Latest news with #INHALE-1
Yahoo
2 days ago
- Business
- Yahoo
MannKind (MNKD) Secures $500M Financing to Advance Inhaled Therapies Pipeline
We recently published . MannKind Corporation (NASDAQ:MNKD) is one of the best healthcare stocks. MannKind Corporation (NASDAQ:MNKD)'s most recent milestone is its push to expand the use of its rapid-acting inhaled insulin, Afrezza, to pediatric patients. In August 2025, the company submitted a supplemental Biologics License Application to the FDA for use in children ages 4–17, supported by positive Phase 3 INHALE-1 trial results presented at major diabetes conferences. A regulatory decision is expected in Q4 2025. Clinical data from both pediatric (INHALE-1) and adult (INHALE-3) studies have reinforced Afrezza's efficacy and safety across age groups. These advances have also helped the business gain attention among investors looking at the best healthcare stocks. Beyond Afrezza, MannKind Corporation (NASDAQ:MNKD) is advancing its pipeline in respiratory and rare diseases. MNKD-101, an inhaled clofazimine for nontuberculous mycobacterial lung disease, is progressing ahead of schedule in its global Phase 3 ICoN-1 trial. MNKD-201, a therapy for idiopathic pulmonary fibrosis, is set to enter Phase 2 testing by the end of 2025. Copyright: nicoletaionescu / 123RF Stock Photo To support these initiatives, the business secured up to $500 million in non-dilutive financing from Blackstone in August 2025. This funding will accelerate the potential launch of pediatric Afrezza, expand its commercial capabilities, and advance its clinical programs. Together, these developments position MannKind Corporation (NASDAQ:MNKD) for growth in both diabetes care and specialty lung disease markets. While we acknowledge the potential of MNKD as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None.
Yahoo
10-06-2025
- Health
- Yahoo
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
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) 85th 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 85th 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: 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 MannKindMannKind 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 to learn more, and follow us on LinkedIn, Facebook, X or Instagram. Forward-Looking StatementsThis 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. CONTACT: MannKind Contacts: Media Relations Christie Iacangelo, (818) 292-3500 Email: media@ Investor Relations Ana Kapor, (818) 661-5000 Email: ir@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
09-06-2025
- Health
- Yahoo
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
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) 85th 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 85th 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: 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 MannKindMannKind 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 to learn more, and follow us on LinkedIn, Facebook, X or Instagram. Forward-Looking StatementsThis 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. CONTACT: MannKind Contacts: Media Relations Christie Iacangelo, (818) 292-3500 Email: media@ Investor Relations Ana Kapor, (818) 661-5000 Email: ir@ in to access your portfolio
Associated Press
10-03-2025
- Health
- Associated Press
MannKind Showcases Efficacy, Safety, and Mealtime Control Data from Recent Pediatric and Adult Studies of Afrezza® at the ATTD Conference, March 19-22
Five presentations affirm positive outcomes utilizing inhaled insulin An sNDA filing for Afrezza in pediatric population anticipated in 2025 DANBURY, Conn. and WESTLAKE VILLAGE, Calif., March 10, 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 data from recent studies of inhaled insulin across five presentations at the 18th International Conference on Advanced Technologies and Treatments for Diabetes to be held March 19-22 in Amsterdam. 'Data from both the INHALE-1 pediatric and INHALE-3 adult studies continue to drive groundbreaking conversations around inhaled insulin,' said Dr. Kevin Kaiserman, Senior Vice President, Therapeutic Area Head, Endocrine Diseases for MannKind Corporation. 'Afrezza continues to be an important treatment option for adults living with diabetes, including those utilizing MDI and AID, and we look forward to the study investigators' presentations at the ATTD meeting.' The following oral presentations are on the scientific program at ATTD 2025 to be held virtually and at the RAI Amsterdam Convention Center: What's New in Pulmonary Inhaled Insulin? Thursday, March 20, 2025 – 4:40 PM (CET) in Hall I Presenter: Dr. Irl B. Hirsch Inhaled Insulin in Pediatrics (INHALE-1 Peds Study) Thursday, March 20, 2025 – 4:40 PM (CET) in Hall I Presenter: Dr. Michael J. Haller Sustained Benefit from Use of Inhaled Insulin in the INHALE-3 Extension Study Saturday, March 22, 2025 – 11:05 AM (CET) at Station 4 Presenter: Dr. Grazia Aleppo Post-Prandial Glucose Excursion with Inhaled Insulin in Youth Compared with Adults with Type 1 Diabetes (INHALE-1 Peds Study) Saturday, March 22, 2025 – 11:30 AM (CET) in Hall D2 Presenter: Dr. Michael J. Haller Comparison of a Regimen of Inhaled Technosphere Insulin Plus Insulin Degludec Versus Usual Care in Adults with Type 1 Diabetes Saturday, March 22, 2025 – 11:30 AM (CET) in Hall D2 Presenter: Dr. Anastasios Manessis In addition to the planned presentations, MannKind will host booth #40 in the exhibit hall (Hall I) throughout ATTD. Members of MannKind's Clinical Education Team will be available for scientific exchange in the medical section of the booth. For more information about ATTD programming, and/or to register to attend the conference (virtual or in person), please visit: About the INHALE-1 Pediatric Study INHALE-1 is a Phase 3, randomized controlled trial in children and teenagers aged 4-17 with type 1 or type 2 diabetes to evaluate the efficacy and safety of inhaled insulin in combination with basal insulin versus multiple daily injections of rapid acting insulin in combination with basal insulin. The 26-week, open-label clinical trial randomized 230 pediatric subjects to one of two groups: Afrezza or multiple daily injections (MDI) of rapid acting insulin analog (RAA) in combination with basal insulin. The primary endpoint was a non-inferior change in HbA1c levels after 26 weeks. A 26-week extension phase in which all remaining MDI patients switched to Afrezza is still ongoing. Six-month results were announced by MannKind in December 2024, and 12-month findings are expected mid-year 2025. About the INHALE-3 Study (Adults) The INHALE-3 study was a 17-week, randomized controlled trial with a 13-week extension conducted across 19 U.S. sites. The study, which enrolled 141 patients (123 randomized), assigned participants over 18 years of age with T1D who are using MDI, an automated insulin delivery system, or a pump without automation to either continue their standard of care or initiate an insulin regimen of a daily basal injection plus Afrezza for boluses (mealtime and corrections). Subjects utilizing Afrezza (inhaled insulin) received a higher initial conversion dose than in the current U.S. product label. Both arms utilized continuous glucose monitoring to assess glucose control. The randomized control trial (RCT) included an inhaled insulin group that began with 62 subjects at randomization and 57 at 17 weeks; the usual care group consisted of 61subjects at randomization and 58 at 17 weeks. The 17-week results shared that the study met its primary efficacy endpoint of a non-inferior change in HbA1c between baseline and week 17 compared to the usual care group. At 17 weeks, those who utilized Afrezza (plus basal insulin) continued with it through the extension phase, and those who were on usual care switched over to Afrezza to week 30. The extension phase started with 45 subjects from the inhaled insulin group and 43 completed the extension; the usual care-to-Afrezza group started with 49 in the extension, with 42 completing. There was no control group in the extension phase. A1c levels were obtained at baseline, 17 and 30-weeks. The 30-week results from the study expanded upon the positive 17-week data and showed that more people living with T1D were able to reach target A1c levels when they remain on Afrezza (plus basal insulin) or switch to Afrezza from usual care. About Afrezza Afrezza (insulin human) Inhalation Powder is a rapid-acting inhaled human insulin indicated to improve glycemic control in adults with diabetes mellitus. Limitations of Use: Not recommended for the treatment of diabetic ketoacidosis or in patients that smoke or have recently stopped smoking. Important Safety Information WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE Acute bronchospasm has been observed in Afrezza-treated patients with asthma and COPD Afrezza is contraindicated in patients with chronic lung disease such as asthma or COPD Before initiating Afrezza, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients. Most common adverse reactions are hypoglycemia, cough, and throat pain or irritation. Please see additional Important Safety Information, Full Prescribing Information, including BOXED WARNING, available on 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 to learn more, and follow us on LinkedIn, Facebook, X or Instagram. Forward-Looking Statements This press release contains forward-looking statements about planned presentations at a scientific conference and a potential sNDA 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 review by the FDA may subject us to unanticipated delays or prevent us from obtaining the expanded indication 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.
