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DANBURY, Conn. and WESTLAKE VILLAGE, Calif. - MannKind Corporation (NASDAQ:MNKD), a biopharmaceutical company with a market capitalization of $1.33 billion and impressive 32.5% year-over-year revenue growth, is set to present findings from its INHALE-1 clinical trial at the upcoming American Diabetes Association’s 85th Scientific Sessions. The trial focuses on Afrezza, an inhaled insulin powder for pediatric use. According to InvestingPro analysis, the company maintains a strong financial health score of 3.42, labeled as "GREAT," with liquid assets exceeding short-term obligations.
During the event, which takes place from June 20-23 in Chicago, Dr. Michael J. Haller will share the randomized trial results. The study involves children and adolescents with Type 1 diabetes, aiming to demonstrate the efficacy and safety of Afrezza compared to traditional insulin delivery methods.
Also on the agenda, Dr. Peter Calhoun will discuss patient-reported outcomes using inhaled Technosphere Insulin, and Dr. K M Prasanna Kumar will present phase III clinical trial results comparing Afrezza with a placebo in adults with Type 2 diabetes.
MannKind anticipates releasing the complete pediatric study data in the second quarter of 2025 and plans to submit a Supplemental Biologics License Application (sBLA) for a pediatric indication of Afrezza mid-year.
The company’s participation in the ADA sessions underscores its commitment to addressing the needs of those with endocrine and orphan lung diseases through innovative inhalation technology. MannKind’s booth at the conference will serve as a hub for scientific exchange on these advances.
This announcement is based on a press release statement and reflects the company’s current expectations. However, actual results may vary due to a range of risks and uncertainties. MannKind’s future plans include the potential expansion of Afrezza’s indications, pending regulatory review and approval processes.
In other recent news, MannKind Corporation reported its Q1 2025 financial performance, highlighting a notable revenue increase that exceeded expectations. The company achieved a revenue of $78.35 million, marking an 18% year-over-year growth, driven by a 32% increase in Tyvaso DPI royalties and an 18% rise in collaboration and services revenue. Despite this strong revenue performance, earnings per share (EPS) slightly missed projections, coming in at $0.04 compared to the anticipated $0.042. In leadership news, MannKind announced the departure of Chief Medical Officer Burkhard Blank, with a structured transition plan in place. Blank will remain with the company as a non-executive employee until August 1, 2025, and will receive continued salary and a special bonus as part of his separation agreement.
The company is also preparing for potential approval of pediatric Afrezza and anticipates continued growth in Tyvaso DPI royalties. Additionally, MannKind’s CEO expressed optimism about the company’s future, emphasizing the potential of their inhaled therapy platform. These developments are part of MannKind’s strategic growth initiatives and ongoing pipeline advancements.
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