MannKind to Highlight Data from Recent Pediatric and Adult Studies of Inhaled Insulin (Afrezza®) at American Diabetes Association's 85th Scientific Sessions in Chicago, June 20-23
MWN-AI** Summary
MannKind Corporation (Nasdaq: MNKD) is poised to showcase its inhaled insulin product, Afrezza, during the American Diabetes Association’s (ADA) 85th Scientific Sessions in Chicago, set for June 20-23, 2025. The company emphasizes its commitment to developing innovative inhaled therapies for endocrine and orphan lung diseases. A highlight of the event will be a presentation by Dr. Michael J. Haller, Professor and Chief of Pediatric Endocrinology at the University of Florida. He will discuss the randomized results from MannKind's Phase 3 INHALE-1 clinical trial focusing on pediatric patients aged 4-17. His presentation, titled “From Discovery to Treatment – Latest Updates on Inhaled Insulin Treatment,” is scheduled for June 22.
The conference will also feature Dr. Peter Calhoun discussing patient-reported outcomes related to inhaled Technosphere Insulin, and Dr. K M Prasanna Kumar presenting data on the efficacy and safety of Afrezza compared with placebo in adults with Type 2 diabetes mellitus, emphasizing the product's clinical significance. MannKind aims to release topline results from its full pediatric data set in the second quarter of 2025, with a Supplemental Biologics License Application submission planned for mid-2025, seeking pediatric approval for Afrezza.
Throughout the conference, MannKind will maintain a presence at booth #1617, fostering scientific dialogue through its Medical Education Team. The company aims to empower patients struggling with diabetes by improving treatment options and outcomes. With a strategic focus on inhalation technologies, MannKind is dedicated to transforming patient care through its specialized formulations and delivery systems. For further inquiries regarding the conference or Afrezza, MannKind encourages interested parties to visit their website or reach out via their provided contact channels.
MWN-AI** Analysis
MannKind Corporation (NASDAQ: MNKD) is at a pivotal moment, particularly as it prepares to showcase its inhaled insulin product, Afrezza, at the American Diabetes Association's 85th Scientific Sessions in Chicago from June 20-23, 2025. This high-profile event will feature key presentations, including findings from the INHALE-1 clinical trial, which are expected to generate significant interest among healthcare professionals and investors alike.
The focus on pediatric applications of Afrezza is particularly noteworthy. With Dr. Michael J. Haller leading discussions on the clinical trial results for children aged 4-17, this could represent a breakthrough for a demographic that has historically lacked effective inhalation therapies. Positive outcomes here could not only enhance the product’s appeal but also pave the way for a Supplemental Biologics License Application later this year, potentially expanding Afrezza’s market.
In adult populations, results presented by Dr. K. M. Prasanna Kumar from India on Afrezza's efficacy and safety compared to placebo in type 2 diabetes patients will provide critical insights into its broader applicability. If favorable, this information could bolster confidence among investors and clinicians, reinforcing MannKind's position in the competitive diabetes management market.
Given MannKind's strategic emphasis on inhaled therapies and recent advancements, market conditions appear promising. Investors should monitor the outcomes presented at the ADA conference closely, as these could significantly affect MNKD's stock performance and investor sentiment. The anticipated topline results coming in 2Q 2025 may serve as a catalyst for further interest.
In conclusion, MannKind operates at a dynamic confluence of innovation and patient need, making it a stock to watch. Success in upcoming trials may not only validate its product line but also enhance its market presence, making it an attractive proposition for forward-looking investors.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news 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.
MannKind Contacts:Media RelationsChristie Iacangelo, (818) 292-3500Email: media@mnkd.comInvestor RelationsAna Kapor, (818) 661-5000Email: ir@mnkd.com
FAQ**
How does MannKind Corporation MNKD's development of inhaled insulin impact the treatment landscape for pediatric diabetes, particularly in relation to Dr. Haller's upcoming presentation at the ADA's Scientific Sessions?
What are the expected implications for MannKind Corporation MNKD regarding the anticipated Supplemental Biologics License Application for Afrezza based on the results from the ongoing INHALE-1 clinical trial?
How does the efficacy and safety data of Afrezza presented at the ADA's Scientific Sessions influence investor sentiment toward MannKind Corporation MNKD in the competitive diabetes treatment market?
What measures is MannKind Corporation MNKD taking to mitigate risks outlined in their forward-looking statements, particularly in relation to the preparation of data releases as they approach the 2Q 2025 topline results announcement?
**MWN-AI FAQ is based on asking OpenAI questions about MannKind Corporation (NASDAQ: MNKD).
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