MANNKIND CORP

MannKind Corporation announced new clinical and real-world data for Afrezza (insulin human) Inhalation Powder and FUROSCIX (furosemide injection) to be presented at the American Diabetes Association's 2026 Scientific Sessions. The data reinforces Afrezza's established safety and efficacy, particularly in pediatric patients following its recent FDA approval, and highlights benefits beyond glycemic control. Findings also support Afrezza's potential use in gestational diabetes and provide insights into its use with automated insulin delivery systems, while FUROSCIX data showed reduced hospitalizations in heart failure patients.

MannKind Corporation announced significant progress in its nintedanib DPI program for idiopathic pulmonary fibrosis (IPF), completing patient randomization in the Phase 1b INFLO-1 trial and enrolling the first patient in the global Phase 2 INFLO-2 study. The company anticipates reporting data from the INFLO-1 study in Q3 2026, which will provide initial safety, tolerability, and pharmacokinetic assessments. This inhaled therapy aims to deliver nintedanib directly to the lungs, potentially improving tolerability and adherence compared to the oral version.

MannKind Corporation announced that the U.S. Food and Drug Administration (FDA) has approved Afrezza (insulin human) Inhalation Powder for use in children and adolescents aged 6 and older. This expanded indication targets both type 1 and type 2 diabetes, addressing a significant patient population of over 350,000 children and adolescents in the United States. The FDA also confirmed that this supplemental biologics license application has fulfilled the final postmarketing requirement for Afrezza, as stipulated in its initial 2014 approval.

MannKind Corporation announced that the FDA has approved Afrezza® for use in children and adolescents aged 6 and older living with diabetes. To discuss this significant regulatory milestone, the company's management will host a conference call on Friday, May 29, 2026, at 4:30 p.m. Eastern. The call will feature presentations from CEO Michael Castagna and Senior Vice President Kevin Kaiserman, with webcast details available on the company's investor relations website.

MannKind Corporation announced that the U.S. Food and Drug Administration (FDA) has approved Afrezza (insulin human) Inhalation Powder for use in children and adolescents aged 6 and older living with type 1 and type 2 diabetes. This approval expands Afrezza's availability beyond adults, offering a new needle-free mealtime insulin option that allows dosing at the start of a meal. The decision is supported by the Phase 3 INHALE-1 study and extensive clinical data, aiming to provide flexibility for pediatric patients managing their condition.

MannKind announced that the FDA has released the company from a significant five-year postmarketing requirement for Afrezza, which assessed the risk of pulmonary malignancy. This leaves only the pediatric efficacy and safety assessment as a remaining postmarketing requirement. Additionally, the FDA has set a PDUFA target action date of May 29, 2026, for the supplemental Biologics License Application for Afrezza in pediatric patients. The company also provided an update on its INHALE-1st clinical study, activating eight new sites to enroll participants.

MannKind Corporation announced that its Chief Executive Officer, Michael Castagna, PharmD, will participate in a fireside chat at the 2026 Jefferies Global Healthcare Conference. The presentation is scheduled for June 3 at 9:20 a.m. ET. A live audio webcast will be available on the company's investor relations website, with a recorded version accessible for approximately 90 days following the conference.

MannKind Corporation announced that new clinical and real-world data for Afrezza and FUROSCIX will be presented at the American Diabetes Association's 2026 Scientific Sessions. This comes as the company approaches the PDUFA target action date of May 29, 2026, for Afrezza's approval in pediatric patients. The presentations will cover various aspects including pediatric efficacy, patient satisfaction, use with AID algorithms, and gestational diabetes, further strengthening the understanding of inhaled insulin across diverse patient populations.

MannKind reported a net loss of $(16.6) million for Q1 2026, a significant decline from a net income of $13.2 million in Q1 2025, despite a 15.1% increase in total revenues to $90.2 million. The shift to a net loss was primarily driven by a substantial increase in selling, general, and administrative expenses, which more than doubled year-over-year. Commercial product sales saw strong growth, while collaboration and services revenue decreased.

MannKind Corporation reported first-quarter 2026 total revenues of $90.2 million, a 15% increase year-over-year, driven by higher royalties and Furoscix sales. However, the company posted a net loss of $16.6 million, compared to a net income of $13.2 million in Q1 2025, due to significantly increased operating expenses related to Furoscix integration and pipeline advancement. The company highlighted upcoming PDUFA dates for Afrezza pediatric indication (May 29, 2026) and Furoscix ReadyFlow Autoinjector (July 26, 2026), alongside progress in its development pipeline and an expanded collaboration with United Therapeutics for ralinepag DPI.