FDA Approves Afrezza for Pediatric Diabetes Management
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 20 minutes ago
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Source: Newsfilter
- New Drug Approval: The FDA has approved MannKind's Afrezza inhalation powder for children and adolescents aged 6 and older with diabetes, representing a new treatment option that is expected to improve the quality of life for over 350,000 children in the U.S.
- Clinical Support: This approval is backed by positive results from the INHALE-1 clinical trial, along with safety and efficacy data accumulated over 20 years of Technosphere® inhaled insulin development, showcasing Afrezza's advantages in rapid absorption and ease of use.
- Economic Accessibility: Eligible patients can now access Afrezza for $35 or less per month, with MannKind Cares providing dedicated support to help patients obtain medications and insurance information, thereby reducing the financial burden of diabetes treatment.
- Personalized Treatment: Afrezza's rapid onset allows for dosing at mealtime, catering to the daily lives of children and adolescents, offering a needle-free insulin option that aligns with family needs and advancing the progress of personalized medicine.
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About MNKD
MannKind Corporation is a biopharmaceutical company engaged in transforming chronic disease care through patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, it develops and commercializes treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease. Its commercial assets include Afrezza, FUROSCIX and V-Go along with Tyvaso DPI. Its commercializing Afrezza (insulin human) Inhalation Powder, an ultra-rapid-acting inhaled insulin indicated to improve glycemic control in adults with diabetes, and the V-Go wearable insulin delivery device, which provides continuous subcutaneous infusion of insulin in adults that require insulin. Its orphan lung disease product, Tyvaso DPI (treprostinil) inhalation powder, is used in the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
FDA Approves Afrezza for Pediatric Diabetes Management
- New Drug Approval: The FDA has approved MannKind's Afrezza inhalation powder for children and adolescents aged 6 and older with diabetes, representing a new treatment option that is expected to improve the quality of life for over 350,000 children in the U.S.
- Clinical Support: This approval is backed by positive results from the INHALE-1 clinical trial, along with safety and efficacy data accumulated over 20 years of Technosphere® inhaled insulin development, showcasing Afrezza's advantages in rapid absorption and ease of use.
- Economic Accessibility: Eligible patients can now access Afrezza for $35 or less per month, with MannKind Cares providing dedicated support to help patients obtain medications and insurance information, thereby reducing the financial burden of diabetes treatment.
- Personalized Treatment: Afrezza's rapid onset allows for dosing at mealtime, catering to the daily lives of children and adolescents, offering a needle-free insulin option that aligns with family needs and advancing the progress of personalized medicine.
See More
MannKind Set to Present Afrezza Data Amid FDA Decision
- FDA Decision Focus: MannKind's inhaled insulin Afrezza has a PDUFA target action date of May 29, which, if approved, would allow use in children aged 4 to 17, potentially expanding the market and boosting company performance significantly.
- Clinical Trial Results: The Phase 3 trial results released last October demonstrated that Afrezza, when used alongside multiple daily insulin injections, effectively improves blood sugar control and enhances treatment satisfaction, further supporting the FDA application.
- Market Sentiment Shift: Investor sentiment has shifted from neutral to bullish ahead of the FDA decision, with many users on social media discussing the potential for significant stock price increases post-approval, indicating strong market confidence in MannKind.
- Data Presentation Plans: MannKind is set to present additional Afrezza-related data at the American Diabetes Association Scientific Sessions, including analyses on pediatric treatment satisfaction and A1c tests, further enhancing the company's influence in diabetes treatment.
See More
MannKind Unveils New Afrezza Data Ahead of FDA Review
- Pediatric Clinical Data: MannKind will present new efficacy data for Afrezza in children and adolescents with diabetes at the 2026 American Diabetes Association Scientific Sessions, potentially advancing the FDA review process set for May 29, 2026, which could provide the first needle-free insulin option for pediatric patients.
- Patient Satisfaction Analysis: Post hoc analysis from the INHALE-1 study indicates that children and adolescents achieving HbA1c <8% reported higher treatment satisfaction with inhaled insulin compared to rapid-acting insulin analogs, highlighting the significant advantage of inhaled insulin in enhancing patient experience.
- Automated Insulin Delivery Systems: The study explores the use of inhaled insulin alongside automated insulin delivery systems, evaluating how different algorithms may impact glycemic control, potentially offering new personalized treatment options for diabetes management.
- Gestational Diabetes Research: MannKind's ongoing randomized crossover study compares inhaled insulin with rapid-acting insulin in gestational diabetes patients, analyzing postprandial glucose responses and hypoglycemia events, providing crucial data support for future clinical applications.
See More
United Therapeutics' Tyvaso Shows Positive Results for Lung Fibrosis
- Clinical Trial Results: United Therapeutics announced that the TETON-1 study demonstrated that the inhaled drug Tyvaso significantly improved lung function in patients with idiopathic pulmonary fibrosis, preserving more lung function after one year compared to the placebo group, indicating its substantial potential in enhancing patient health.
- Reduced Disease Progression Risk: The study revealed that patients using Tyvaso experienced a 33% lower risk of their condition worsening, which not only enhances patient quality of life but also provides strong support for the drug's efficacy in clinical applications.
- FDA Approval Plans: United Therapeutics plans to request priority review from the FDA by the end of summer; if granted, Tyvaso could become the first new treatment option for idiopathic pulmonary fibrosis in years, representing significant market potential.
- Partnership Dynamics: MannKind Corporation serves as a manufacturing partner, supplying the dry-powder version of Tyvaso using its Technosphere technology and earning royalties on sales, which will further drive the market promotion and sales of Tyvaso.
See More
VentriPoint Diagnostics Showcases AI Cardiac Imaging Platform at Major Conference
- Market Growth Potential: The global point-of-care diagnostics market reached $58.76 billion in 2026, growing nearly 10% annually, with projections to hit $114.65 billion by 2035, indicating strong market demand and investment opportunities.
- Technology Innovation Showcase: VentriPoint will present its VMS+™ 4.0 platform at the AEPC annual meeting in Padua, Italy, which converts standard 2D ultrasound scans into detailed 3D heart models, providing results comparable to cardiac MRI and significantly enhancing clinical diagnostic efficiency.
- International Expansion and Collaboration: VentriPoint has partnered with Lishman Global to submit VMS+™ 4.0 for approval to China's National Medical Products Administration, utilizing the expedited
See More
VentriPoint Diagnostics Showcases AI Cardiac Imaging Platform at Major Conference
- Market Growth Potential: The global point-of-care diagnostics market reached $58.76 billion in 2026, growing nearly 10% annually, with projections to hit $114.65 billion by 2035, indicating strong demand for rapid and convenient healthcare solutions that create significant opportunities for companies like VentriPoint.
- Showcase Opportunity: VentriPoint will present its AI-powered VMS+™ 4.0 cardiac imaging platform at the 59th Annual Meeting of the Association for European Paediatric and Congenital Cardiology in Padua, Italy, expected to attract over 1,000 cardiology specialists from 32 countries, enhancing brand visibility and market penetration.
- Regulatory Expansion Progress: VentriPoint's strategic partner Lishman Global has formally submitted VMS+™ 4.0 for approval to China's National Medical Products Administration, leveraging the expedited
See More
FDA Approves Afrezza for Pediatric Diabetes Management
- New Drug Approval: The FDA has approved MannKind's Afrezza inhalation powder for children and adolescents aged 6 and older with diabetes, representing a new treatment option that is expected to improve the quality of life for over 350,000 children in the U.S.
- Clinical Support: This approval is backed by positive results from the INHALE-1 clinical trial, along with safety and efficacy data accumulated over 20 years of Technosphere® inhaled insulin development, showcasing Afrezza's advantages in rapid absorption and ease of use.
- Economic Accessibility: Eligible patients can now access Afrezza for $35 or less per month, with MannKind Cares providing dedicated support to help patients obtain medications and insurance information, thereby reducing the financial burden of diabetes treatment.
- Personalized Treatment: Afrezza's rapid onset allows for dosing at mealtime, catering to the daily lives of children and adolescents, offering a needle-free insulin option that aligns with family needs and advancing the progress of personalized medicine.
See More
MannKind Set to Present Afrezza Data Amid FDA Decision
- FDA Decision Focus: MannKind's inhaled insulin Afrezza has a PDUFA target action date of May 29, which, if approved, would allow use in children aged 4 to 17, potentially expanding the market and boosting company performance significantly.
- Clinical Trial Results: The Phase 3 trial results released last October demonstrated that Afrezza, when used alongside multiple daily insulin injections, effectively improves blood sugar control and enhances treatment satisfaction, further supporting the FDA application.
- Market Sentiment Shift: Investor sentiment has shifted from neutral to bullish ahead of the FDA decision, with many users on social media discussing the potential for significant stock price increases post-approval, indicating strong market confidence in MannKind.
- Data Presentation Plans: MannKind is set to present additional Afrezza-related data at the American Diabetes Association Scientific Sessions, including analyses on pediatric treatment satisfaction and A1c tests, further enhancing the company's influence in diabetes treatment.
See More
MannKind Unveils New Afrezza Data Ahead of FDA Review
- Pediatric Clinical Data: MannKind will present new efficacy data for Afrezza in children and adolescents with diabetes at the 2026 American Diabetes Association Scientific Sessions, potentially advancing the FDA review process set for May 29, 2026, which could provide the first needle-free insulin option for pediatric patients.
- Patient Satisfaction Analysis: Post hoc analysis from the INHALE-1 study indicates that children and adolescents achieving HbA1c <8% reported higher treatment satisfaction with inhaled insulin compared to rapid-acting insulin analogs, highlighting the significant advantage of inhaled insulin in enhancing patient experience.
- Automated Insulin Delivery Systems: The study explores the use of inhaled insulin alongside automated insulin delivery systems, evaluating how different algorithms may impact glycemic control, potentially offering new personalized treatment options for diabetes management.
- Gestational Diabetes Research: MannKind's ongoing randomized crossover study compares inhaled insulin with rapid-acting insulin in gestational diabetes patients, analyzing postprandial glucose responses and hypoglycemia events, providing crucial data support for future clinical applications.
See More
United Therapeutics' Tyvaso Shows Positive Results for Lung Fibrosis
- Clinical Trial Results: United Therapeutics announced that the TETON-1 study demonstrated that the inhaled drug Tyvaso significantly improved lung function in patients with idiopathic pulmonary fibrosis, preserving more lung function after one year compared to the placebo group, indicating its substantial potential in enhancing patient health.
- Reduced Disease Progression Risk: The study revealed that patients using Tyvaso experienced a 33% lower risk of their condition worsening, which not only enhances patient quality of life but also provides strong support for the drug's efficacy in clinical applications.
- FDA Approval Plans: United Therapeutics plans to request priority review from the FDA by the end of summer; if granted, Tyvaso could become the first new treatment option for idiopathic pulmonary fibrosis in years, representing significant market potential.
- Partnership Dynamics: MannKind Corporation serves as a manufacturing partner, supplying the dry-powder version of Tyvaso using its Technosphere technology and earning royalties on sales, which will further drive the market promotion and sales of Tyvaso.
See More
VentriPoint Diagnostics Showcases AI Cardiac Imaging Platform at Major Conference
- Market Growth Potential: The global point-of-care diagnostics market reached $58.76 billion in 2026, growing nearly 10% annually, with projections to hit $114.65 billion by 2035, indicating strong market demand and investment opportunities.
- Technology Innovation Showcase: VentriPoint will present its VMS+™ 4.0 platform at the AEPC annual meeting in Padua, Italy, which converts standard 2D ultrasound scans into detailed 3D heart models, providing results comparable to cardiac MRI and significantly enhancing clinical diagnostic efficiency.
- International Expansion and Collaboration: VentriPoint has partnered with Lishman Global to submit VMS+™ 4.0 for approval to China's National Medical Products Administration, utilizing the expedited
See More
VentriPoint Diagnostics Showcases AI Cardiac Imaging Platform at Major Conference
- Market Growth Potential: The global point-of-care diagnostics market reached $58.76 billion in 2026, growing nearly 10% annually, with projections to hit $114.65 billion by 2035, indicating strong demand for rapid and convenient healthcare solutions that create significant opportunities for companies like VentriPoint.
- Showcase Opportunity: VentriPoint will present its AI-powered VMS+™ 4.0 cardiac imaging platform at the 59th Annual Meeting of the Association for European Paediatric and Congenital Cardiology in Padua, Italy, expected to attract over 1,000 cardiology specialists from 32 countries, enhancing brand visibility and market penetration.
- Regulatory Expansion Progress: VentriPoint's strategic partner Lishman Global has formally submitted VMS+™ 4.0 for approval to China's National Medical Products Administration, leveraging the expedited
See More
