MannKind Unveils New Afrezza Data Ahead of FDA Review
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 4 days ago
0mins
Source: Newsfilter
- 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.
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Wall Street analysts forecast MNKD stock price to rise
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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 MannKind's Afrezza for Children with Diabetes
- Pediatric Drug Expansion: MannKind Corp. announced that the FDA has approved its Afrezza (human insulin inhalation powder) for children aged 6 and older with type 1 and type 2 diabetes, significantly enhancing the drug's availability for this specific patient population and addressing their medication needs.
- Clinical Trial Support: This approval is backed by results from the pivotal INHALE-1 clinical trial, along with evaluations of safety, efficacy, and long-term exposure data for inhaled insulin over the past two decades, demonstrating Afrezza's potential benefits in pediatric patients.
- Reduced Economic Burden: Afrezza is now available to eligible patients for $35 or less per month, a pricing strategy aimed at alleviating the financial burden on patients, thereby increasing the drug's accessibility and usage rates.
- Company Commitment: MannKind emphasizes its commitment to helping patients access prescribed medications and minimizing barriers to care, reflecting the company's strategic goal of improving patient quality of life.
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FDA Approves Afrezza for Pediatric Use, First Inhaled Insulin
- FDA Approval: Afrezza is now the only ultra-rapid-acting inhaled insulin approved by the FDA for improving glycemic control in children and adults, marking a significant milestone in diabetes treatment and is expected to enhance MannKind's market share.
- Clinical Trial Support: The FDA's approval was backed by data from the INHALE-1 study involving 230 patients aged 4 to 17, demonstrating that Afrezza met its primary endpoint of noninferiority in reducing HbA1c levels compared to traditional injections, bolstering clinical confidence in its use.
- Increased Patient Satisfaction: Pediatric patients using Afrezza reported significantly higher satisfaction rates and less weight gain compared to those in the injectable group, which not only improves quality of life but may also attract more families to this new therapy.
- Optimistic Market Sentiment: Retail sentiment on Stocktwits is described as “extremely bullish” with high message volumes indicating investor confidence in the Technosphere technology, despite MNKD stock having lost nearly 34% year-to-date.
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MannKind Receives FDA Approval for Afrezza in Children
- FDA Approval Announcement: MannKind Corporation has announced that its inhaled insulin Afrezza has received FDA approval for use in children and adolescents aged 6 and older with diabetes, significantly expanding its market reach and addressing the treatment needs of pediatric diabetes patients.
- Management Conference Call: CEO Michael Castagna and Senior VP Kevin Kaiserman will host a conference call on May 29, 2026, at 4:30 PM Eastern to discuss the details of the FDA approval and its implications for the company's future.
- Live Webcast Link: The conference will feature a live audio webcast available on MannKind's website, with recorded versions accessible for approximately 90 days post-event, enhancing transparency for investors and the public regarding company developments.
- Company Vision: MannKind is dedicated to transforming chronic disease care through innovative, patient-centric solutions, focusing on cardiometabolic and orphan lung diseases, aiming to meet serious unmet medical needs such as diabetes, thereby strengthening its position in the biopharmaceutical sector.
See More
MannKind's Inhaled Insulin Approved for Children
- FDA Approval Expansion: The U.S. FDA has approved MannKind's request to expand the use of its inhaled insulin, Afrezza, to children aged six and older, marking a significant advancement in diabetes treatment for the company.
- Clinical Trial Support: This label expansion is supported by MannKind's pivotal INHALE-1 clinical trial, which demonstrated Afrezza's efficacy in patients with type 1 and type 2 diabetes, further enhancing its market competitiveness.
- Needle-Free Injection Advantage: Afrezza delivers insulin directly into the bloodstream via a small, portable inhaler, providing a rapid-acting, needle-free option that meets the needs of pediatric patients seeking convenient treatment.
- Pricing Strategy: MannKind has set the starting price for Afrezza at $35 per month, which is expected to attract more families to choose this innovative treatment option, thereby driving revenue growth for the company.
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
FDA Approves MannKind's Afrezza for Children with Diabetes
- Pediatric Drug Expansion: MannKind Corp. announced that the FDA has approved its Afrezza (human insulin inhalation powder) for children aged 6 and older with type 1 and type 2 diabetes, significantly enhancing the drug's availability for this specific patient population and addressing their medication needs.
- Clinical Trial Support: This approval is backed by results from the pivotal INHALE-1 clinical trial, along with evaluations of safety, efficacy, and long-term exposure data for inhaled insulin over the past two decades, demonstrating Afrezza's potential benefits in pediatric patients.
- Reduced Economic Burden: Afrezza is now available to eligible patients for $35 or less per month, a pricing strategy aimed at alleviating the financial burden on patients, thereby increasing the drug's accessibility and usage rates.
- Company Commitment: MannKind emphasizes its commitment to helping patients access prescribed medications and minimizing barriers to care, reflecting the company's strategic goal of improving patient quality of life.
See More
U.S. Stocks Hit Record Highs, Dell Shares Surge 33%
- Strong U.S. Market Performance: The S&P 500 rose by 0.2%, the Dow Jones increased by 0.7%, and the Nasdaq 100 gained 0.4%, all reaching record highs, reflecting investor optimism due to easing U.S.-Iran tensions, which has bolstered market confidence.
- Dell's Stock Surge: Dell's shares jumped 33% on Friday, marking its best single-day performance ever, indicating strong market expectations for its role in the artificial intelligence sector, thereby solidifying its leadership position among tech stocks.
- Impressive ETF Performance: The SPDR S&P 500 ETF and Invesco QQQ Trust rose by 0.2% and 0.4%, respectively, both hitting record highs by the weekend, showcasing sustained investor enthusiasm for tech stocks, particularly driven by advancements in AI technology.
- Optimistic Market Sentiment: Retail sentiment for SPY, QQQ, and DIA on Stocktwits is in the “extremely bullish” territory, indicating a significant increase in investor confidence regarding future market trends, which could further propel stock market gains.
See More
FDA Approves Afrezza for Pediatric Use, First Inhaled Insulin
- FDA Approval: Afrezza is now the only ultra-rapid-acting inhaled insulin approved by the FDA for improving glycemic control in children and adults, marking a significant milestone in diabetes treatment and is expected to enhance MannKind's market share.
- Clinical Trial Support: The FDA's approval was backed by data from the INHALE-1 study involving 230 patients aged 4 to 17, demonstrating that Afrezza met its primary endpoint of noninferiority in reducing HbA1c levels compared to traditional injections, bolstering clinical confidence in its use.
- Increased Patient Satisfaction: Pediatric patients using Afrezza reported significantly higher satisfaction rates and less weight gain compared to those in the injectable group, which not only improves quality of life but may also attract more families to this new therapy.
- Optimistic Market Sentiment: Retail sentiment on Stocktwits is described as “extremely bullish” with high message volumes indicating investor confidence in the Technosphere technology, despite MNKD stock having lost nearly 34% year-to-date.
See More
MannKind Receives FDA Approval for Afrezza in Children
- FDA Approval Announcement: MannKind Corporation has announced that its inhaled insulin Afrezza has received FDA approval for use in children and adolescents aged 6 and older with diabetes, significantly expanding its market reach and addressing the treatment needs of pediatric diabetes patients.
- Management Conference Call: CEO Michael Castagna and Senior VP Kevin Kaiserman will host a conference call on May 29, 2026, at 4:30 PM Eastern to discuss the details of the FDA approval and its implications for the company's future.
- Live Webcast Link: The conference will feature a live audio webcast available on MannKind's website, with recorded versions accessible for approximately 90 days post-event, enhancing transparency for investors and the public regarding company developments.
- Company Vision: MannKind is dedicated to transforming chronic disease care through innovative, patient-centric solutions, focusing on cardiometabolic and orphan lung diseases, aiming to meet serious unmet medical needs such as diabetes, thereby strengthening its position in the biopharmaceutical sector.
See More
MannKind's Inhaled Insulin Approved for Children
- FDA Approval Expansion: The U.S. FDA has approved MannKind's request to expand the use of its inhaled insulin, Afrezza, to children aged six and older, marking a significant advancement in diabetes treatment for the company.
- Clinical Trial Support: This label expansion is supported by MannKind's pivotal INHALE-1 clinical trial, which demonstrated Afrezza's efficacy in patients with type 1 and type 2 diabetes, further enhancing its market competitiveness.
- Needle-Free Injection Advantage: Afrezza delivers insulin directly into the bloodstream via a small, portable inhaler, providing a rapid-acting, needle-free option that meets the needs of pediatric patients seeking convenient treatment.
- Pricing Strategy: MannKind has set the starting price for Afrezza at $35 per month, which is expected to attract more families to choose this innovative treatment option, thereby driving revenue growth for the company.
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
