Core Viewpoint - MannKind Corporation has initiated the INHALE-1 clinical study to evaluate the safety and efficacy of Afrezza inhaled insulin in youth aged 10 to under 18 years recently diagnosed with type 1 diabetes, aiming to reduce the burden of insulin injections for pediatric patients and their families [1][2]. Group 1: Study Details - The INHALE-1 study will assess Afrezza used in combination with subcutaneously injected basal insulin once daily, focusing on clinical outcomes and participant satisfaction [2]. - The study will enroll approximately 100 patients across about 10 clinical sites in the United States, with the first patient enrolled at the Barbara Davis Center for Diabetes in Aurora, Colorado [3]. - Participants will be followed for 13 weeks during the main phase, with an optional extension phase for up to 26 weeks [4]. Group 2: Primary Endpoint and Objectives - The primary endpoint is the percentage of participants with a Continuous Glucose Meter (CGM) measuring time in range (TIR) of 70-180 mg/dL at least 70% during the 14 days prior to the 13-week visit [4]. - The study aims to evaluate whether replacing most insulin injections with inhalations can ease the adjustment to managing type 1 diabetes for children and their families [2]. Group 3: Regulatory Status - The FDA is currently reviewing a supplemental Biologics License Application (sBLA) for Afrezza in children and adolescents with type 1 or type 2 diabetes, with a target action date of May 29, 2026 [5]. - If approved, Afrezza would be the first needle-free insulin option for pediatric patients in over a century [5]. Group 4: Company Overview - MannKind Corporation is focused on transforming chronic disease care through innovative solutions, particularly in cardiometabolic and orphan lung diseases [9][10]. - The company aims to develop treatments that address serious unmet medical needs, including diabetes and related conditions [9].

Core Viewpoint - MannKind Corporation announced the FDA's approval of an updated prescribing information for Afrezza, which includes revised recommendations for starting mealtime dosages when transitioning patients from subcutaneous insulin to inhaled insulin [1][2]. Group 1: FDA Approval and Label Update - The updated label aims to provide clearer guidance for healthcare providers on starting doses when switching patients to Afrezza from subcutaneous insulin [2]. - The label update is supported by modeling data and results from the Dose Optimization study and the INHALE-3 trial, which showed improved postprandial glucose outcomes with the new dosing recommendations [2][4]. Group 2: Recommended Dosing Information - The revised dosing recommendations include specific conversions from injected mealtime insulin to Afrezza, such as: - Up to 3 units of subcutaneous insulin corresponds to 4 units of Afrezza - 4 to 5 units corresponds to 8 units - 6 to 7 units corresponds to 12 units [5][4]. Group 3: Product Overview - Afrezza is the only ultra-rapid acting inhaled insulin approved by the FDA for improving glycemic control in adults with diabetes mellitus, utilizing MannKind's Technosphere technology for rapid absorption [6]. - The product is administered at the beginning of meals using a portable inhaler, mimicking the body's natural insulin response [6]. Group 4: Safety Information - Afrezza is contraindicated in patients with chronic lung diseases such as asthma or COPD due to the risk of acute bronchospasm [7][12]. - The most common adverse reactions associated with Afrezza include hypoglycemia, cough, and throat irritation [18].

Core Insights - MannKind Corporation is focused on transforming chronic disease care through innovative solutions for cardiometabolic and orphan lung diseases, with significant growth anticipated in 2026 [1][3] Business Updates - MannKind closed 2025 with a record-setting fourth quarter, surpassing $100 million in net revenue, and completed the acquisition of scPharmaceuticals [2] - The company is preparing for two high-potential product launches in 2026, which are expected to drive long-term value creation [2] Major Catalysts for 2026 - Afrezza (insulin human) Inhalation Powder is a key product with an FDA decision on a label update anticipated by January 23, 2026, which would update the initial dose for mealtime insulin [5] - The FDA has accepted for review the supplemental Biologics License Application for Afrezza in children and adolescents, with a target action date of May 29, 2026, potentially making it the first needle-free insulin option for pediatric patients in over a century [5] - FUROSCIX ReadyFlow Autoinjector has also been accepted for review by the FDA, with a target action date of July 26, 2026, which would deliver an IV-equivalent diuretic dose in under 10 seconds if approved [5] - Nintedanib DPI (MNKD-201) has enrolled its first patient in a Phase 1b study, with further developments expected in 2026 [5] - The company is advancing pre-clinical development for Bumetanide DPI (MNKD-701) and formulating a second dry powder investigational molecule under collaboration with United Therapeutics [5]

Core Points - MannKind Corporation, in partnership with Alfred E. Mann Charities and The Diabetes Link, launched the Centennial Al Mann Scholarship to honor the legacy of its founder Alfred E. Mann, distributing $100,000 in scholarship funds to support young adults living with diabetes pursuing higher education in life sciences [1][2][8] - The scholarship program aims to empower students aged 18-22 with type 1 or type 2 diabetes, providing up to $10,000 per recipient, distributed in annual installments of $2,500 [3][4] - The initiative reflects Alfred E. Mann's commitment to improving human life through medical advancement and philanthropy, continuing his vision of giving back to the community [2][5] Company Overview - MannKind Corporation is a biopharmaceutical company focused on transforming chronic disease care through innovative, patient-centric solutions, particularly in cardiometabolic and orphan lung diseases [6][7] - The company has a history of developing breakthrough medical devices and treatments, including the inhaled insulin product Afrezza, which was brought to market with a significant investment of nearly $1 billion by Alfred E. Mann [5][6] Partnership and Community Impact - The partnership with The Diabetes Link aims to expand access to higher education for young adults with diabetes, addressing the rising costs of college and easing financial burdens [5][12] - The Diabetes Link is a national nonprofit organization dedicated to empowering young adults living with diabetes through peer support and resources, envisioning a future where they thrive in their personal and professional lives [12]

Core Insights - MannKind Corporation announced that the FDA has accepted the supplemental biologics license application (sBLA) for Afrezza, seeking approval for use in children and adolescents with type 1 or type 2 diabetes, with a PDUFA target action date of May 29, 2026 [1][8] Company Overview - MannKind Corporation is a biopharmaceutical company focused on innovative solutions for chronic diseases, particularly in cardiometabolic and orphan lung diseases, including diabetes [6][7] Product Information - Afrezza is a rapid-acting inhaled human insulin indicated for improving glycemic control in adults with diabetes mellitus, and it has been available for adults since June 2014 [3][4] - If approved for pediatric use, Afrezza would be the first needle-free insulin option for children in over 100 years [8] Clinical Study Details - The sBLA is based on the Phase 3 INHALE-1 study, which involved children and adolescents aged 4-17, comparing Afrezza with multiple daily injections (MDI) [2][8] - The study's six-month topline results were reported in December 2024, and full results will be presented at the International Society for Pediatric and Adolescent Diabetes (ISPAD) in early November [2]

Core Insights - MannKind Corporation will showcase its inhaled insulin product, Afrezza, at the American Diabetes Association's 85th Scientific Sessions from June 20-23, 2025, in Chicago [1][5] - Dr. Michael J. Haller will present results from the INHALE-1 clinical trial, focusing on inhaled insulin treatment for children and adolescents aged 4-17 [2][3] - MannKind plans to submit a Supplemental Biologics License Application for a pediatric indication for Afrezza in mid-2025, following the release of topline results from the full pediatric data set in Q2 2025 [5] Company Overview - MannKind Corporation specializes in developing and commercializing inhaled therapeutic products and delivery devices for endocrine and orphan lung diseases [6][7] - The company aims to address serious unmet medical needs through innovative dry-powder formulations and inhalation devices, providing rapid and convenient delivery of medications [7] Upcoming Events - The ADA's Scientific Sessions will feature a symposium titled "Future Ready," where breakthrough advancements in pediatric Type 1 diabetes care will be discussed [3] - MannKind will host a booth (1617) at the event for scientific exchange and to showcase its products [4]