MannKind will present inhaled insulin research at the ADA's Scientific Sessions, highlighting pediatric clinical trial results and education.
Quiver AI Summary
MannKind Corporation will present its inhaled insulin product, Afrezza, at the American Diabetes Association's 85th Scientific Sessions in Chicago from June 20-23, 2025. Dr. Michael J. Haller will lead discussions on the INHALE-1 clinical trial results, focusing on children and adolescents with Type 1 diabetes. Other presentations will include studies on the efficacy and safety of Afrezza in adults with Type 2 diabetes. MannKind will also host a booth at the event for scientific exchanges. The company anticipates releasing full pediatric study data in the second quarter of 2025 and plans to submit a Supplemental Biologics License Application for a pediatric indication later that year.
Potential Positives
- MannKind Corporation will showcase inhaled insulin at the American Diabetes Association's 85th Scientific Sessions, increasing visibility for their innovative product.
- Dr. Michael J. Haller, a noted expert in pediatric endocrinology, will present clinical trial results, potentially enhancing credibility and interest in the company's products.
- The company anticipates releasing topline results from the INHALE-1 study and plans to submit a Supplemental Biologics License Application for a pediatric indication, indicating progress in expanding market opportunities.
- MannKind will engage directly with healthcare professionals at their booth during the conference, facilitating scientific exchange and relationship building in the medical community.
Potential Negatives
- Dependence on upcoming study results and regulatory submissions poses a risk to the company’s future performance and market perception.
- The inclusion of forward-looking statements emphasizes uncertainty, potentially undermining investor confidence.
- Historical performance of similar products could cast doubt on the efficacy and market acceptance of Afrezza, particularly in pediatric populations.
FAQ
What is MannKind Corporation showcasing at the ADA's 85th Scientific Sessions?
MannKind Corporation will showcase inhaled insulin at the ADA's 85th Scientific Sessions in Chicago.
Who will present the results of the INHALE-1 clinical trial?
Dr. Michael J. Haller will present results from the INHALE-1 clinical trial during a symposium on June 22.
When will MannKind release topline results from the pediatric study?
MannKind expects to release topline results from the pediatric study in the second quarter of 2025.
What is Afrezza used for?
Afrezza is an inhaled insulin product used for the treatment of diabetes in children and adults.
Where can attendees learn more about the ADA's Scientific Sessions?
For more information about the ADA's Scientific Sessions, visit https://professional.diabetes.org/scientific-sessions.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., June 09, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) , a company focused on the development and commercialization of inhaled therapeutic products and delivery devices for patients with endocrine and orphan lung diseases, will showcase inhaled insulin at the American Diabetes Association’s (ADA) 85 th Scientific Sessions from June 20-23 in Chicago.
Dr. Michael J. Haller, Professor and Chief of Pediatric Endocrinology at the University of Florida, will present the results from the randomized period of the INHALE-1 clinical trial during a “Future Ready” symposium. Dr. Haller is the Chair for MannKind’s Phase 3 INHALE-1 study of Afrezza (insulin human) Inhalation Powder in children and adolescents (aged 4-17 years of age).
The presentation/posters planned at ADA’s 85 th Scientific Sessions regarding the most recent advances in inhaled insulin treatment include:
Symposium
–
Future Ready – Breakthrough in Pediatric Type 1 Diabetes Care
Sunday, June 22 – 1:30 to 3:00 p.m. (Central) in Room W 181(A-C)
Dr. Michael J. Haller will present: From Discovery to Treatment – Latest Updates on Inhaled Insulin Treatment
Patient Reported Outcomes with Use of Inhaled Technosphere Insulin (T1) (Board 827)
Saturday, June 21, 2025 – 12:30 to 1:30 p.m. (Central)
Presenter: Dr. Peter Calhoun
Efficacy and Safety of Prandial Technosphere Inhaled Insulin (Afrezza) Compared with Placebo in Adult Individuals with T2DM
–
Results from a Phase III Clinical Trial from India (Board No. 833)
Saturday, June 21, 2025 – 12:30 to 1:30 p.m. (Central)
Presenter: Dr. K M Prasanna Kumar
Additionally, MannKind will host booth #1617 in the Exhibit Hall throughout the ADA’s Scientific Sessions. Members of MannKind’s Medical Education Team will be available for scientific exchange in the medical section of the booth.
For more information about ADA’s Scientific Sessions programming, and/or to register to attend the conference, please visit: https://professional.diabetes.org/scientific-sessions .
MannKind expects to issue the topline results from the full study pediatric data set with safety extension in 2Q 2025 and anticipates submitting a Supplemental Biologics License Application in mid-2025 for a potential pediatric indication for Afrezza.
About MannKind
MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases.
We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication.
With a passionate team of Mannitarians collaborating nationwide, we are on a mission to give people control of their health and the freedom to live life.
Please visit mannkindcorp.com to learn more, and follow us on LinkedIn , Facebook , X or Instagram .
Forward-Looking Statements
This press release contains forward-looking statements about a planned release of scientific data and a potential sBLA submission for Afrezza that involves risks and uncertainties. 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 issues that develop in the preparation of data releases and filings may subject us to unanticipated delays as well as other risks detailed in MannKind’s filings with the Securities and Exchange Commission, including under the “Risk Factors” heading of its Annual Report on Form 10-K for the year ended December 31, 2024, 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 and MANNKIND are registered trademarks of MannKind Corporation.