medical
euglycemic clamp medical
postprandial glucose medical
pharmacodynamic medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Builds on recent FDA approval (May 29, 2026) of Afrezza for use in children and adolescents aged 6 and older living with type 1 and type 2 diabetes
- New data and real-world findings further emphasize pediatric safety, glycemic control and treatment satisfaction
- Exploratory analysis of inhaled insulin used with AID systems provides insight on the impact of total daily dose algorithms
- Data from randomized cross-over trial supports safety and efficacy of inhaled insulin as an alternative to RAA in gestational diabetes
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., June 05, 2026 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions for cardiometabolic and orphan lung diseases, today announced new clinical and real‑world data related to Afrezza® (insulin human) Inhalation Powder and FUROSCIX® (furosemide injection) that will be presented at the American Diabetes Association’s (ADA) 2026 Scientific Sessions, taking place June 5-8, 2026, in New Orleans, Louisiana.
“As we continue to advance care for people living with diabetes, and on the heels of the recent approval of Afrezza in children and adolescents aged 6 and older, the data presented at this year’s ADA meeting further reinforce its established safety and efficacy, while also highlighting benefits that extend beyond glycemic control and into patients’ daily lives,” said Dr. Kevin Kaiserman, Senior Vice President and Therapeutic Area Head-Diabetes for MannKind Corporation. “We are committed to expanding meaningful treatment options that can help people better manage their diabetes in a way that works for them, and the growing body of evidence for Afrezza supports a more individualized and patient-centered approach to care.”
Key presentations:
Participants Achieving HbA1c <
A post hoc analysis from the INHALE-1 study assessed treatment satisfaction among pediatric participants achieving HbA1c <
Efficacy and Safety of Inhaled Technosphere Insulin (TI) vs. Rapid-Acting Analog in Youth with HbA1c ≤
A subgroup analysis from the INHALE-1 study evaluated efficacy and safety of inhaled insulin compared to rapid‑acting insulin analogs (RAA) in children and adolescents with diabetes with baseline HbA1c ≤
Inhaled Technosphere Insulin (TI) Compared with Rapid-Acting Analog Insulin (RAA) in Gestational Diabetes (GDM)
An interim analysis of standardized meal challenges compared safety and efficacy of inhaled insulin and RAA in individuals with GDM. Inhaled insulin demonstrated comparable efficacy, with nominally reduced postprandial glucose excursions and fewer hypoglycemic events compared to RAA. These early findings support further investigation of inhaled insulin as a potential alternative in this patient population.
Exploratory Evaluation of Technosphere Insulin with Automated Insulin Delivery: Impact of Total Daily Dose Algorithms
An exploratory analysis evaluated the use of inhaled insulin in combination with AID systems for prandial and correction dosing. Findings suggest that glycemic outcomes may vary depending on whether AID algorithms are dependent on total daily dose (TDD), with numerically greater A1C reductions observed in systems not reliant on TDD.
Inhaled Insulin Demonstrates Earlier Completion of Total Pharmacodynamic Effect Compared to Lispro
A new analysis of euglycemic clamp data comparing inhaled insulin to insulin lispro showed that inhaled insulin delivers a substantially greater proportion of its pharmacodynamic effect earlier with over
Additional presentations
In addition to the above presentations, MannKind presented several analyses further characterizing inhaled insulin and FUROSCIX across clinical and real-world settings. These included:
- Dosing strategies and postprandial glucose control in adults with type 1 diabetes, suggested that inhaled insulin resulted in improved glucose excursions with higher doses when adjusted for body weight compared to RAA.
- The impact of the Inflation Reduction Act on access to Afrezza, with increased Medicare Part D utilization, was observed following implementation of the insulin cost cap.
- A real-world evidence study evaluated incident lung cancer risk among adults with type 2 diabetes, which demonstrated no increased incidence among inhaled insulin users compared with other insulin treatment cohorts.
- Research findings evaluated FUROSCIX in populations with comorbid conditions, specifically patients with diabetes who experience fluid overload due to heart failure, which found that treatment with FUROSCIX demonstrated lower rates of hospitalization as well as longer time to hospitalizations compared to the standard of care.
Together, these data underscore MannKind’s ongoing commitment to advancing the clinical understanding of inhaled insulin and strategies for supporting individualized diabetes management across pediatric and adult patient populations.
“These new data reflect the continued momentum of our innovation in diabetes care and the strength of our commitment to expanding treatment options for people aged 6 and older living with this condition,” said Michael Castagna, Chief Executive Officer of MannKind Corporation. “As we look ahead, we remain focused on advancing our pipeline, broadening access, and delivering therapies that better align with the real-world needs of patients.”
About Afrezza
Afrezza® (pronounced uh-frezz-uh) Inhalation Powder is the only ultra rapid-acting inhaled insulin approved by the U.S. Food and Drug Administration to improve glycemic control in children, adolescent, and adult patients with diabetes mellitus. Administered at the beginning of meals using a small, portable inhaler, Afrezza delivers insulin via MannKind’s proprietary Technosphere® technology, enabling ultra-rapid absorption through the lungs. Afrezza has a fast onset of action and a short duration, more closely mirroring the body’s natural insulin response to meals. Afrezza was first approved by the FDA in June 2014 to improve glycemic control in adult patients (age 18+) with diabetes mellitus, followed by an additional FDA approval for use in pediatric patients (age 6 and older) in May 2026.
Important Safety Information
What is the most important information I should know about AFREZZA?
AFREZZA can cause serious side effects, including:
- Sudden lung problems (bronchospasms). In a study, some AFREZZA-treated patients with asthma, whose asthma medication was temporarily withheld, experienced sudden lung problems. Do not use AFREZZA if you have long-term (chronic) lung problems such as asthma or chronic obstructive pulmonary disease (COPD). Before starting AFREZZA, your healthcare provider will give you a breathing test to check how your lungs are working.
What is AFREZZA?
- AFREZZA is a man-made insulin that is breathed-in through your lungs (inhaled) and is used to control high blood sugar in adults and children 6 years of age and older, with diabetes mellitus.
- AFREZZA is not for use to treat diabetic ketoacidosis. AFREZZA must be used with basal insulin in people who have type 1 diabetes mellitus.
- It is not known if AFREZZA is safe and effective for use in people who smoke. AFREZZA is not for use in people who smoke or have recently stopped smoking (less than 6 months).
- It is not known if AFREZZA is safe and effective in children under 6 years of age.
Who should not use AFREZZA?
Do not use AFREZZA if you:
- Are having an episode of low blood sugar (hypoglycemia).
- Have chronic lung problems such as asthma or COPD.
- Are allergic to regular human insulin or any of the ingredients in AFREZZA.
What should I tell my healthcare provider before using AFREZZA?
Before using AFREZZA, tell your healthcare provider about all your medical conditions, including if you:
- Have lung problems such as asthma or COPD
- Have or have had lung cancer
- Are using any inhaled medications
- Smoke or have recently stopped smoking
- Have kidney or liver problems
- Are pregnant, planning to become pregnant, or are breastfeeding. AFREZZA may harm your unborn or breastfeeding baby.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins or herbal supplements.
Before you start using AFREZZA, talk to your healthcare provider about low blood sugar and how to manage it.
What should I avoid while using AFREZZA?
While using AFREZZA do not:
- Drive or operate heavy machinery, until you know how AFREZZA affects you
- Drink alcohol or use over-the-counter medicines that contain alcohol
- Smoke
What are the possible side effects of AFREZZA?
AFREZZA may cause serious side effects that can lead to death, including:
See “What is the most important information I should know about AFREZZA?”
Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include:
- Dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood change, hunger.
Decreased lung function. Your healthcare provider should check how your lungs are working before you start using AFREZZA, 6 months after you start using it, and yearly after that.
Lung cancer. In studies of AFREZZA in people with diabetes, lung cancer occurred in a few more people who were taking AFREZZA than in people who were taking other diabetes medications. There were too few cases to know if lung cancer was related to AFREZZA. If you have lung cancer, you and your healthcare provider should decide if you should use AFREZZA.
Diabetic ketoacidosis. Talk to your healthcare provider if you have an illness. Your AFREZZA dose or how often you check your blood sugar may need to be changed.
Severe allergic reaction (whole body reaction). Get medical help right away if you have any of these signs or symptoms of a severe allergic reaction:
- A rash over your whole body, trouble breathing, a fast heartbeat, or sweating.
Low potassium in your blood (hypokalemia).
Heart failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with AFREZZA may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with AFREZZA. Your healthcare provider should monitor you closely while you are taking TZDs with AFREZZA. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:
- Shortness of breath, swelling of your ankles or feet, sudden weight gain.
Treatment with TZDs and AFREZZA may need to be changed or stopped by your healthcare provider if you have new or worse heart failure.
Get emergency medical help if you have:
- Trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.
The most common side effects of AFREZZA include:
- Low blood sugar (hypoglycemia), cough, sore throat.
These are not all the possible side effects of AFREZZA. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).
Please See Full Prescribing Information, including BOXED WARNING, Medication Guide and Instructions for Use at Afrezza.com/safety.
About FUROSCIX®
FUROSCIX® (furosemide injection), 80 mg/10 mL for subcutaneous use is indicated for the treatment of edema (i.e., congestion, fluid overload, or hypervolemia) in pediatric patients who weigh at least 43 kg and adult patients with chronic heart failure or chronic kidney disease, including the nephrotic syndrome.
IMPORTANT SAFETY INFORMATION
FUROSCIX is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide, any component of the FUROSCIX formulation, or medical adhesives.
Furosemide may cause fluid, electrolyte, and metabolic abnormalities, particularly in patients receiving higher doses, patients with inadequate oral electrolyte intake, and in elderly patients. Serum electrolytes, CO2, BUN, creatinine, glucose, and uric acid should be monitored frequently during furosemide therapy.
Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients.
Furosemide can cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue furosemide.
Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported with furosemide. Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs.
In patients with severe symptoms of urinary retention (because of bladder emptying disorders, prostatic hyperplasia, urethral narrowing), the administration of furosemide can cause acute urinary retention related to increased production and retention of urine. These patients require careful monitoring, especially during the initial stages of treatment.
Contact with water or other fluids and certain patient movements during treatment may cause the On-body Infusor to prematurely terminate infusion. Ensure patients can detect and respond to alarms.
The most common adverse reactions with FUROSCIX administration in clinical trials were site and skin reactions including erythema, bruising, edema, and injection site pain.
Please see the full Prescribing Information (https://www.furoscix.com/wp-content/uploads/prescribing-information.pdf) and Instructions for Use (https://www.furoscix.com/wp-content/uploads/instructions-for-use.pdf).
About MannKind
MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease.
With deep expertise in drug-device combinations, MannKind aims to deliver therapies designed to fit seamlessly into daily life.
Learn more at mannkindcorp.com.
Forward-Looking Statements
Statements in this press release that are not statements of historical fact are forward-looking statements that involve risks and uncertainties. These statements include, without limitation, statements regarding the anticipated presentation of new clinical data, expanding treatment options, advancing MannKind’s pipeline, and broadening access. Words such as “believes”, “anticipates”, “plans”, “expects”, “intends”, “will”, “goal”, “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risk that our products and product candidates may not be able to compete effectively or may be rendered obsolete, and other risks detailed in MannKind’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2025 and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.
AFREZZA, FUROSCIX, MANNKIND and TECHNOSPHERE are registered trademarks of MannKind Corporation.
MannKind Contacts:
Media Relations:
Christie Iacangelo
(818) 292-3500
media@mnkd.com
Investor Relations:
Kate Miranda
(617) 921-5461
ir@mnkd.com
