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Source document· July 29, 2026

MannKind Reports Positive Phase 1b INFLO-1 Results, Demonstrating Safety and Tolerability of Nintedanib DPI and Clinical Validation of Its DPI Technology in IPF

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MannKind Reports Positive Phase 1b INFLO-1 Results, Demonstrating Safety and Tolerability of Nintedanib DPI and Clinical Validation of Its DPI Technology in IPF Generally well-tolerated with no serious adverse events, bronchospasm or diarrhea; no study drug discontinuations 90% of patients had no [60%] or mild [30%] co…
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  • According to the American Lung Association and GlobalData, there are an estimated 100,000 IPF patients in the U.S., a 20% rise in the last decade, and IPF affects an estimated 1-1.5 million people worldwide.

    60% confidence
  • The INFLO-1 results represent an important milestone for MannKind's nintedanib DPI program and further validate the potential of the Technosphere platform in pulmonary fibrosis; across Phase 1a and 1b studies, participants have received more than 700 inhalations of nintedanib DPI, including nearly 450 administered to people living with IPF, and cough was not a meaningful barrier to treatment.

    60% confidence
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Q4 2026 Biotech Catalyst Cluster: Late-Stage Data and PDUFA Dates Converge
Early-to-mid November 2026 is a dense run of clinical readouts and Q3 earnings at AHA, AASLD, ACR and ASH. Mid-cap biotechs (Vir, Mineralys, Arrowhead, Oryzon, Novartis, J&J) are reporting data that feeds into regulatory decisions. The next ones are the ivonescimab BLA (Nov 14) and the lorundrostat PDUFA (Dec 22), followed by ECLIPSE 2/3 and Maritime-1 readouts in Q1 2027. The list also includes an unrelated delisting track (EGM Nov 19, application Jan 25, 2027), and the facts have no AI or fintech content.
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MannKind Reports Positive Phase 1b INFLO-1 Results, Demonstrating Safety and Tolerability of Nintedanib DPI and Clinical Validation of Its DPI Technology in IPF: Source | Via News | fr.via.news